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

NCT05945459 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2023-07-14

No results posted yet for this study

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.

Conditions

  • Congenital Heart Disease in Children
  • Malnutrition, Child

Interventions

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).

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).

Sponsors & Collaborators

  • Danone Institute International

    collaborator OTHER

  • National Cardiovascular Center Harapan Kita Hospital Indonesia

    lead OTHER

Principal Investigators

  • Reni Fitriasari, MD · National Cardiovascular Center Harapan Kita

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Days
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-14
Primary Completion
2019-11-03
Completion
2020-02-15

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05945459 on ClinicalTrials.gov