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

July 11, 2023 updated by: Eva M Marwali,MD, National Cardiovascular Center Harapan Kita Hospital Indonesia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 11420
        • National Cardiovascular Center Harapan Kita

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status
Time Frame: 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
After 3 months of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calorie intake
Time Frame: 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
From the date of randomization to the date of discharge, assessed up to 3 months
Weight
Time Frame: After 1, 2, and 3 months of intervention
Numeric data of absolute weight (kg)
After 1, 2, and 3 months of intervention
Length
Time Frame: After 1, 2, and 3 months of intervention
Numeric data of absolute length (cm)
After 1, 2, and 3 months of intervention
Weight-for-age z-score changes
Time Frame: 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
From the date of randomization to after 1, 2, and 3 months of intervention
Length-for-age z-score changes
Time Frame: 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
From the date of randomization to after 1, 2, and 3 months of intervention
Weight-for-length z-score changes
Time Frame: 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
From the date of randomization to after 1, 2, and 3 months of intervention
Malnutrition risk
Time Frame: 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
After 1, 2, and 3 months of intervention
Mortality
Time Frame: Through study completion, an average of 3 months
The event proportion of mortality (%)
Through study completion, an average of 3 months
Duration of mechanical ventilation
Time Frame: From the date of randomization to the date of hospital discharge, assessed up to 3 months
The difference of mechanical ventilation duration (hours)
From the date of randomization to the date of hospital discharge, assessed up to 3 months
Length of stay
Time Frame: 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)
From the date of randomization to the date of discharge, assessed up to 3 months
Side effects
Time Frame: 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
From the date of randomization to the date of hospital discharge, assessed up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Collaborators

Danone Institute International

Investigators

  • Principal Investigator: Reni Fitriasari, MD, National Cardiovascular Center Harapan Kita

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2018

Primary Completion (Actual)

November 3, 2019

Study Completion (Actual)

February 15, 2020

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB.02.01/VII/214/KEP.036/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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