Clinical trial NCT05945459: The Effect of High-Calorie Formula on Nutritional and Clinical Outcomes Among Infants After Congenital Heart Surgery
Official title: The Effect of High-calorie Density Formula Versus Standard Formula in Calorie Intake, Nutritional Status, and Clinical Outcomes Among Infants Who Underwent Congenital Heart Disease Surgery: A Randomized, Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease in Children
Malnutrition, Child
Keywords: anthropometry
congenital heart disease
infant formula
nutritional status
randomized controlled trial
Lead sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
Sponsor class: OTHER
Collaborators: name: Danone Institute International
First posted: 2023-07-14
Enrollment: 158
Sex: ALL
Minimum age (years): 14
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Nutritional status
timeFrame: After 3 months of intervention
Secondary outcomes:
measure: Calorie intake
timeFrame: From the date of randomization to the date of discharge, assessed up to 3 months
measure: Weight
timeFrame: After 1, 2, and 3 months of intervention
measure: Length
timeFrame: After 1, 2, and 3 months of intervention
measure: Weight-for-age z-score changes
timeFrame: From the date of randomization to after 1, 2, and 3 months of intervention
measure: Length-for-age z-score changes
timeFrame: From the date of randomization to after 1, 2, and 3 months of intervention
measure: Weight-for-length z-score changes
timeFrame: From the date of randomization to after 1, 2, and 3 months of intervention
measure: Malnutrition risk
timeFrame: After 1, 2, and 3 months of intervention
measure: Mortality
timeFrame: Through study completion, an average of 3 months
measure: Duration of mechanical ventilation
timeFrame: From the date of randomization to the date of hospital discharge, assessed up to 3 months
measure: Length of stay
timeFrame: From the date of randomization to the date of discharge, assessed up to 3 months
measure: Side effects
timeFrame: From the date of randomization to the date of hospital discharge, assessed up to 3 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita
Study officials:
affiliation: National Cardiovascular Center Harapan Kita
name: Reni Fitriasari, MD
role: PRINCIPAL_INVESTIGATOR
References: