Trial Outcomes & Findings for Comparison of Feeding Strategies for Hypoplastic Left Heart Syndrome Infants (NCT NCT02657629)
NCT ID: NCT02657629
Last Updated: 2016-02-15
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Daily until hospital discharge (up to maximum of 3 months of age)
Results posted on
2016-02-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Feeding Strategies for Hypoplastic Left Heart Syndrome Infants
Baseline characteristics by cohort
| Measure |
Continuous Feeding Regimen
n=12 Participants
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.
|
Intermittent Bolus Feeding Regimen
n=14 Participants
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.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.3 gestational age in weeks at birth
STANDARD_DEVIATION 1 • n=5 Participants
|
38.9 gestational age in weeks at birth
STANDARD_DEVIATION 1.5 • n=7 Participants
|
38.6 gestational age in weeks at birth
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Daily until hospital discharge (up to maximum of 3 months of age)Outcome measures
| Measure |
Continuous Feeding Regimen
n=12 Participants
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.
|
Intermittent Bolus Feeding Regimen
n=14 Participants
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.
|
|---|---|---|
|
Weight Gain in Grams Per Day
|
24.3 grams/day
Standard Deviation 14.6
|
23.6 grams/day
Standard Deviation 7.7
|
Adverse Events
Continuous Feeding Regimen
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Intermittent Bolus Feeding Regimen
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Continuous Feeding Regimen
n=12 participants at risk
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.
|
Intermittent Bolus Feeding Regimen
n=14 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
necrotizing enterocolitis
|
0.00%
0/12
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
aspiration
|
8.3%
1/12 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place