Feeding Study - Effects Post-cardiac Surgery
Condition: Heart Disease; Dietary Modification; Insulin Resistance
MeSH terms: Heart Diseases; Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this randomized trial is to clarify the role of enteral nutrition (EN) on the
      relationship between cardiopulmonary bypass-induced inflammation and insulin resistance by
      investigating the effects of two different feeding strategies in infants following cardiac
      surgery. The study's primary objective is to determine if early and higher volume feeding
      modifies the relationship between the severity of postoperative systemic inflammation and
      insulin resistance.
    

Detailed description: 
      Good nutrition is important for patients after surgery. Patients who are given food tend to
      have fewer infections, better wound healing, and are possibly discharged more quickly from
      the intensive care unit and hospital. However, the best time to start feeds and the speed at
      which they can be increased is unclear. This may be particularly true for young children who
      have undergone heart surgery using a heart-lung bypass machine (bypass surgery). Bypass
      surgery can cause inflammation that can change the way the body uses energy and nutrients.
      Specifically, after bypass the body can become insensitive to insulin (insulin resistant),
      which means that the cells in the body don't take up sugar from the blood like they are
      supposed to, and this may lead to complications from the surgery. In a recent study we found
      that inflammation and insulin resistance was not associated with as many complications in
      children who were being fed. We are not sure if feeding changed the way in which the body
      responded after surgery or if doctors chose to feed only patients who were already recovering
      well. In general, doctors often hesitate to feed patients immediately after surgery because
      they worry that the body may not be ready for food although there is not much information to
      prove that this worry is correct. Starting feeds early using a structured feeding plan may be
      good during the recovery from heart surgery, even in our most vulnerable patients. We
      therefore designed this study to see if starting feeds early after bypass surgery and
      increasing them more quickly than our usual routine would decrease inflammation and insulin
      resistance. We will only study children younger than 6 months of age because they are at
      higher risk of complications from bypass surgery.
    

Intervention name(s): Rapid advancement of feeds; Standard advancement of feeds
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Feeding is initiated on first postoperative day. Bolus feeds are started at 1 mL/kg every three hours and up-titrated by 1 mL/kg every feed (Q 3 hours) to a goal of 10 mL/kg/feed (equivalent to approximately 50 kcal/kg/day). Feeding volume will exceed 20 mL/kg/day by 6 hours following protocol initiation and reach target feeds by 27 hours of protocol initiation.; Feeding is initiated on first postoperative day. Bolus feeds are started at 3 mL every three hours for 24 hours. Bolus feeds then up-titrated by 1 mL/kg every-other feed (Q 6 hours) for 24 hours. Bolus feeds then up-titrated by 1mL/kg every feed for to a goal of 10 mL/kg/feed (equivalent to approximately 50 kcal/kg/day). Feeding volume will reach target feeds by 60-63 hours after protocol initiation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: systemic inflammation; glucose metabolism; glucose-insulin ratio