Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-05 @ 5:21 PM
Study NCT ID:
NCT02377050
Status:
COMPLETED
Last Update Posted:
2018-06-18
First Post:
2014-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-14', 'studyFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2015-02-24', 'lastUpdatePostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Body fat composition', 'timeFrame': '36 weeks or discharge', 'description': 'Percentage of body fat composition'}, {'measure': 'Rates of necrotizing enterocolitis (Bell Stage ≥ 2)', 'timeFrame': '36 weeks or discharge', 'description': 'Safety outcome: Rates of necrotizing enterocolitis (Bell Stage ≥ 2)'}, {'measure': 'Rates of feeding intolerance', 'timeFrame': '36 weeks or discharge', 'description': 'Safety outcome: Rates of feeding intolerance defined as withholding feeds for \\> 24 hours due to gastrointestinal cause after study entry'}, {'measure': 'Rates of culture proven sepsis', 'timeFrame': '36 weeks or discharge', 'description': 'Safety outcome: Rates of blood culture positive sepsis after study entry'}, {'measure': 'Duration of respiratory support', 'timeFrame': '36 weeks or discharge', 'description': 'Safety outcome: Duration of respiratory support (oxygen, continuous positive airway pressure/high flow nasal cannula/mechanical ventilation) after study entry'}, {'measure': 'Rates of bronchopulmonary dysplasia', 'timeFrame': '36 weeks or discharge', 'description': 'Safety outcome: Rates of bronchopulmonary dysplasia'}, {'measure': 'Rates of moderate to large or symptomatic patent ductus arteriosus', 'timeFrame': '36 weeks or discharge', 'description': 'Safety outcome: Rates of moderate to large or symptomatic patent ductus arteriosus after study entry'}, {'measure': 'Rates of adverse safety outcomes combined', 'timeFrame': '36 weeks or discharge', 'description': 'Safety outcome: Safety outcome: Rates of bronchopulmonary dysplasia, necrotizing enterocolitis ≥ stage 2, feeding intolerance, culture proven sepsis, patent ductus arteriosus after study entry'}], 'primaryOutcomes': [{'measure': 'Weight gain', 'timeFrame': 'baseline to average 12 weeks of age', 'description': 'Average change in weight between baseline and 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Mid arm circumference', 'timeFrame': 'baseline to average 12 weeks of age', 'description': 'average change in mid arm circumference between baseline and 12 weeks'}, {'measure': 'Length', 'timeFrame': 'baseline to average 12 weeks of age', 'description': 'average change in length between baseline and 12 weeks'}, {'measure': 'Head circumference', 'timeFrame': 'baseline to average 12 weeks of age', 'description': 'average change in head circumference between baseline and 12 weeks'}, {'measure': 'Caloric intake', 'timeFrame': '36 weeks', 'description': 'Average difference in weekly caloric intake between groups'}, {'measure': 'Length of stay', 'timeFrame': '36 weeks or discharge', 'description': 'Days from study entry to discharge home'}, {'measure': 'Rates of infants less than 10th percentile for weight', 'timeFrame': '36 weeks or discharge', 'description': 'Rates of infants less than 10th percentile for weight at study completion'}, {'measure': 'Change in weight z score', 'timeFrame': '36 weeks or discharge', 'description': 'Change in weight z score from study entry to completion'}, {'measure': 'Change in length z score', 'timeFrame': '36 weeks or discharge', 'description': 'Change in length z score from study entry to completion'}, {'measure': 'Change in head circumference z score', 'timeFrame': '36 weeks or discharge', 'description': 'Change in head circumference z score from study entry to completion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nutritional support'], 'conditions': ['Infant Premature']}, 'referencesModule': {'references': [{'pmid': '33248115', 'type': 'DERIVED', 'citation': 'Salas AA, Travers CP, Jerome ML, Chandler-Laney P, Carlo WA. Percent Body Fat Content Measured by Plethysmography in Infants Randomized to High- or Usual-Volume Feeding after Very Preterm Birth. J Pediatr. 2021 Mar;230:251-254.e3. doi: 10.1016/j.jpeds.2020.11.028. Epub 2020 Nov 25.'}, {'pmid': '32464224', 'type': 'DERIVED', 'citation': 'Travers CP, Wang T, Salas AA, Schofield E, Dills M, Laney D, Yee A, Bhatia A, Winter L, Ambalavanan N, Carlo WA. Higher- or Usual-Volume Feedings in Infants Born Very Preterm: A Randomized Clinical Trial. J Pediatr. 2020 Sep;224:66-71.e1. doi: 10.1016/j.jpeds.2020.05.033. Epub 2020 May 25.'}]}, 'descriptionModule': {'briefSummary': 'The primary hypothesis is that preterm infants who are less than or equal to 32 weeks gestation and weigh 1001-2500 grams at birth will have an increase in weight gain with a feeding goal of 180-200 ml/kg/day more than the commonly used feeding goal of 140-160 ml/kg/day', 'detailedDescription': 'The proposed trial is designed to test the primary hypothesis that in preterm infants weighing 1001-2500 grams at birth and who are less than or equal to 32 weeks gestation, feeding goals of 180-200 ml/kg/day will increase weight gain (g/k/day) from time of enrollment to discharge home or 36 weeks post-menstrual age (PMA)(whichever comes first) more than the commonly used feeding goal volume of 140-160 ml/kg/day (usual feeding goal). This is a pilot study to determine the safety of increased volumes of feedings as opposed to fortification of feedings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inborn or outborn infants born at a gestational age of 32 weeks or less; Birthweight 1001-2500; Feeding volume of at least 120 ml/kg/day; Enrolled prior to 28 days of age and prior to exceeding 32 weeks\n\nExclusion Criteria:\n\n* Hemodynamically significant patent ductus arteriosis; History of necrotizing enterocolitis Bell Stage II or greater; Known gastrointestinal or neurologic malformations; Prior or planned enrollment into the NICHD MILK Trial; Terminal illness or decision to withhold or limit support'}, 'identificationModule': {'nctId': 'NCT02377050', 'briefTitle': 'Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates', 'orgStudyIdInfo': {'id': 'UAB NEO 013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Higher Volume Feeding Goal', 'description': 'Infants randomized to this group will have higher volume feeding goals of 180-200 ml/kg/day.', 'interventionNames': ['Other: Higher Volume Feeding Goal']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Volume Feeding Goal', 'description': 'Infants randomized to this group will have feeding goals of 140-160 ml/kg/day.'}], 'interventions': [{'name': 'Higher Volume Feeding Goal', 'type': 'OTHER', 'description': 'feeding volume goal of 180-200 ml/kg/day', 'armGroupLabels': ['Higher Volume Feeding Goal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Waldemar A Carlo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Colm Travers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Ariel A Salas, MD', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Colm Travers', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}