Intestinal Function in Neonates With Complex Congenital Heart Disease

NCT01475357 | Completed DMC

• 1 other identifier: HR 20394
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

congenital heart defects; growth failure

Outcome Measures

Primary Outcomes (1)

• Change in urine lactulose/mannitol ratio over time

  Specific Aim 1: compare decrease in intestinal permeability by urine lactulose: mannitol ratios of the trophic breastmilk fed group (intervention) vs. NPO (nothing by mouth) group (current care) amongst neonates with complex CHD over 3 different time points (postnatal day 3-4, post-operative day 7-8, and post-operative day 13-14).

  post-natal day 3-4 (baseline), post-op days 7 and 14

Secondary Outcomes (2)

• Enteral Feeds

  Duration (in days) until goal enteral feeds are achieved, an expected average of 3 weeks

• Intestinal Microflora Pattern

  30 days 1st post-partum month

Study Arms (2)

Arm 1: NPO pre-operative

OTHER

1\) Current care - NPO (nothing by mouth) postnatal intestinal function of neonates with complex CHD who receive enteral trophic breastmilk (10cc/kg/day) feeds (intervention) vs NPO (nothing by mouth) in the pre-operative period.

Other: Arm 1: NPO by mouth pre-operative

Arm 2: Fresh Breast Milk pre-operative

ACTIVE COMPARATOR

2\) Intervention - Trophic mother's own fresh (non-frozen) breastmilk gavage feeds via nasogastric tube every 3 hours at 10 cc/kg/day

Other: Arm 2: Fresh Breast Milk pre-operative

Interventions

Arm 1: NPO by mouth pre-operative OTHER

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 1: NPO pre-operative

Arm 2: Fresh Breast Milk pre-operative OTHER

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

Arm 2: Fresh Breast Milk pre-operative

Eligibility Criteria

• Age: 37 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Study subjects will be male and female neonates admitted to MUSC PCICU or NICU prior to 72 hours of life who are gestational age ≥ 37 weeks.
• inpatient status at MUSC for a minimum of 48 hours prior to planned surgery and have a postnatal diagnosis of complex congenital heart disease - defined as a structural heart defect requiring cardiac surgery (reparative or palliative) prior to hospital discharge.

You may not qualify if:

• Infants with hemodynamic instability in the pre-operative period requiring mechanical circulatory support or
• who have the presence of lactate \> 3 after the first 24 hours of admission
• admission from home
• major congenital extracardiac abnormalities (i.e. renal, brain, GI)
• cardiac surgery will not be performed at MUSC, and
• mother does not plan to pump breastmilk during the infant's first week of life.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (41)

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MeSH Terms

Conditions

Heart Defects, Congenital; Failure to Thrive

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sinai C Zyblewski, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pediatric Cardiology

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: November 21, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

US (1)