Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-01 @ 5:37 AM
Study NCT ID:
NCT04325308
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-23
First Post:
2020-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D061186', 'term': 'Breast Milk Expression'}, {'id': 'D005183', 'term': 'Failure to Thrive'}, {'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'asalas@uab.edu', 'phone': '2059344680', 'title': 'Ariel Salas', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From birth up to 120 days following birth', 'eventGroups': [{'id': 'EG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 31, 'seriousNumAtRisk': 75, 'deathsNumAffected': 6, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 30, 'seriousNumAtRisk': 75, 'deathsNumAffected': 5, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Growth failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Necrotizing enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Spontaneous intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fat-free Mass(FFM)-For-age Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered'}, {'id': 'OG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks or hospital discharge, up to 120 days following birth, whichever is longer', 'description': 'Estimated by air displacement plethysmography. FFM measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019). A Z-score of 0 represents the population mean. Z-score values closer to 0 represent a better outcome. No relevant thresholds have been defined.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fat Mass(FM)-For-age Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered'}, {'id': 'OG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks or hospital discharge, up to 120 days following birth, whichever is longer', 'description': 'Estimated by air displacement plethysmography. FM measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019). A Z-score of 0 represents the population mean. Z-score values closer to 0 represent a better outcome. No relevant thresholds have been defined.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Fat(BF)-For-age Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered'}, {'id': 'OG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '1', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks or hospital discharge, up to 120 days following birth, whichever is longer', 'description': 'Body fat estimated by air displacement plethysmography. BF measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019). A Z-score of 0 represents the population mean. Z-score values closer to 0 represent a better outcome. No relevant thresholds have been defined.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anthropometric Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered'}, {'id': 'OG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.'}], 'classes': [{'title': 'Weight', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Length', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Head circumference', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first)', 'description': "Weight, length, and head circumference measurements. Measurements were converted into Z-scores based on Fenton growth curves (2013). They were calculated at birth and at 36 weeks. This outcome represents the change in weight, length, and head circumference Z-score during the course of the study (i.e., the Z-score at birth was subtracted from the Z-score at 36 weeks).\n\nA value of 0 represents that the infant's Z-score is the same at the beginning and the end of the study. Positive values indicate the increase in the infant's Z-score during the study; negative values indicate the decrease in the infant's Z-score during the study.", 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Growth Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered'}, {'id': 'OG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first)', 'description': 'Weight gain in g/kg/day', 'unitOfMeasure': 'g/kg/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Postnatal Growth Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered'}, {'id': 'OG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 weeks or hospital discharge (whichever occurred first)', 'description': 'Diagnosis of growth failure (weight \\< 10th percentile using the 2013 Fenton growth curves)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Diagnosis of Necrotizing Enterocolitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered'}, {'id': 'OG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From birth up to 120 days following birth', 'description': 'Diagnosis of necrotizing enterocolitis stage 2 or 3', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Diagnosis of Intestinal Perforation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered'}, {'id': 'OG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From birth up to 120 days following birth', 'description': 'Diagnosis of intestinal perforation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered'}, {'id': 'OG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth to 120 days', 'description': 'Death prior to 121 days of life', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Culture-proven Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered'}, {'id': 'OG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Birth to 120 days', 'description': 'Diagnosis of sepsis with positive blood cultures', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Days Alive and Receiving Full Enteral Feeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered'}, {'id': 'OG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '21'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Birth to 28 days', 'description': 'Time to full enteral feeding days', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Episodes of Feeding Intolerance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered'}, {'id': 'OG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.'