Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-31 @ 11:02 PM
Study NCT ID:
NCT02632266
Status:
COMPLETED
Last Update Posted:
2020-09-03
First Post:
2015-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2015-12-10', 'studyFirstSubmitQcDate': '2015-12-11', 'lastUpdatePostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative weight gain', 'timeFrame': 'Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier', 'description': 'Weight gain of baby during the course of the study'}, {'measure': 'Change in weight', 'timeFrame': 'Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier', 'description': 'Weight gain of baby week-to-week, during the course of the study'}, {'measure': 'Linear length', 'timeFrame': 'Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier', 'description': 'change in length week-to-week during the course of the study'}, {'measure': 'Head growth', 'timeFrame': 'Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier', 'description': 'Change in head measurements week-to-week during the course of the study'}], 'secondaryOutcomes': [{'measure': 'Nutrition biomarkers', 'timeFrame': 'Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier', 'description': "Measurements of a baby's Ca, P, Mg, Alkaline Phosphatase and Prealbumin will be taken"}, {'measure': 'Tolerance to enteral feeds', 'timeFrame': 'Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier', 'description': 'number of significant residuals, number of times feeds were held, NEC'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prematurity', 'growth', 'nutrition', 'human milk fortifier'], 'conditions': ['Complication of Prematurity']}, 'referencesModule': {'references': [{'pmid': '9724686', 'type': 'RESULT', 'citation': 'Hylander MA, Strobino DM, Dhanireddy R. Human milk feedings and infection among very low birth weight infants. Pediatrics. 1998 Sep;102(3):E38. doi: 10.1542/peds.102.3.e38.'}, {'pmid': '1979363', 'type': 'RESULT', 'citation': 'Lucas A, Cole TJ. Breast milk and neonatal necrotising enterocolitis. Lancet. 1990 Dec 22-29;336(8730):1519-23. doi: 10.1016/0140-6736(90)93304-8.'}, {'pmid': '3373407', 'type': 'RESULT', 'citation': "Greer FR, McCormick A. Improved bone mineralization and growth in premature infants fed fortified own mother's milk. J Pediatr. 1988 Jun;112(6):961-9. doi: 10.1016/s0022-3476(88)80227-0."}, {'pmid': '25102321', 'type': 'RESULT', 'citation': 'Cibulskis CC, Armbrecht ES. Association of metabolic acidosis with bovine milk-based human milk fortifiers. J Perinatol. 2015 Feb;35(2):115-9. doi: 10.1038/jp.2014.143. Epub 2014 Aug 7.'}, {'pmid': '24394538', 'type': 'RESULT', 'citation': 'Thoene M, Hanson C, Lyden E, Dugick L, Ruybal L, Anderson-Berry A. Comparison of the effect of two human milk fortifiers on clinical outcomes in premature infants. Nutrients. 2014 Jan 3;6(1):261-75. doi: 10.3390/nu6010261.'}, {'pmid': '19881390', 'type': 'RESULT', 'citation': 'Agostoni C, Buonocore G, Carnielli VP, De Curtis M, Darmaun D, Decsi T, Domellof M, Embleton ND, Fusch C, Genzel-Boroviczeny O, Goulet O, Kalhan SC, Kolacek S, Koletzko B, Lapillonne A, Mihatsch W, Moreno L, Neu J, Poindexter B, Puntis J, Putet G, Rigo J, Riskin A, Salle B, Sauer P, Shamir R, Szajewska H, Thureen P, Turck D, van Goudoever JB, Ziegler EE; ESPGHAN Committee on Nutrition. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):85-91. doi: 10.1097/MPG.0b013e3181adaee0.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is for the researchers to examine the safety and efficacy of liquid human milk fortifier (HMF) in moderately preterm infants compared to powdered human milk fortifier.', 'detailedDescription': 'This is a prospective, randomize, double-blinded study in preterm infants born between 28-34 weeks gestation admitted to the NICU at the University of Kansas Hospital. After obtaining informed consent, babies will be randomized to either liquid or powdered HMF using opaque, sealed envelopes with preassigned randomization. The feeding protocol as established in the KU NICU will be followed, beginning with initiation of trophic feeds, and advancement of enteral feeds depending on the gestational age and preceding illnesses. Once infants reach 80ml/kg/day of enteral feeds, human milk will be fortified to 22 kilocalories by adding either liquid or powdered fortifier. The beginning of the study(Study day 1) will be defined as reaching and tolerating 100ml/kg/day of 24 kilocalorie human milk fortified with either liquid or powdered fortifier. Enteral feeds will be advanced per unit protocol until they reach 150-160ml/kg/day and 110-120 kcal/kg/day. the volume of feeds will be adjusted based on the documented weight to provide energy and protein requirements as recommended by the ESPGHAN guidelines. Babies will be followed up until the time of NICU discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '34 Weeks', 'minimumAge': '28 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Inborn preterm infants born between 28 0/7 and 34 0/7 weeks gestation and fed either mother's own milk or donor human milk\n\nExclusion Criteria:\n\n* Newborn infants \\<28 weeks and \\>34 weeks gestation, those with life threatening illness, congenital and chromosomal anomalies, gastrointestinal anomalies or necrotizing enterocolitis and fed premature formula"}, 'identificationModule': {'nctId': 'NCT02632266', 'briefTitle': 'Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants', 'orgStudyIdInfo': {'id': 'STUDY00002292'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Powder HMF', 'description': 'Once patient has reached 80ml/kg/day of enteral feedings, 1 pack of powder HMF will be added to 50 ml of human or donor breast milk, then increased to a maximum of 2 packs for 50 ml following the unit feeding advancement protocol and this will be continued up until 48 hours prior to discharge.', 'interventionNames': ['Dietary Supplement: Powder HMF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Liquid HMF', 'description': 'Once patient has reached 80ml/kg/day of enteral feedings, researchers will add 1 packet (5 ml) of liquid HMF to 50 ml of human or donor breast milk, then increase to 2 packs to 50 ml following the unit feeding protocol and this will be continued up until 48 hours prior to discharge.', 'interventionNames': ['Dietary Supplement: Liquid HMF']}], 'interventions': [{'name': 'Powder HMF', 'type': 'DIETARY_SUPPLEMENT', 'description': 'powder human milk fortifier', 'armGroupLabels': ['Powder HMF']}, {'name': 'Liquid HMF', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Liquid human milk fortifier', 'armGroupLabels': ['Liquid HMF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Vishal Pandey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}