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

Sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia (Other)

Overall Status

Completed

CT.gov ID

NCT05945459

Collaborator

Danone Institute International (Other)

158

Enrollment

Location

Arms

Actual Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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:

Is there any difference in nutritional status between both groups after 3 months?
Is there any difference in calorie intake per day between both groups during hospitalization?
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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease in Children Malnutrition, Child	Dietary Supplement: High-calorie density formula (1 kcal/ml) Dietary Supplement: Standard formula (0.67 kcal/ml)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

158 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 14, 2018

Actual Primary Completion Date :

Nov 3, 2019

Actual Study Completion Date :

Feb 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention arm High-calorie density formula (1 kcal/ml)	Dietary Supplement: High-calorie density formula (1 kcal/ml) 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).
Placebo Comparator: Control arm Standard formula (0.67 kcal/ml)	Dietary Supplement: Standard formula (0.67 kcal/ml) 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).

Arm

Intervention/Treatment

Experimental: Intervention arm

High-calorie density formula (1 kcal/ml)

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

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).

Placebo Comparator: Control arm

Standard formula (0.67 kcal/ml)

Dietary Supplement: Standard formula (0.67 kcal/ml)

Outcome Measures

Primary Outcome Measures

Nutritional status [After 3 months of intervention]
Numeric data of weight-for-length z-score (WLZ), length-for-age z-score (LAZ) and weight-for-age z-score (WAZ) based on the 2006 World Health Organization (WHO) Child Growth Standard

Secondary Outcome Measures

Calorie intake [From the date of randomization to the date of discharge, assessed up to 3 months]
Numeric data of the infants' total calorie intake (kcal/kg/day) during hospitalization
Weight [After 1, 2, and 3 months of intervention]
Numeric data of absolute weight (kg)
Length [After 1, 2, and 3 months of intervention]
Numeric data of absolute length (cm)
Weight-for-age z-score changes [From the date of randomization to after 1, 2, and 3 months of intervention]
Difference of weight-for-age z-score based on The 2006 WHO Child Growth Standard
Length-for-age z-score changes [From the date of randomization to after 1, 2, and 3 months of intervention]
Difference of length-for-age z-score based on The 2006 WHO Child Growth Standard
Weight-for-length z-score changes [From the date of randomization to after 1, 2, and 3 months of intervention]
Difference of weight-for-length z-score based on The 2006 WHO Child Growth Standard
Malnutrition risk [After 1, 2, and 3 months of intervention]
Risk ratios of malnutrition, defined as weight-for-length <-2 based on 2006 WHO Child Growth Standard
Mortality [Through study completion, an average of 3 months]
The event proportion of mortality (%)
Duration of mechanical ventilation [From the date of randomization to the date of hospital discharge, assessed up to 3 months]
The difference of mechanical ventilation duration (hours)
Length of stay [From the date of randomization to the date of discharge, assessed up to 3 months]
The difference of lengths of stay in intensive care unit and hospital (days)
Side effects [From the date of randomization to the date of hospital discharge, assessed up to 3 months]
The event proportion (%) of vomiting, diarrhea, gastrointestinal bleeding, constipation, and >50% residual gastric content

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Days to 1 Year

Sexes Eligible for Study:

All

Accepts 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