Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-02-25 @ 9:50 PM
Study NCT ID:
NCT02160002
Status:
COMPLETED
Last Update Posted:
2019-03-22
First Post:
2014-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Incubator Weaning of Moderately Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sshankar@med.wayne.edu', 'phone': '(313) 745-1436', 'title': 'Seetha Shankaran', 'organization': 'Wayne State University'}, 'certainAgreement': {'otherDetails': 'Investigators must adhere to the Neonatal Research Network Publication policies.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events are monitored from the time of randomization through 72 hours post study intervention completion. The study intervention period is defined as from the time of randomization to the end of a successful wean or failure.', 'description': 'Potential adverse events include inability to maintain temperature in crib, bradycardia, weight loss or lack of weight gain and feeding intolerance during the safety monitoring period.', 'eventGroups': [{'id': 'EG000', 'title': 'Lower Weight (1600 Grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)', 'otherNumAtRisk': 187, 'deathsNumAtRisk': 187, 'otherNumAffected': 19, 'seriousNumAtRisk': 187, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Higher Weight (1800 Grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)', 'otherNumAtRisk': 179, 'deathsNumAtRisk': 179, 'otherNumAffected': 7, 'seriousNumAtRisk': 179, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Moderate cold stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe cold stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeding Intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Desaturations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NEC IIa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia with desaturations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increasing heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pneumoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Weight (1600 Grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)'}, {'id': 'OG001', 'title': 'Higher Weight (1800 Grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '55'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '52'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From birth through discharge', 'description': 'Number of days the infant stays in hospital after birth until discharge home (up to 120 days).', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '185 infants in the lower weight group and 178 infants in the higher weight group have the date of discharge available.'}, {'type': 'SECONDARY', 'title': 'Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Weight (1600 Grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)'}, {'id': 'OG001', 'title': 'Higher Weight (1800 Grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '35'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of weaning from the incubator to crib through discharge (up to 120 days)', 'description': 'Among infants who were successfully weaned, the number of days in the hospital counting from the start of weaning from the incubator to the crib through discharge from the hospital (up to 120 days).', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 163 infants in the Lower Weight group that were successfully weaned from incubator to the crib; discharge date was missing for one of these infants. There were 159 infants in the Higher Weight group that were successfully weaned from incubator to the crib; 4 infants were missing start of weaning dates because of protocol violations.'}, {'type': 'SECONDARY', 'title': 'Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Weight (1600 Grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)'}, {'id': 'OG001', 'title': 'Higher Weight (1800 Grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through completion of 2 weaning attempts', 'description': 'Failure of wean is defined as axillary temperature less than 36.3°C after one hour in the crib on 2 successive readings, 3 to 4 hours apart, within 24 hours of weaning to the crib in spite of additional clothes/coverings.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '178 infants in the Lower Weight group and 167 infants in the Higher Weight group have the data on whether weaning from incubator to crib was successful after two attempts at weaning.'}, {'type': 'SECONDARY', 'title': 'Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Weight (1600 Grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)'}, {'id': 'OG001', 'title': 'Higher Weight (1800 Grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)'}], 'classes': [{'categories': [{'measurements': [{'value': '15.8', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Start of weaning from incubator through 36 weeks postmenstrual age (PMA)', 'description': 'Growth velocity in terms of weight (g/kg/day), considering infant weight at start of weaning from incubator to crib (following random assignment) and weight at 36 weeks postmenstrual age (PMA).', 'unitOfMeasure': 'grams/kilograms/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 257 (136 LW and 121 HW) infants who remained in the hospital at 36 weeks PMA that have weights measured at 36 weeks PMA. Twenty six infants (10 LW and 16 HW) who were still in the incubator at 36 weeks PMA and 20 infants (7 LW and 13 HW) missing the date of start of weaning were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Growth Parameters: Weight at Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Weight (1600 Grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)'}, {'id': 'OG001', 'title': 'Higher Weight (1800 Grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)'}], 'classes': [{'categories': [{'measurements': [{'value': '2336.3', 'spread': '648.0', 'groupId': 'OG000'}, {'value': '2353.6', 'spread': '522.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Status (discharge, death, transfer to another facility, or 120 days)', 'description': 'Infant weight at status is measured at the time of discharge, death, transfer to another facility, or 120 days.