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

NCT05945459 | Completed

• 1 other identifier: LB.02.01/VII/214/KEP.036/2017
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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

Conditions

Congenital Heart Disease in Children; Malnutrition, Child

Keywords

anthropometry; congenital heart disease; infant formula; nutritional status; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Calorie intake

  From the date of randomization to the date of discharge, assessed up to 3 months

• Weight

  After 1, 2, and 3 months of intervention

• Length

  After 1, 2, and 3 months of intervention

• Weight-for-age z-score changes

  From the date of randomization to after 1, 2, and 3 months of intervention

• Length-for-age z-score changes

  From the date of randomization to after 1, 2, and 3 months of intervention

Study Arms (2)

Intervention arm

EXPERIMENTAL

High-calorie density formula (1 kcal/ml)

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

Control arm

PLACEBO COMPARATOR

Standard formula (0.67 kcal/ml)

Dietary Supplement: Standard formula (0.67 kcal/ml)

Interventions

High-calorie density formula (1 kcal/ml) DIETARY_SUPPLEMENT

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).

Intervention arm

Standard formula (0.67 kcal/ml) DIETARY_SUPPLEMENT

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).

Control arm

Eligibility Criteria

• Age: 14 Days - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cardiovascular Center Harapan Kita Hospital Indonesia: lead
• Danone Institute International: collaborator

Study Sites (1)

National Cardiovascular Center Harapan Kita

Jakarta, 11420, Indonesia

Location

MeSH Terms

Conditions

Child Nutrition Disorders; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Reni Fitriasari, MD

  National Cardiovascular Center Harapan Kita

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 14, 2023
• Study Start: February 14, 2018
• Primary Completion: November 3, 2019
• Study Completion: February 15, 2020
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)