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Comparison of Feeding Strategies for Hypoplastic Left Heart Syndrome Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02657629
Recruitment Status : Completed
First Posted : January 18, 2016
Results First Posted : February 15, 2016
Last Update Posted : February 15, 2016
Information provided by (Responsible Party):
Nicole Spillane, 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.

Condition or disease Intervention/treatment Phase
Hypoplastic Left Heart Syndrome Growth Failure Other: Continuous Feeding Regimen Other: Intermittent Bolus Feeding Regimen Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Weight Gain in Grams Per Day [ Time Frame: Daily until hospital discharge (up to maximum of 3 months of age) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02657629

Sponsors and Collaborators
Columbia University
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Principal Investigator: Ganga Krishnamurthy, MD Columbia University
Publications of Results:
Other Publications:
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Responsible Party: Nicole Spillane, Pediatric Fellow, Columbia University Identifier: NCT02657629    
Other Study ID Numbers: AAAE0781
First Posted: January 18, 2016    Key Record Dates
Results First Posted: February 15, 2016
Last Update Posted: February 15, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Hypoplastic Left Heart Syndrome
Failure to Thrive
Pathologic Processes
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities