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NCT Number: NCT05945459

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

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.

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Key information

Conditions

Congenital Heart Disease in Children Cardiovascular Abnormalities Cardiovascular Diseases Child Nutrition Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Malnutrition, Child Nutrition Disorders Nutritional and Metabolic Diseases

Age range

14 day–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cardiovascular Center Harapan Kita

Jakarta, 11420, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Weight

    Time frame: After 1, 2, and 3 months of intervention

    Numeric data of absolute weight (kg)

  3. Length

    Time frame: After 1, 2, and 3 months of intervention

    Numeric data of absolute length (cm)

  4. 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

  5. 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

  6. 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

  7. 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

  8. Mortality

    Time frame: Through study completion, an average of 3 months

    The event proportion of mortality (%)

  9. 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)

  10. 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)

  11. 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

Sponsors and collaborators

Lead sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Other

Collaborators

  • Danone Institute International

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 14, 2023
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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