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

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. Demographics, anthropometrics, and clinical outcomes were collected prospectively. Anthropometric z-scores were calculated using WHO standards. 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seven infants were randomized to EHM or control diet, with 23 infants meeting predefined exclusion criteria, 8 infants withdrawn/died, leaving 76 infants at discharge.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. 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. This trial is registered with ClinicalTrials.gov ( www.clinicaltrials.gov , Trial ID: NCT02860702). This trial was approved by the Institutional Review Board of the University of Texas Health Sciences Center at San Antonio (ID: HSC20150779H).