CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Continuous Feeding Regimen +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02657629
NCT02657629N/ACompleted
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Comparison of Feeding Strategies After Stage 1 Procedures for Hypoplastic Left Heart Syndrome Infants: A Randomized Controlled Trial

Columbia University·interventional·Posted Jan 18, 2016·Updated Feb 15, 2016

In Brief

A clinical study evaluating Continuous Feeding Regimen and Intermittent Bolus Feeding Regimen for Hypoplastic Left Heart Syndrome and Growth Failure. Completed, enrolled 28 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoplastic Left Heart Syndrome, Growth Failure
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 18, 2016
Enrollment StartDec 1, 2009
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.5 years ago

Interventions

Continuous Feeding Regimenother

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 Regimenother

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.