}], 'timeFrame': 'Birth to 28 days', 'description': 'Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination', 'reportingStatus': 'POSTED', 'populationDescription': 'Not collected'}, {'type': 'SECONDARY', 'title': 'Duration of Hospital Stay in Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered'}, {'id': 'OG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '120'}, {'value': '107', 'groupId': 'OG001', 'lowerLimit': '79', 'upperLimit': '120'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Birth to 120 days or discharge, whichever occurs first', 'description': 'From day of admission to day of hospital discharge to home', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum BUN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered'}, {'id': 'OG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '24', 'groupId': 'OG000'}, {'value': '37', 'spread': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Birth to 28 days', 'description': 'Highest serum BUN value in the first 28 days after birth', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Intestinal Microbiome', 'timeFrame': 'Birth to 36 weeks postmenstrual age', 'description': 'Determined by molecular analyses of fecal samples', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-05'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cognitive Outcomes', 'timeFrame': '2 years of corrected age', 'description': 'Determined by Bayley assessment', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-05'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered'}, {'id': 'FG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '22'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Protein-enriched Human Milk Diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.\n\nProtein-enriched human milk diet: 1.2 g of human-based protein will be added to each 100 ml of human milk administered'}, {'id': 'BG001', 'title': 'Usual Human Milk Diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.\n\nUsual human milk diet: Human-based protein will not be added to the human milk administered.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '27'}, {'value': '26', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '27'}, {'value': '26', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks of gestation', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-23', 'size': 215651, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-30T10:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Caregivers and primary outcome evaluators will be masked. Nutrition room staff not involved in patient care will be responsible for determining participant allocation to one of the supplementation groups by opening sequentially numbered sealed envelopes, dispensing feeding syringes with the allocated human milk diet (protein-enriched or usual), and masking caregivers administering the assigned dietary intervention.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2020-03-25', 'resultsFirstSubmitDate': '2023-12-30', 'studyFirstSubmitQcDate': '2020-03-25', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-03-12', 'studyFirstPostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in Intestinal Microbiome', 'timeFrame': 'Birth to 36 weeks postmenstrual age', 'description': 'Determined by molecular analyses of fecal samples'}, {'measure': 'Cognitive Outcomes', 'timeFrame': '2 years of corrected age', 'description': 'Determined by Bayley assessment'}], 'primaryOutcomes': [{'measure': 'Fat-free Mass(FFM)-For-age Z-score', 'timeFrame': '36 weeks or hospital discharge, up to 120 days following birth, whichever is longer', 'description': 'Estimated by air displacement plethysmography. FFM measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019). A Z-score of 0 represents the population mean. Z-score values closer to 0 represent a better outcome. No relevant thresholds have been defined.'}], 'secondaryOutcomes': [{'measure': 'Fat Mass(FM)-For-age Z-score', 'timeFrame': '36 weeks or hospital discharge, up to 120 days following birth, whichever is longer', 'description': 'Estimated by air displacement plethysmography. FM measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019). A Z-score of 0 represents the population mean. Z-score values closer to 0 represent a better outcome. No relevant thresholds have been defined.'}, {'measure': 'Body Fat(BF)-For-age Z-score', 'timeFrame': '36 weeks or hospital discharge, up to 120 days following birth, whichever is longer', 'description': 'Body fat estimated by air displacement plethysmography. BF measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019). A Z-score of 0 represents the population mean. Z-score values closer to 0 represent a better outcome. No relevant thresholds have been defined.'