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

NCT ID: NCT05945459

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-14
• Study Completion Date: 2020-02-15

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. 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.

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.

Conditions

Congenital Heart Disease in Children; Malnutrition, Child

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention arm

High-calorie density formula (1 kcal/ml)

Group Type: EXPERIMENTAL

High-calorie density formula (1 kcal/ml)

Intervention Type: 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

Standard formula (0.67 kcal/ml)

Group Type: PLACEBO_COMPARATOR

Standard formula (0.67 kcal/ml)

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 14 Days
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danone Institute International

OTHER

Sponsor Role: collaborator

National Cardiovascular Center Harapan Kita Hospital Indonesia

OTHER

Sponsor Role: lead

Responsible Party

Eva M Marwali,MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reni Fitriasari, MD

Role: PRINCIPAL_INVESTIGATOR

National Cardiovascular Center Harapan Kita

Locations

National Cardiovascular Center Harapan Kita

Jakarta, , Indonesia

Countries

Indonesia

Other Identifiers

LB.02.01/VII/214/KEP.036/2017

Identifier Type: -

Identifier Source: org_study_id