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '185 infants in the Lower Weight group and 177 infants in the Higher Weight group had their weights recorded upon reaching status.'}, {'type': 'SECONDARY', 'title': 'Growth Parameters: Length at Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Weight (1600 Grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)'}, {'id': 'OG001', 'title': 'Higher Weight (1800 Grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)'}], 'classes': [{'categories': [{'measurements': [{'value': '44.6', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '44.9', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Status (discharge, death, transfer to another facility, or 120 days)', 'description': 'Infant length at status is measured at the time of discharge, death, transfer to another facility, or 120 days.', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '174 infants in the Lower Weight group and 169 infants in the Higher Weight group have the length at status data.'}, {'type': 'SECONDARY', 'title': 'Growth Parameters: Head Circumference at Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Weight (1600 Grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)'}, {'id': 'OG001', 'title': 'Higher Weight (1800 Grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)'}], 'classes': [{'categories': [{'measurements': [{'value': '31.9', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '32.0', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Status (discharge, death, transfer to another facility, or 120 days)', 'description': 'Infant head circumference at status is measured at the time of discharge, death, transfer to another facility, or 120 days.', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '182 infants in the Lower Weight group and 173 infants in the Higher Weight group have the head circumference at status data.'}, {'type': 'SECONDARY', 'title': 'Postmenstrual Age (PMA) at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Weight (1600 Grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)'}, {'id': 'OG001', 'title': 'Higher Weight (1800 Grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)'}], 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'groupId': 'OG000', 'lowerLimit': '36.3', 'upperLimit': '38.9'}, {'value': '37.0', 'groupId': 'OG001', 'lowerLimit': '36.0', 'upperLimit': '38.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Discharge', 'description': 'Postmenstrual age (PMA) at discharge is the sum of the gestational age of the infant and its length of stay in hospital from birth to discharge.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '185 infants in the Lower Weight group and 178 infants in the Higher Weight group have postmenstrual age (PMA) at discharge data.'}, {'type': 'SECONDARY', 'title': 'Readmission to the Hospital Within 1 Week of Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Weight (1600 Grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)'}, {'id': 'OG001', 'title': 'Higher Weight (1800 Grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Discharge through 1 week after discharge.', 'description': 'Number of infants re-hospitalized within 1 week (7 days) of discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '174 infants in the Lower Weight group and 168 infants in the Higher Weight group had post discharge follow-up.'}, {'type': 'SECONDARY', 'title': 'Death Among Enrolled Infants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Weight (1600 Grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)'}, {'id': 'OG001', 'title': 'Higher Weight (1800 Grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Status (discharge, death, transfer to another facility, or 120 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '185 infants in the Lower Weight group and 178 infants in the Higher Weight group have status data.'}, {'type': 'SECONDARY', 'title': 'Transferred to a Non-Network Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Weight (1600 Grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)'}, {'id': 'OG001', 'title': 'Higher Weight (1800 Grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Status (discharge, death, transfer to another facility, or 120 days)', 'description': 'Number of infants transferred to another non-Network hospital.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '185 infants in the Lower Weight group and 178 infants in the Higher Weight group have status data.'}, {'type': 'SECONDARY', 'title': 'Length of Stay (LOS) Following Randomization to Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Weight (1600 Grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)'}, {'id': 'OG001', 'title': 'Higher Weight (1800 Grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '39'}, {'value': '27.5', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '37'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization through discharge.', 'description': 'The number of days the infant stayed in hospital after randomization to the study until discharge.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '185 infants in the Lower Weight group and 178 infants in the Higher Weight group have the date of discharge.'}, {'type': 'POST_HOC', 'title': 'Growth Velocity (g/kg/Day) After Transfer to Crib From Incubator to Crib to 36 Weeks Postmenstural Age (PMA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Weight (1600 Grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)'}, {'id': 'OG001', 'title': 'Higher Weight (1800 Grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '7.