CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
Arm 1: NPO by mouth pre-operative +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/NCT01475357
NCT01475357N/ACompleted

Intestinal Function in Neonates With Complex Congenital Heart Disease

Medical University of South Carolina·interventional·Posted Nov 21, 2011·Updated Oct 15, 2014

In Brief

A clinical study evaluating Arm 1: NPO by mouth pre-operative and Arm 2: Fresh Breast Milk pre-operative for Congenital Heart Defects and Growth Failure. Completed, enrolled 27 participants across 1 site.

Detailed Summary

Postnatal intestinal function in cardiac infants. The overall goal of this proposal is to address a widespread health problem in the pediatric cardiac infant population - poor postnatal growth - through a collaborative effort between pediatric cardiology, cardiothoracic surgery, neonatology, microbiology, and immunology. The hypothesis is that term neonates with complex congenital heart disease (CHD) who receive trophic breastmilk feeds in the pre-operative period will show improved gut function than neonates who were strictly NPO (nothing by mouth) in the pre-operative period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 21, 2011
Enrollment StartOct 1, 2011
Primary CompletionMar 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.6 years ago

Interventions

Arm 1: NPO by mouth pre-operativeother

Current treatment for infants born with cardiac defects awaiting surgery is to keep them NPO pre-operatively. Arm 1 will make no changes to this current policy.

Arm 2: Fresh Breast Milk pre-operativeother

Infants randomized to Arm 2 of the study will receive their mother's own breast milk pre-operatively.