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

Malnutrition, Child Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05945459
• Other study ID #: LB.02.01/VII/214/KEP.036/2017
• Status: Completed
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: February 15, 2020

Study information

• Verified date: July 2023
• Source: National Cardiovascular Center Harapan Kita Hospital Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: February 15, 2020
• Est. primary completion date: November 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Days to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Congenital Heart Disease in Children
• Heart Defects, Congenital
• Heart Diseases
• Malnutrition
• Malnutrition, Child

Intervention

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).
• 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).

Locations

Country	Name	City	State
Indonesia	National Cardiovascular Center Harapan Kita	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
National Cardiovascular Center Harapan Kita Hospital Indonesia	Danone Institute International

Country where clinical trial is conducted

Indonesia, 

Outcome

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