N/A
N=28
Comparison of Feeding Strategies for Hypoplastic Left Heart Syndrome Infants
Hypoplastic Left Heart Syndrome · Growth Failure
Bottom Line
View on ClinicalTrials.gov: NCT02657629 ↗Enrolled (actual)
28
Serious AEs
11.5%
Results posted
Feb 2016
Primary outcome: Primary: Weight Gain in Grams Per Day — 24.3; 23.6 grams/day — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous Feeding Regimen (Other); Intermittent Bolus Feeding Regimen (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Gain in Grams Per Day |
24.3; 23.6 | 0.05 |
Summary
The purpose of the study is to determine if a continuous feeding regimen as compared to an intermittent bolus feeding regimen leads to improved weight gain in infants with hypoplastic left heart syndrome (HLHS) after stage 1 procedures.
Eligibility Criteria
Inclusion Criteria
- Subjects with HLHS/SVV who underwent stage 1 procedures (Norwood or Hybrid procedure) who were inborn or transferred into the Neonatal Intensive Care Unit at Columbia University Medical Center
Exclusion Criteria
- Excluded subjects were those with associated major congenital malformations (e.g. congenital diaphragmatic hernia, gastroschisis) or chromosomal anomalies, and/or those who were small for gestational age at birth.
- Subjects in whom a nasogastric tube or gastrostomy tube was not required for feeding at the time of enrollment and/or who were transferred to outside institutions for recovery after surgery.
Data sourced from ClinicalTrials.gov (NCT02657629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.