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours after successful wean to 36 weeks postmenstrual age (PMA)', 'description': 'Growth velocity in terms of weight (g/kg/day), considering infant weight at 24 hours after successful wean to crib and weight at 36 weeks postmenstrual age (PMA).', 'unitOfMeasure': 'grams/kilograms/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '257 infants (136 LW, 121 HW) remained in hospital at 36 weeks PMA w/ weight measured at 36 weeks PMA. 26 (10 LW, 16 HW) were still in incubator at 36 weeks PMA, 31 (16 LW, 15 HW) were missing weight after 24 hrs of successful wean, and 4 (LW) w/ weights measured at 24 hrs after successful wean were missing date of 24 hr weight after successful wean'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lower Weight (1600 Grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)'}, {'id': 'FG001', 'title': 'Higher Weight (1800 Grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '179'}]}, {'type': 'Primary Outcome', 'achievements': [{'groupId': 'FG000', 'numSubjects': '185'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '185'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '1565 infants were screened for eligibility. 1199 infants were excluded. 680 were excluded due to not meeting all eligibility conditions, 510 did not get consent for randomization, and 9 were consented but not randomized due to parent (1 infant) or doctor withdrawal (1 infant), becoming medically unstable (3 infants) or other reasons (4 infants).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '366', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lower Weight (1600 Grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)'}, {'id': 'BG001', 'title': 'Higher Weight (1800 Grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Gestational Age', 'categories': [{'measurements': [{'value': '31.2', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '31.1', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '31.1', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Postmenstrual (PMA) age at start of weaning', 'classes': [{'categories': [{'measurements': [{'value': '33.8', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '34.3', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '34.1', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Maternal Age', 'classes': [{'categories': [{'measurements': [{'value': '28.8', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '28.9', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '28.8', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cesarean Delivery', 'classes': [{'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of 366 infants were randomized in the study. 187 infants were randomized to the Lower Weight group. 179 infants were randomized to the Higher Weight group. The baseline statistics are based on the number of mothers or infants for whom data were available.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 366}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-20', 'studyFirstSubmitDate': '2014-05-08', 'resultsFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2014-06-06', 'lastUpdatePostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-28', 'studyFirstPostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)', 'timeFrame': 'From birth through discharge', 'description': 'Number of days the infant stays in hospital after birth until discharge home (up to 120 days).'}], 'secondaryOutcomes': [{'measure': 'Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days)', 'timeFrame': 'From start of weaning from the incubator to crib through discharge (up to 120 days)', 'description': 'Among infants who were successfully weaned, the number of days in the hospital counting from the start of weaning from the incubator to the crib through discharge from the hospital (up to 120 days).'}, {'measure': 'Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts)', 'timeFrame': 'Through completion of 2 weaning attempts', 'description': 'Failure of wean is defined as axillary temperature less than 36.3°C after one hour in the crib on 2 successive readings, 3 to 4 hours apart, within 24 hours of weaning to the crib in spite of additional clothes/coverings.'}, {'measure': 'Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA)', 'timeFrame': 'Start of weaning from incubator through 36 weeks postmenstrual age (PMA)', 'description': 'Growth velocity in terms of weight (g/kg/day), considering infant weight at start of weaning from incubator to crib (following random assignment) and weight at 36 weeks postmenstrual age (PMA).'}, {'measure': 'Growth Parameters: Weight at Status', 'timeFrame': 'Status (discharge, death, transfer to another facility, or 120 days)', 'description': 'Infant weight at status is measured at the time of discharge, death, transfer to another facility, or 120 days.'}, {'measure': 'Growth Parameters: Length at Status', 'timeFrame': 'Status (discharge, death, transfer to another facility, or 120 days)', 'description': 'Infant length at status is measured at the time of discharge, death, transfer to another facility, or 120 days.'}, {'measure': 'Growth Parameters: Head Circumference at Status', 'timeFrame': 'Status (discharge, death, transfer to another facility, or 120 days)', 'description': 'Infant head circumference at status is measured at the time of discharge, death, transfer to another facility, or 120 days.'}, {'measure': 'Postmenstrual Age (PMA) at Discharge', 'timeFrame': 'Discharge', 'description': 'Postmenstrual age (PMA) at discharge is the sum of the gestational age of the infant and its length of stay in hospital from birth to discharge.'}, {'measure': 'Readmission to the Hospital Within 1 Week of Discharge', 'timeFrame': 'Discharge through 1 week after discharge.', 'description': 'Number of infants re-hospitalized within 1 week (7 days) of discharge.'}, {'measure': 'Death Among Enrolled Infants', 'timeFrame': 'Status (discharge, death, transfer to another facility, or 120 days)'}, {'measure': 'Transferred to a Non-Network Hospital', 'timeFrame': 'Status (discharge, death, transfer to another facility, or 120 days)', 'description': 'Number of infants transferred to another non-Network hospital.'}, {'measure': 'Length of Stay (LOS) Following Randomization to Hospital Discharge', 'timeFrame': 'From randomization through discharge.', 'description': 'The number of days the infant stayed in hospital after randomization to the study until discharge.