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Comparison of Feeding Strategies for Hypoplastic Left Heart Syndrome Infants

Primary Purpose

Hypoplastic Left Heart Syndrome, Growth Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous Feeding Regimen
Intermittent Bolus Feeding Regimen
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypoplastic Left Heart Syndrome

Eligibility Criteria

undefined - 3 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Continuous Feeding Regimen

    Intermittent Bolus Feeding Regimen

    Arm Description

    Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.

    Enteral feedings given as intermittent bolus feedings for entire 24 hour period.

    Outcomes

    Primary Outcome Measures

    Weight Gain in Grams Per Day

    Secondary Outcome Measures

    Full Information

    First Posted
    January 14, 2016
    Last Updated
    January 19, 2016
    Sponsor
    Columbia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02657629
    Brief Title
    Comparison of Feeding Strategies for Hypoplastic Left Heart Syndrome Infants
    Official Title
    Comparison of Feeding Strategies After Stage 1 Procedures for Hypoplastic Left Heart Syndrome Infants: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2009 (undefined)
    Primary Completion Date
    November 2012 (Actual)
    Study Completion Date
    November 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Columbia University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypoplastic Left Heart Syndrome, Growth Failure

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Continuous Feeding Regimen
    Arm Type
    Active Comparator
    Arm Description
    Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.
    Arm Title
    Intermittent Bolus Feeding Regimen
    Arm Type
    Active Comparator
    Arm Description
    Enteral feedings given as intermittent bolus feedings for entire 24 hour period.
    Intervention Type
    Other
    Intervention Name(s)
    Continuous Feeding Regimen
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Intermittent Bolus Feeding Regimen
    Intervention Description
    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 Measure Information:
    Title
    Weight Gain in Grams Per Day
    Time Frame
    Daily until hospital discharge (up to maximum of 3 months of age)

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    3 Months
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ganga Krishnamurthy, MD
    Organizational Affiliation
    Columbia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22891735
    Citation
    Slicker J, Hehir DA, Horsley M, Monczka J, Stern KW, Roman B, Ocampo EC, Flanagan L, Keenan E, Lambert LM, Davis D, Lamonica M, Rollison N, Heydarian H, Anderson JB; Feeding Work Group of the National Pediatric Cardiology Quality Improvement Collaborative. Nutrition algorithms for infants with hypoplastic left heart syndrome; birth through the first interstage period. Congenit Heart Dis. 2013 Mar-Apr;8(2):89-102. doi: 10.1111/j.1747-0803.2012.00705.x. Epub 2012 Aug 14.
    Results Reference
    background
    PubMed Identifier
    22572758
    Citation
    Wolovits JS, Torzone A. Feeding and nutritional challenges in infants with single ventricle physiology. Curr Opin Pediatr. 2012 Jun;24(3):295-300. doi: 10.1097/MOP.0b013e32835356ae.
    Results Reference
    result
    PubMed Identifier
    1904091
    Citation
    Grant J, Denne SC. Effect of intermittent versus continuous enteral feeding on energy expenditure in premature infants. J Pediatr. 1991 Jun;118(6):928-32. doi: 10.1016/s0022-3476(05)82213-9.
    Results Reference
    result
    PubMed Identifier
    3108622
    Citation
    Heymsfield SB, Casper K, Grossman GD. Bioenergetic and metabolic response to continuous v intermittent nasoenteric feeding. Metabolism. 1987 Jun;36(6):570-5. doi: 10.1016/0026-0495(87)90169-7.
    Results Reference
    result
    PubMed Identifier
    22939929
    Citation
    Ravishankar C, Zak V, Williams IA, Bellinger DC, Gaynor JW, Ghanayem NS, Krawczeski CD, Licht DJ, Mahony L, Newburger JW, Pemberton VL, Williams RV, Sananes R, Cook AL, Atz T, Khaikin S, Hsu DT; Pediatric Heart Network Investigators. Association of impaired linear growth and worse neurodevelopmental outcome in infants with single ventricle physiology: a report from the pediatric heart network infant single ventricle trial. J Pediatr. 2013 Feb;162(2):250-6.e2. doi: 10.1016/j.jpeds.2012.07.048. Epub 2012 Aug 30.
    Results Reference
    result
    PubMed Identifier
    22152530
    Citation
    Hehir DA, Cooper DS, Walters EM, Ghanayem NS. Feeding, growth, nutrition, and optimal interstage surveillance for infants with hypoplastic left heart syndrome. Cardiol Young. 2011 Dec;21 Suppl 2:59-64. doi: 10.1017/S1047951111001600.
    Results Reference
    result

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    Comparison of Feeding Strategies for Hypoplastic Left Heart Syndrome Infants

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