Intestinal Function in Neonates With Complex Congenital Heart Disease

Congenital Heart Defects Clinical Trial

Official title:

Intestinal Function in Neonates With Complex Congenital Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475357
• Other study ID #: HR 20394
• Status: Completed
• Phase: N/A
• First received: October 6, 2011
• Last updated: October 14, 2014
• Start date: October 2011
• Est. completion date: April 2014

Study information

• Verified date: October 2014
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 37 Weeks to 40 Weeks

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Heart Defects
• Failure to Thrive
• Growth Failure
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Enteral Feeds	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.	Duration (in days) until goal enteral feeds are achieved, an expected average of 3 weeks	No
Secondary	Intestinal Microflora Pattern	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.	30 days 1st post-partum month	No