Comparison of Feeding Strategies for Hypoplastic Left Heart Syndrome Infants

Not Applicable

Completed

• Conditions: Growth Failure; Hypoplastic Left Heart Syndrome
• Interventions: Other: Continuous Feeding Regimen; Other: Intermittent Bolus Feeding Regimen

• Registration Number: NCT02657629
• Lead Sponsor: Columbia University

Brief 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.

Detailed Description

In recent years, survival after neonatal cardiac surgery has improved significantly. As life span has improved in HLHS/single ventricle variants (SVV) survivors, focus has shifted to the understanding and management of associated health problems. Growth failure is a well-recognized major co-morbidity in these patients.

Infants with HLHS/SVV demonstrate progressive growth failure after stage 1 procedures, which appears to stabilize only after stage 2 procedures. Poor nutritional status increases risk for post-operative infections, extends hospital length-of-stay, and adversely affects neurodevelopmental outcomes.

To date, evidence-based feeding strategies that support adequate weight gain and improve nutritional status have not been identified after stage 1 procedures. Continuous enteral feeding regimens have resulted in improved growth in a diverse population of infants with congenital heart disease and have been shown to decrease energy expenditure in premature infants and adults. A randomized, controlled study of HLHS/SVV infants who underwent stage 1 procedures at a single medical center was conducted with the primary objective of comparing weight gain at hospital discharge between infants receiving a continuous feeding regimen versus an intermittent feeding regimen. Secondary objectives were to compare growth and markers of nutritional status at hospital discharge between the two groups. The investigators hypothesized that infants with HLHS/SVV who receive a continuous enteral feeding regimen versus an intermittent feeding regimen will demonstrate improved weight gain, growth, and nutritional status after stage 1 procedures at hospital discharge.

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2016-01
• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-15
• Study First Posted: 2016-01-18
• Results First Submitted: 2016-01-19
• Results First Submitted QC: 2016-01-19
• Last Update Submitted: 2016-01-19
• Results First Posted: 2016-02-15
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Feeding Regimen	Continuous Feeding Regimen	Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.
Intermittent Bolus Feeding Regimen	Intermittent Bolus Feeding Regimen	Enteral feedings given as intermittent bolus feedings for entire 24 hour period.

Primary Outcome Measures

Name	Time	Method
Weight Gain in Grams Per Day	Daily until hospital discharge (up to maximum of 3 months of age)