Comparison of Feeding Strategies for Hypoplastic Left Heart Syndrome Infants
|ClinicalTrials.gov Identifier: NCT02657629|
Recruitment Status : Completed
First Posted : January 18, 2016
Results First Posted : February 15, 2016
Last Update Posted : February 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hypoplastic Left Heart Syndrome Growth Failure||Other: Continuous Feeding Regimen Other: Intermittent Bolus Feeding Regimen||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Comparison of Feeding Strategies After Stage 1 Procedures for Hypoplastic Left Heart Syndrome Infants: A Randomized Controlled Trial|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Active Comparator: Continuous Feeding Regimen
Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.
Other: Continuous Feeding Regimen
Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d.
Active Comparator: Intermittent Bolus Feeding Regimen
Enteral feedings given as intermittent bolus feedings for entire 24 hour period.
Other: Intermittent Bolus Feeding Regimen
Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d.
- Weight Gain in Grams Per Day [ Time Frame: Daily until hospital discharge (up to maximum of 3 months of age) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657629
|Principal Investigator:||Ganga Krishnamurthy, MD||Columbia University|