Growth Failure, Hypoplastic Left Heart Syndrome
Conditions
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.
Interventions
OTHERContinuous 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.
OTHERIntermittent 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.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Months
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight Gain in Grams Per Day | Daily until hospital discharge (up to maximum of 3 months of age) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 14 |
| Total | 26 |
Baseline characteristics
| Characteristic | Intermittent Bolus Feeding Regimen | Total | Continuous Feeding Regimen |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 26 Participants | 12 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 38.9 gestational age in weeks at birth STANDARD_DEVIATION 1.5 | 38.6 gestational age in weeks at birth STANDARD_DEVIATION 1.3 | 38.3 gestational age in weeks at birth STANDARD_DEVIATION 1 |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 12 Participants | 19 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 14 |
| serious Total, serious adverse events | 1 / 12 | 2 / 14 |
Outcome results
Primary
Weight Gain in Grams Per Day
Time frame: Daily until hospital discharge (up to maximum of 3 months of age)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Feeding Regimen | Weight Gain in Grams Per Day | 24.3 grams/day | Standard Deviation 14.6 |
| Intermittent Bolus Feeding Regimen | Weight Gain in Grams Per Day | 23.6 grams/day | Standard Deviation 7.7 |
p-value: 0.05t-test, 2 sided