A Randomized Trial of an Exclusive Human Milk Diet in Neonates with Single Ventricle Physiology - 05/05/23
, Amy Hair, MD 2, Lindsey B. Justice, DNP 3, Dantin Roddy, MD 4, Krista Bonagurio, RD 1, Patricia K. Williams, MD 5, Desiree Machado, MD 6, Bradley S. Marino, MD 7, 8, Annie Chi, MD 9, Cheryl Takao, MD 10, Erin E. Gordon, DO 11, Amir Ashrafi, MD 12, Nicole Cacho, DO, MPH 13, Jay D. Pruetz, MD 10, John M. Costello, MD, MPH 7, 14, David S. Cooper, MD, MPH 15on behalf of the
Cardiac Neonate Nutrition Study Group∗
Abstract |
Objective |
To determine whether weight gain velocity (g/kg/day) 30 days after the initiation of feeds after cardiac surgery and other clinical outcomes improve in infants with single ventricle physiology fed an exclusive human milk diet compared with a mixed human and bovine diet.
Study design |
In this multicenter, randomized, single blinded, controlled trial, term neonates 7 days of age or younger with single ventricle physiology and anticipated cardiac surgical palliation within 30 days of birth were enrolled at 10 US centers. Both groups received human milk if fed preoperatively. During the 30 days after feeds were started postoperatively, infants in the intervention group received human milk fortified once enteral intake reached 60 mL/kg/day with a human milk-based fortifier designed for term neonates. The control group received standard fortification with formula once enteral intake reached 100 mL/kg/day. Perioperative feeding and parenteral nutrition study algorithms were followed.
Results |
We enrolled 107 neonates (exclusive human milk = 55, control = 52). Baseline demographics and characteristics were similar between the groups. The median weight gain velocity at study completion was higher in exclusive human milk vs control group (12 g/day [IQR, 5-18 g/day] vs 8 g/day [IQR, 0.4-14 g/day], respectively; P = .03). Other growth measures were similar between groups. Necrotizing enterocolitis of all Bell stages was higher in the control group (15.4 % vs 3.6%, respectively; P = .04). The incidence of other major morbidities, surgical complications, length of hospital stay, and hospital mortality were similar between the groups.
Conclusions |
Neonates with single ventricle physiology have improved short-term growth and decreased risk of NEC when receiving an exclusive human milk diet after stage 1 surgical palliation.
Trial Registration |
This trial is registered with ClinicalTrials.gov (www.clinicaltrials.gov, Trial ID: NCT02860702).
Le texte complet de cet article est disponible en PDF.Abbreviations : CHD, FOC, NEC, NPO, TPN
Plan
| Funding was provided by Prolacta Bioscience, CA. No individuals contracted or employed by the funders played any role in study design, decision to publish, or preparation of the manuscript. |
|
| All authors received research support from Prolacta Bioscience. |
Vol 256
P. 105 - mai 2023 Retour au numéro
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