The Effect of High-Calorie Formula on Nutritional and Clinical Outcomes Among Infants After Congenital Heart Surgery

National Cardiovascular Center Harapan Kita Hospital Indonesia

Status: Completed

Conditions: Malnutrition, Child; Congenital Heart Disease in Children

Treatments: Dietary Supplement: High-calorie density formula (1 kcal/ml); Dietary Supplement: Standard formula (0.67 kcal/ml)

Study type: Interventional

Funder types: Other

Identifiers

NCT05945459

LB.02.01/VII/214/KEP.036/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: All

Ages: 14 days to 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient of less than 1 year of age who underwent congenital heart surgery procedure in Harapan Kita National Cardiovascular Center
• Risk adjustment for congenital heart surgery (RACHS) score 2-4
• Patients who do not get exclusive breastfeeding due to any cause

Exclusion criteria

• History of prematurity (<37 weeks gestational age)
• Formula intolerance or cow milk protein allergy
• Lethal chromosome abnormality
• Galactosemia
• Gastrointestinal malformation or obstruction
• Renal failure
• Liver disease
• Metabolic abnormalities
• Need for extracorporeal membrane oxygenation

Drop-out

• Patients who develop diarrhea for more than 5 days during the study period despite getting adequate therapy
• Patients who need prolonged total parenteral nutrition (e.g., gastrointestinal bleeding due to any cause, chylothorax, etc.)
• Patients with necrotizing enterocolitis during the study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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158 participants in 2 patient groups, including a placebo group

Intervention arm

Experimental group

Description:

High-calorie density formula (1 kcal/ml)

Treatment:

Dietary Supplement: High-calorie density formula (1 kcal/ml)

Control arm

Placebo Comparator group

Description:

Standard formula (0.67 kcal/ml)

Treatment:

Dietary Supplement: Standard formula (0.67 kcal/ml)