}, {'measure': 'Anthropometric Measurements', 'timeFrame': 'Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first)', 'description': "Weight, length, and head circumference measurements. Measurements were converted into Z-scores based on Fenton growth curves (2013). They were calculated at birth and at 36 weeks. This outcome represents the change in weight, length, and head circumference Z-score during the course of the study (i.e., the Z-score at birth was subtracted from the Z-score at 36 weeks).\n\nA value of 0 represents that the infant's Z-score is the same at the beginning and the end of the study. Positive values indicate the increase in the infant's Z-score during the study; negative values indicate the decrease in the infant's Z-score during the study."}, {'measure': 'Growth Rate', 'timeFrame': 'Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first)', 'description': 'Weight gain in g/kg/day'}, {'measure': 'Number of Participants With Postnatal Growth Failure', 'timeFrame': '36 weeks or hospital discharge (whichever occurred first)', 'description': 'Diagnosis of growth failure (weight \\< 10th percentile using the 2013 Fenton growth curves)'}, {'measure': 'Number of Participants With Diagnosis of Necrotizing Enterocolitis', 'timeFrame': 'From birth up to 120 days following birth', 'description': 'Diagnosis of necrotizing enterocolitis stage 2 or 3'}, {'measure': 'Number of Participants With Diagnosis of Intestinal Perforation', 'timeFrame': 'From birth up to 120 days following birth', 'description': 'Diagnosis of intestinal perforation'}, {'measure': 'Death', 'timeFrame': 'Birth to 120 days', 'description': 'Death prior to 121 days of life'}, {'measure': 'Culture-proven Sepsis', 'timeFrame': 'Birth to 120 days', 'description': 'Diagnosis of sepsis with positive blood cultures'}, {'measure': 'Number of Days Alive and Receiving Full Enteral Feeding', 'timeFrame': 'Birth to 28 days', 'description': 'Time to full enteral feeding days'}, {'measure': 'Number of Episodes of Feeding Intolerance', 'timeFrame': 'Birth to 28 days', 'description': 'Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination'}, {'measure': 'Duration of Hospital Stay in Days', 'timeFrame': 'Birth to 120 days or discharge, whichever occurs first', 'description': 'From day of admission to day of hospital discharge to home'}, {'measure': 'Serum BUN', 'timeFrame': 'Birth to 28 days', 'description': 'Highest serum BUN value in the first 28 days after birth'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prematurity; Extreme', 'Feeding Disorder Neonatal', 'Breast Milk Expression', 'Growth Failure', 'Microbial Colonization']}, 'referencesModule': {'references': [{'pmid': '40714049', 'type': 'RESULT', 'citation': 'Tucker MJ, Jeffcoat SH, Argent T, Travers CP, Salas AA. Severity of Bronchopulmonary Dysplasia in Infants Born Extremely Preterm and Randomized to Early Human Milk Fortification with a Donor Milk-Derived Fortifier for 2 Weeks. J Pediatr. 2025 Dec;287:114750. doi: 10.1016/j.jpeds.2025.114750. Epub 2025 Jul 24.'}, {'pmid': '37551512', 'type': 'RESULT', 'citation': 'Salas AA, Gunawan E, Nguyen K, Reeves A, Argent V, Finck A, Carlo WA. Early Human Milk Fortification in Infants Born Extremely Preterm: A Randomized Trial. Pediatrics. 2023 Sep 1;152(3):e2023061603. doi: 10.1542/peds.2023-061603.'}]}, 'descriptionModule': {'briefSummary': 'The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z scores and promote maturation of the gut microbiome at term corrected age.', 'detailedDescription': 'Masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either a protein-enriched diet (intervention group) or a usual diet (control group) within the first 96 hours after birth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age ≤ 28 weeks of gestation\n* Postnatal age \\< 96 hours\n\nExclusion Criteria:\n\n* Congenital malformations\n* Chromosomal anomalies\n* Terminal illness needing to limit or withhold support'}, 'identificationModule': {'nctId': 'NCT04325308', 'briefTitle': 'Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Early Life Protein-enriched Human Milk Diets to Increase Lean Body Mass Accretion and Diversity of the Gut Microbiome in Extremely Preterm Infants: a Randomized Trial', 'orgStudyIdInfo': {'id': '300005089'}, 'secondaryIdInfos': [{'id': 'K23HD102554', 'link': 'https://reporter.nih.gov/quickSearch/K23HD102554', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Protein-enriched human milk diet', 'description': 'Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.', 'interventionNames': ['Procedure: Protein-enriched human milk diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual human milk diet', 'description': 'Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.', 'interventionNames': ['Procedure: Usual human milk diet']}], 'interventions': [{'name': 'Protein-enriched human milk diet', 'type': 'PROCEDURE', 'description': '1.2 g of human-based protein will be added to each 100 ml of human milk administered', 'armGroupLabels': ['Protein-enriched human milk diet']}, {'name': 'Usual human milk diet', 'type': 'PROCEDURE', 'description': 'Human-based protein will not be added to the human milk administered.', 'armGroupLabels': ['Usual human milk diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Ariel Salas, MD, MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ariel A. Salas', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}