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Incubator Weaning', 'Moderately Preterm Infants', 'Growth Velocity'], 'conditions': ['Infant, Newborn', 'Infant, Moderate Preterm']}, 'referencesModule': {'references': [{'pmid': '31033050', 'type': 'DERIVED', 'citation': 'Chowdhary V, Shukla A. Weaning of moderately preterm infants from the incubator to the crib: a randomized clinical trial. Acta Paediatr. 2019 Jul;108(7):1364. doi: 10.1111/apa.14774. Epub 2019 Apr 29. No abstract available.'}, {'pmid': '30337189', 'type': 'DERIVED', 'citation': "Shankaran S, Bell EF, Laptook AR, Saha S, Newman NS, Kazzi SNJ, Barks J, Stoll BJ, Bara R, Gabrio J, Childs K, Das A, Higgins RD, Carlo WA, Sanchez PJ, Carlton DP, Pavageau L, Malcolm WF, D'Angio CT, Ohls RK, Poindexter BB, Sokol GM, Van Meurs KP, Colaizy TT, Khmour A, Puopolo KM, Garg M, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health, and Human Development Neonatal Research Network. Weaning of Moderately Preterm Infants from the Incubator to the Crib: A Randomized Clinical Trial. J Pediatr. 2019 Jan;204:96-102.e4. doi: 10.1016/j.jpeds.2018.08.079. Epub 2018 Oct 15."}], 'seeAlsoLinks': [{'url': 'http://neonatal.rti.org/', 'label': 'NICHD Neonatal Research Network site'}, {'url': 'http://www.nichd.nih.gov/about/org/der/branches/ppb/Pages/overview.aspx', 'label': 'NICHD Pregnancy \\& Perinatology Branch'}]}, 'descriptionModule': {'briefSummary': 'The objective of this proposal is to evaluate whether weaning from an incubator to a crib at lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay among moderately preterm infants.\n\nThe hypothesis of this study is that length of hospital stay (from birth to discharge) will be decreased among moderate preterm infants weaned from an incubator to an open crib at a lower versus higher weight, 1600g vs. 1800g.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '34 Weeks', 'minimumAge': '29 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age 29 0/7 to 33 6/7 weeks at birth\n* Birth weight less than 1600 grams\n* Greater than 48 hours of age\n* Current weight less than 1540 grams\n* In an incubator\n\nExclusion Criteria:\n\n* Receiving phototherapy\n* Receiving respiratory support (including CPAP, ventilation, HFNC \\> 2 LPM)\n* Receiving blood pressure support\n* Designated for transfer to referral hospital while in incubator\n* Known major congenital or chromosomal anomaly'}, 'identificationModule': {'nctId': 'NCT02160002', 'briefTitle': 'Incubator Weaning of Moderately Preterm Infants', 'organization': {'class': 'NETWORK', 'fullName': 'NICHD Neonatal Research Network'}, 'officialTitle': 'Incubator Weaning of Moderately Preterm Infants: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NICHD-NRN-0054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lower Weight (1600 grams)', 'description': 'Weaning from an incubator at a lower weight (1600 grams)', 'interventionNames': ['Procedure: Weaning from an incubator at a lower weight (1600 grams)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Higher Weight (1800 grams)', 'description': 'Weaning from an incubator at a higher weight (1800 grams)', 'interventionNames': ['Procedure: Weaning from an incubator at a higher weight (1800 grams)']}], 'interventions': [{'name': 'Weaning from an incubator at a lower weight (1600 grams)', 'type': 'PROCEDURE', 'description': 'Infants will be weaned from an incubator at a lower weight (1600 grams)', 'armGroupLabels': ['Lower Weight (1600 grams)']}, {'name': 'Weaning from an incubator at a higher weight (1800 grams)', 'type': 'PROCEDURE', 'description': 'Infants will be weaned from an incubator at a higher weight (1800 grams)', 'armGroupLabels': ['Higher Weight (1800 grams)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California - Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'RTI International', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Research Institute at Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Univeristy of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University, Women & Infants Hospital of Rhode Island', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Michele C Walsh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Case Western Reserve University, Rainbow Babies and Children's Hospital"}, {'name': 'Myra Wyckoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas, Southwestern Medical Center at Dallas'}, {'name': 'Seetha Shankaran, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Wayne State University'}, {'name': 'David Carlton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Kurt Schibler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}, {'name': 'Brenda B Poindexter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}, {'name': 'Abbot Laptook, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University, Women & Infants Hosptial of Rhode Island'}, {'name': 'Krisa P Van Meurs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Waldemar Carlo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Kathleen A Kennedy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}, {'name': 'Mike Cotten, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Edward F Bell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}, {'name': 'Kristi Watterberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}, {'name': 'Barbara Schmidt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': "Carl T D'Angio, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}, {'name': 'Uday Devaskar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}, {'name': 'Pablo Sanchez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Research Institute at Nationwide Children's Hospital"}, {'name': 'William Truog, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}, {'name': 'Abhik Das, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RTI International'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NICHD Neonatal Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}