Journal article
Neurodevelopmental Outcomes of Extremely Preterm Infants Fed Donor Milk or Preterm Infant Formula: A Randomized Clinical Trial
JAMA : the journal of the American Medical Association, Vol.331(7), pp.582-591
02/20/2024
DOI: 10.1001/jama.2023.27693
PMCID: PMC10828950
PMID: 38497706
Abstract
Maternal milk feeding of extremely preterm infants during the birth hospitalization has been associated with better neurodevelopmental outcomes compared with preterm formula. For infants receiving no or minimal maternal milk, it is unknown whether donor human milk conveys similar neurodevelopmental advantages vs preterm formula.
To determine if nutrient-fortified, pasteurized donor human milk improves neurodevelopmental outcomes at 22 to 26 months' corrected age compared with preterm infant formula among extremely preterm infants who received minimal maternal milk.
Double-blind, randomized clinical trial conducted at 15 US academic medical centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Infants younger than 29 weeks 0 days' gestation or with a birth weight of less than 1000 g were enrolled between September 2012 and March 2019.
Preterm formula or donor human milk feeding from randomization to 120 days of age, death, or hospital discharge.
The primary outcome was the Bayley Scales of Infant and Toddler Development (BSID) cognitive score measured at 22 to 26 months' corrected age; a score of 54 (score range, 54-155; a score of ≥85 indicates no neurodevelopmental delay) was assigned to infants who died between randomization and 22 to 26 months' corrected age. The 24 secondary outcomes included BSID language and motor scores, in-hospital growth, necrotizing enterocolitis, and death.
Of 1965 eligible infants, 483 were randomized (239 in the donor milk group and 244 in the preterm formula group); the median gestational age was 26 weeks (IQR, 25-27 weeks), the median birth weight was 840 g (IQR, 676-986 g), and 52% were female. The birthing parent's race was self-reported as Black for 52% (247/478), White for 43% (206/478), and other for 5% (25/478). There were 54 infants who died prior to follow-up; 88% (376/429) of survivors were assessed at 22 to 26 months' corrected age. The adjusted mean BSID cognitive score was 80.7 (SD, 17.4) for the donor milk group vs 81.1 (SD, 16.7) for the preterm formula group (adjusted mean difference, -0.77 [95% CI, -3.93 to 2.39], which was not significant); the adjusted mean BSID language and motor scores also did not differ. Mortality (death prior to follow-up) was 13% (29/231) in the donor milk group vs 11% (25/233) in the preterm formula group (adjusted risk difference, -1% [95% CI, -4% to 2%]). Necrotizing enterocolitis occurred in 4.2% of infants (10/239) in the donor milk group vs 9.0% of infants (22/244) in the preterm formula group (adjusted risk difference, -5% [95% CI, -9% to -2%]). Weight gain was slower in the donor milk group (22.3 g/kg/d [95% CI, 21.3 to 23.3 g/kg/d]) compared with the preterm formula group (24.6 g/kg/d [95% CI, 23.6 to 25.6 g/kg/d]).
Among extremely preterm neonates fed minimal maternal milk, neurodevelopmental outcomes at 22 to 26 months' corrected age did not differ between infants fed donor milk or preterm formula.
ClinicalTrials.gov Identifier: NCT01534481.
Details
- Title: Subtitle
- Neurodevelopmental Outcomes of Extremely Preterm Infants Fed Donor Milk or Preterm Infant Formula: A Randomized Clinical Trial
- Creators
- Tarah T Colaizy - University of Iowa, NeonatologyBrenda B Poindexter - University of CincinnatiScott A McDonald - RTI InternationalEdward F Bell - University of Iowa, NeonatologyWaldemar A Carlo - University of AlabamaSusan J Carlson - University of IowaSara B DeMauro - University of PennsylvaniaKathleen A Kennedy - The University of Texas Health Science Center at HoustonLeif D Nelin - Nationwide Children's HospitalPablo J Sánchez - Nationwide Children's HospitalBetty R Vohr - Brown UniversityKaren J Johnson - University of IowaDianne E Herron - Indiana UniversityAbhik Das - RTI InternationalMargaret M Crawford - RTI InternationalMichele C Walsh - Eunice Kennedy Shriver National Institute of Child Health and Human DevelopmentRosemary D Higgins - Eunice Kennedy Shriver National Institute of Child Health and Human DevelopmentBarbara J Stoll - The University of Texas Health Science Center at HoustonNamisavayam Ambalavanan - University of AlabamaMyra H Wyckoff - Southwestern Medical CenterCarl T D'Angio - University of RochesterGeorge W Bugg - Children's Healthcare of AtlantaRobin K Ohls - University of New MexicoAnne Marie Reynolds - Women & Children's Hospital of BuffaloGregory M Sokol - Indiana UniversityAbbot R Laptook - Brown UniversitySteven L Olsen - Children's Mercy HospitalJessica R White - University of South DakotaSudarshan R Jadcherla - Nationwide Children's HospitalMonika Bajaj - Wayne State UniversityPrabhu S Parimi - University of Kansas Medical CenterBarbara Schmidt - University of PennsylvaniaMatthew M Laughon - University of North Carolina at Chapel HillJohn Barks - C. S. Mott Children's HospitalKimberley A Fisher - Duke UniversityAnna Maria Hibbs - Case Western Reserve UniversityMyriam Peralta-Carcelen - University of AlabamaNoah Cook - Pennsylvania HospitalRoy J Heyne - The University of Texas Southwestern Medical CenterBrenna Cavanaugh - University of RochesterIra Adams-Chapman - Emory UniversityJanell Fuller - University of New MexicoMichelle E Hartley-McAndrew - University at Buffalo, State University of New YorkHeidi M Harmon - University of Iowa, NeonatologyAndrea F Duncan - University of PennsylvaniaAbbey C Hines - Riley Hospital for ChildrenHoward W Kilbride - Children's Mercy HospitalLaurie A Richards - University of South DakotaNathalie L Maitre - Nationwide Children's HospitalGirija Natarajan - Wayne State UniversityAndrea N Trembath - University of North Carolina at Chapel HillMartha D Carlson - University of MichiganWilliam F Malcolm - Duke UniversityDeanne E Wilson-Costello - Case Western Reserve UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network
- Resource Type
- Journal article
- Publication Details
- JAMA : the journal of the American Medical Association, Vol.331(7), pp.582-591
- DOI
- 10.1001/jama.2023.27693
- PMID
- 38497706
- PMCID
- PMC10828950
- NLM abbreviation
- JAMA
- ISSN
- 0098-7484
- eISSN
- 1538-3598
- Grant note
- UG1 HD068244 / NICHD NIH HHS UG1 HD021385 / NICHD NIH HHS UG1 HD040492 / NICHD NIH HHS UG1 HD027851 / NICHD NIH HHS UG1 HD053089 / NICHD NIH HHS UG1 HD087226 / NICHD NIH HHS UG1 HD027904 / NICHD NIH HHS U24 HD095254 / NICHD NIH HHS UG1 HD068284 / NICHD NIH HHS UG1 HD068270 / NICHD NIH HHS
- Language
- English
- Date published
- 02/20/2024
- Academic Unit
- Stead Family Department of Pediatrics; Neonatology
- Record Identifier
- 9984549759502771
Metrics
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