Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT02274220
Brief 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.
Study:
NCT02274220
Study Brief:
Protocol Section:
NCT02274220