Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-06-08 @ 4:47 PM
Study NCT ID:
NCT05945459
Status:
COMPLETED
Last Update Posted:
2023-07-14
First Post:
2023-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of High-Calorie Formula on Nutritional and Clinical Outcomes Among Infants After Congenital Heart Surgery
Sponsor:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: