- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02657629
Comparison of Feeding Strategies for Hypoplastic Left Heart Syndrome Infants
Comparison of Feeding Strategies After Stage 1 Procedures for Hypoplastic Left Heart Syndrome Infants: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Continuous Feeding Regimen
Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight Gain in Grams Per Day
Time Frame: Daily until hospital discharge (up to maximum of 3 months of age)
|
Daily until hospital discharge (up to maximum of 3 months of age)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ganga Krishnamurthy, MD, Columbia University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAE0781
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Clinical Trials on Hypoplastic Left Heart Syndrome
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Mayo ClinicRecruitingHypoplastic Left Heart Syndrome (HLHS)United States
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Children's Hospital Medical Center, CincinnatiRecruitingHypoplastic Left Heart Syndrome (HLHS)United States, United Kingdom, Canada
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Emory UniversityCompleted
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Athena ZuppaCompletedHypoplastic Left Heart | Tetrology of Fallot | Heart VentricleUnited States
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HealthCore-NERISuspendedCongenital Heart Disease | Hypoplastic Left HeartUnited States, Canada
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Athena ZuppaCompletedTetralogy of Fallot | Tricuspid Atresia | Hypoplastic Left Heart
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Nationwide Children's HospitalNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health... and other collaboratorsRecruitingHeart Diseases | Cardiovascular Diseases | Heart Defects, Congenital | Cardiovascular Abnormalities | HLH - Hypoplastic Left Heart Syndrome | DORV | DILV - Double Inlet Left Ventricle | Mitral Atresia | Tricuspid Atresia | Unbalanced AV Canal | Single-ventricleUnited States
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Baylor College of MedicineCompletedCongenital Heart Disease | Cardiac Disease | Hypoplastic Left Heart | Cyanotic Congenital Heart DiseaseUnited States
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Okayama UniversityTranslational Research Center for Medical Innovation, Kobe, Hyogo, JapanCompletedHypoplastic Left Heart Syndrome | Single Right Ventricle | Single Left VentricleJapan
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Kevin HillCompletedHypoplastic Left Heart Syndrome | Hypoplastic Right-sided Heart ComplexUnited States
Clinical Trials on Continuous Feeding Regimen
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NestléCompletedGlucose, High Blood | Infant DevelopmentPhilippines
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Qingdao UniversityUnknownFeeding BehaviorChina
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NestléBiofortis Mérieux NutriSciencesCompleted
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Rambam Health Care CampusCompletedRespiratory Disease | Premature InfantIsrael
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National University Hospital, SingaporeUnknownBronchopulmonary Dysplasia | Chronic Lung Disease of PrematurityMalaysia, Singapore
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Chinese University of Hong KongCompletedAspiration PneumoniaChina
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Akron Children's HospitalCompletedDietary ModificationUnited States
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Xinhua Hospital, Shanghai Jiao Tong University...Children's Hospital of Fudan University; Shanghai Children's Hospital; Shanghai...UnknownEnteral Feeding | Ventilator-Associated Pneumonia
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University Hospitals of North Midlands NHS TrustWithdrawnStroke | DysphagiaUnited Kingdom
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Nanfang Hospital, Southern Medical UniversityCompletedObesity | Weight Loss | Time Restricted Feeding | Calorie RestrictionChina