A randomized trial of an exclusive human milk diet in neonates with single-ventricle physiology: 3 and 6 months follow-up outcomes

BACKGROUND: A prospective randomized controlled trial of exclusive human milk nutrition (EHM) in infants with single-ventricle physiology (SVP) was previously published. This study evaluates growth and health outcomes at 3-6 months. METHODS: Demographics, anthropometrics, and clinical outcomes were collected prospectively. Anthropometric z-scores were calculated using WHO standards. RESULTS: One hundred seven infants were randomized to EHM or control diet, with 23 infants meeting predefined exclusion criteria, 8 infants withdrawn/died, leaving 76 infants at discharge. At 3-6 months, 74 infants completed follow-up. Infants with hypoplastic left heart syndrome (HLHS) were similar (control 73%, EHM 86.5%; p = 0.24). Growth, z-scores, and hospitalization did not differ between groups up to 6 months. Median growth velocity was 25 (IQR: 20.24-30.99) and 22 (IQR: 18.76-23.94) g/day from birth to 3-6 months. Overall, 50-60% of infants achieved 100% PO intake by 3-6 months of age. CONCLUSIONS: Neonates with SVP receiving an EHM diet from birth to 30 days post-surgery had similar growth at 3-6 months of age compared to the control diet. Infants with SVP benefit from a protocolized nutritional approach, as evidenced by normal growth velocities in infancy. Centers may consider delaying gastrostomy tube placement until after the Glenn operation. TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov ( www. CLINICALTRIALS: gov , Trial ID: NCT02860702). IRB APPROVAL: This trial was approved by the Institutional Review Board of the University of Texas Health Sciences Center at San Antonio (ID: HSC20150779H). IMPACT: This multicenter RCT demonstrates the long-term benefits of exclusive human milk nutrition in infants with SVP, with improved growth and reduced necrotizing enterocolitis. A multidisciplinary approach and a well-thought-out nutritional algorithm can optimize growth in infants with complex congenital heart disease, similar to healthy term infants up to 6 months of age. The majority of infants with SVP requiring an operation within the first month of life are able to achieve 100% of their intake via PO by 6 months of age; therefore, delaying gastrostomy tube placement until after the Glenn operation may be considered.