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Intestinal Function in Neonates With Complex Congenital Heart Disease

NCT01475357 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2014-10-15

No results posted yet for this study

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.

Conditions

  • Congenital Heart Defects
  • Growth Failure

Interventions

OTHER

Arm 1: NPO by mouth pre-operative

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.

OTHER

Arm 2: Fresh Breast Milk pre-operative

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

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Sinai C Zyblewski, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
37 Weeks
Max Age
40 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-03-31
Completion
2014-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01475357 on ClinicalTrials.gov