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A Randomized Trial of an Exclusive Human Milk Diet in Neonates with Single Ventricle Physiology
Cynthia L Blanco1, Amy Hair2, Lindsey B Justice3
1Division of Neonatology, Department of Pediatrics, University of Texas Health Science Center and University Health, San Antonio, TX.
Insights
Exclusive human milk diets improve weight gain and reduce necrotizing enterocolitis (NEC) in infants with single ventricle physiology after cardiac surgery. This supports better short-term growth and outcomes for these vulnerable neonates.
Area of Science:
- Neonatal nutrition
- Pediatric cardiology
- Surgical outcomes
Background:
- Infants with single ventricle physiology often require cardiac surgery and specialized feeding.
- Optimizing nutrition is critical for growth and reducing complications in these neonates.
Purpose of the Study:
- To compare the effects of an exclusive human milk diet versus a mixed diet on weight gain velocity and clinical outcomes in neonates with single ventricle physiology after cardiac surgery.
- To assess the impact of diet on short-term growth and morbidities such as necrotizing enterocolitis (NEC).
Main Methods:
- A multicenter, randomized, single-blinded, controlled trial involving 107 neonates undergoing cardiac surgery.
- Infants received either an exclusive human milk diet with human milk-based fortifier or a mixed diet with standard formula fortification.
- Weight gain velocity and clinical outcomes were monitored for 30 days post-initiation of feeds.
Main Results:
- Higher median weight gain velocity was observed in the exclusive human milk group (12 g/day) compared to the control group (8 g/day) (P=.03).
- Necrotizing enterocolitis (NEC) occurred significantly less frequently in the exclusive human milk group (3.6%) versus the control group (15.4%) (P=.04).
- Other growth measures, major morbidities, surgical complications, length of stay, and mortality were similar between groups.
Conclusions:
- An exclusive human milk diet promotes improved short-term growth in neonates with single ventricle physiology after stage 1 surgical palliation.
- Exclusive human milk feeding is associated with a decreased risk of NEC in this vulnerable population.
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).
