ArticlePediatric research2026
A randomized trial of an exclusive human milk diet in neonates with single-ventricle physiology: 3 and 6 months follow-up outcomes.
Article in Pediatric research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02860702 (A Randomized Controlled Trial to Evaluate Growth Velocity and Clinical Outcomes of Infants With Single Ventricle Physiology Fed an Exclusive Human Milk Diet With Early Nutritional Fortification Following Surgical Repair), which is not on this map. Not yet cited in PubMed.
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A Randomized Controlled Trial to Evaluate Growth Velocity and Clinical Outcomes of Infants With Single Ventricle Physiology Fed an Exclusive Human Milk Diet With Early Nutritional Fortification Following Surgical Repair
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7 authors.
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Abstract
backgroundA 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.
methodsDemographics, anthropometrics, and clinical outcomes were collected prospectively. Anthropometric z-scores were calculated using WHO standards.
resultsOne 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seven infants were randomized to EHM or control diet, with 23 infants meeting predefined exclusion criteria, 8 infants withdrawn/died, leaving 76 infants at discharge.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.
conclusionsNeonates 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 registrationThis 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.
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