Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Feeding Regimen | Active Comparator | Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings. |
|
| Intermittent Bolus Feeding Regimen | Active Comparator | Enteral feedings given as intermittent bolus feedings for entire 24 hour period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Feeding Regimen | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain in Grams Per Day | Daily until hospital discharge (up to maximum of 3 months of age) |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ganga Krishnamurthy, MD | Columbia University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22891735 | Background | 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. | |
| 22572758 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Feeding Regimen | Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings. 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. |
| FG001 | Intermittent Bolus Feeding Regimen | Enteral feedings given as intermittent bolus feedings for entire 24 hour period. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Feeding Regimen | Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Gain in Grams Per Day | Posted | Mean | Standard Deviation | grams/day | Daily until hospital discharge (up to maximum of 3 months of age) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continuous Feeding Regimen | Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| necrotizing enterocolitis | Gastrointestinal disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Spillane MD | HackensackUMC | 917-446-6656 | nspillane@hackensackumc.org |
Not provided
| ID | Term |
|---|---|
| D018636 | Hypoplastic Left Heart Syndrome |
| D005183 | Failure to Thrive |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Intermittent Bolus Feeding Regimen | Other | 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. |
|
| Result |
| 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. |
| 1904091 | Result | 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. |
| 3108622 | Result | 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. |
| 22939929 | Result | 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. |
| 22152530 | Result | 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. |
| BG001 | Intermittent Bolus Feeding Regimen | Enteral feedings given as intermittent bolus feedings for entire 24 hour period. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | gestational age in weeks at birth |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| 1 |
| 12 |
| 0 |
| 12 |
| EG001 | Intermittent Bolus Feeding Regimen | Enteral feedings given as intermittent bolus feedings for entire 24 hour period. 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. | 2 | 14 | 0 | 14 |
| aspiration | Respiratory, thoracic and mediastinal disorders |
|
Not provided
Not provided
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |