TY - JOUR
T1 - A Randomized Trial of an Exclusive Human Milk Diet in Neonates with Single Ventricle Physiology
AU - Cardiac Neonate Nutrition Study Group
AU - Blanco, Cynthia L.
AU - Hair, Amy
AU - Justice, Lindsey B.
AU - Roddy, Dantin
AU - Bonagurio, Krista
AU - Williams, Patricia K.
AU - Machado, Desiree
AU - Marino, Bradley S.
AU - Chi, Annie
AU - Takao, Cheryl
AU - Gordon, Erin E.
AU - Ashrafi, Amir
AU - Cacho, Nicole
AU - Pruetz, Jay D.
AU - Costello, John M.
AU - Cooper, David S.
N1 - Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2023/5
Y1 - 2023/5
N2 - 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).
AB - 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).
UR - http://www.scopus.com/inward/record.url?scp=85149885422&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85149885422&partnerID=8YFLogxK
U2 - 10.1016/j.jpeds.2022.11.043
DO - 10.1016/j.jpeds.2022.11.043
M3 - Article
C2 - 36528055
AN - SCOPUS:85149885422
SN - 0022-3476
VL - 256
SP - 105-112.e4
JO - Journal of Pediatrics
JF - Journal of Pediatrics
ER -