The Effect of High-Calorie Formula on Nutritional and Clinical Outcomes Among Infants After Congenital Heart Surgery
Condition: Congenital Heart Disease in Children; Malnutrition, Child
MeSH terms: Heart Diseases; Heart Defects, Congenital; Malnutrition; Child Nutrition Disorders
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare the effect of high-calorie density formula
      (HDF) and standard formula (SF) in infants with congenital heart surgery. The main questions
      it aims to answer are:

        1. Is there any difference in nutritional status between both groups after 3 months?

        2. Is there any difference in calorie intake per day between both groups during
           hospitalization?

        3. Is there any difference in clinical outcomes (mortality, duration of using mechanical
           ventilation, length of stay, and events of side effects) between both groups?

      A group of participants will be given HDF (1 kcal/ml) from enrollment until three months.
      Researchers will compare them to the group of participants who are given SF (0.67 kcal/ml) to
      see if there is any difference in nutritional status, calorie intake, and other clinical
      outcomes between the two groups.
    

Detailed description: 
      The study is a randomized, double-blind controlled trial to compare the efficacy of HDF
      formula compared to SF in nutritional and clinical outcomes among infants who had congenital
      heart surgery in Harapan Kita National Cardiovascular Centre (HKNCC), Jakarta, Indonesia.

      The researchers use consecutive sampling to include eligible infants and obtain informed
      consent from the parent or legal guardian of infants who fulfilled the eligibility criteria.
      Block randomization is done by a research assistant, and then the allocation is prepared
      using a sealed envelope to assign infants into HDF and SF groups.

      Participants are then assessed by a multi-professional team and given enteral feeds based on
      local guidelines. Routine follow-up is done at 2 weeks, 1 month, 2 months, and 3 months after
      the intervention to record weight, length, and any episode of complication or adverse events.
    

Intervention name(s): High-calorie density formula (1 kcal/ml); Standard formula (0.67 kcal/ml)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The dose is started from 20ml/kg/day divided into 8 feeds and increased by 20ml/kg/day until the feeding goal is reached (120-150ml/kg/day) during hospitalization. The intervention is then continued after discharge for 3 months (ad libitum).; The dose is started from 20ml/kg/day divided into 8 feeds and increased by 20ml/kg/day until the feeding goal is reached (120-150ml/kg/day) during hospitalization. The intervention is then continued after discharge for 3 months (ad libitum).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anthropometry; congenital heart disease; infant formula; nutritional status; randomized controlled trial