Intestinal Function in Neonates With Complex Congenital Heart Disease

This study is currently recruiting participants.
Verified May 2013 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
Sinai Zyblewski, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01475357
First received: October 6, 2011
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Congenital Heart Defects
Growth Failure
Other: Arm 1: NPO by mouth pre-operative
Other: Arm 2: Fresh Breast Milk pre-operative

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intestinal Function in Neonates With Complex Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Change in urine lactulose/mannitol ratio over time [ Time Frame: post-natal day 3-4 (baseline), post-op days 7 and 14 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Enteral Feeds [ Time Frame: Duration (in days) until goal enteral feeds are achieved, an expected average of 3 weeks ] [ Designated as safety issue: No ]

    Specific Aim 2: To compare the duration (in days) until goal enteral feeds are successfully achieved in the trophic breastmilk fed group vs. NPO group.

    H1: Infants who receive trophic breastmilk feeds in the pre-operative period will successfully achieve goal enteral feeds in a shorter duration of time compared to those infants who were strictly NPO in the pre-operative period.


  • Intestinal Microflora Pattern [ Time Frame: 30 days 1st post-partum month ] [ Designated as safety issue: No ]

    Specific Aim 3: To qualitatively compare the intestinal microflora pattern over the first postpartum month as determined by stool microbiota of the trophic breastmilk fed group vs. NPO group.

    H1: The microbiota patterns of those infants who receive trophic breastmilk feeds in the pre-operative period will differ from those infants who were strictly NPO in the pre-operative period.



Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: NPO pre-operative
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
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.
Active Comparator: Arm 2: Fresh Breast Milk pre-operative
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
Infants randomized to Arm 2 of the study will receive their mother's own breast milk pre-operatively.

Detailed Description:

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 foundational hypothesis of this proposal is that term neonates (≥ 37 weeks gestation) with complex congenital heart disease (CHD) are vulnerable to disturbances in intestinal mucosal function, permeability, microflora, and local immune function, which ultimately result in feeding intolerance and poor somatic growth. By identifying biologic targets for perioperative intestinal protection, this project has the potential to shift and improve the paradigm of perioperative care for neonates with complex CHD. This pilot study will generate the data necessary to pursue K23 and R01 funding to further investigate postnatal intestinal maturation and function in neonates with complex CHD and cyanosis, specifically as it pertains to local immune function and inflammatory response.

The objectives of this proposal are to perform a single-center (MUSC), prospective, randomized pilot trial to investigate postnatal intestinal function in cardiac infants through the following Specific Aims:

Specific Aim 1: To compare the decrease in intestinal permeability as determined 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).

H1: Infants who receive trophic breastmilk feeds in the pre-operative period will demonstrate a more rapid decrease in intestinal permeability (improved postnatal intestinal maturation) over the first 2 weeks of life compared to those infants who were strictly NPO in the pre-operative period.

Specific Aim 2: To compare the duration (in days) until goal enteral feeds are successfully achieved in the trophic breastmilk fed group vs. NPO group.

H1: Infants who receive trophic breastmilk feeds in the pre-operative period will successfully achieve goal enteral feeds in a shorter duration of time compared to those infants who were strictly NPO in the pre-operative period.

Specific Aim 3: To qualitatively compare the intestinal microflora pattern over the first postpartum month as determined by stool microbiota of the trophic breastmilk fed group vs. NPO group.

H1: The microbiota patterns of those infants who receive trophic breastmilk feeds in the pre-operative period will differ from those infants who were strictly NPO in the pre-operative period.

  Eligibility

Ages Eligible for Study:   37 Weeks to 40 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475357

Contacts
Contact: Sinai C Zyblewski, MD 843-792-1035 chois@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Sinai Zyblewski, MD    843-792-1035    chois@musc.edu   
Principal Investigator: Sinai Zyblewski, MD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Sinai C Zyblewski, MD Medical University of South Carolina
  More Information

Publications:

Responsible Party: Sinai Zyblewski, Assistant Professor, Pediatric Cardiology, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01475357     History of Changes
Other Study ID Numbers: HR 20394
Study First Received: October 6, 2011
Last Updated: May 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
congenital heart defects
growth failure

Additional relevant MeSH terms:
Failure to Thrive
Heart Defects, Congenital
Heart Diseases
Growth Disorders
Pathologic Processes
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 22, 2014