Intestinal Function in Neonates With Complex Congenital Heart Disease
Condition: Congenital Heart Defects; Growth Failure
MeSH terms: Heart Diseases; Heart Defects, Congenital; Failure to Thrive
Study type: Interventional

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.
    

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.
    

Intervention name(s): Arm 1: NPO by mouth pre-operative; Arm 2: Fresh Breast Milk pre-operative
Intervention type(s): Other; Other
Intervention description(s): 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.; Infants randomized to Arm 2 of the study will receive their mother's own breast milk pre-operatively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: congenital heart defects; growth failure