To Assess the Efficacy of Early Administration of Energy Enriched and Protein Enriched Formula in Post Cardiac Repair Infants: a Randomized Controlled Trial, Comparative Study

Not Applicable

Recruiting

• Conditions: Malnutrition, Infant; Congenital Heart Disease in Children; Post-cardiac Surgery
• Interventions: Dietary Supplement: Energy- Protein Enriched Nutritional Formula

• Registration Number: NCT05826769
• Lead Sponsor: King Faisal Specialist Hospital & Research Centre, Jeddah

Brief Summary

Congenital heart disease (CHD) is a public health problem, A substantial percentage of infants and toddlers with CHD undergo cardiopulmonary bypass surgery. Undernutrition affects up to 90% of these patients, and it's contributed to worse surgical and neurological outcomes. Infants with CHD are typically delivered at full term with a normal birth weight. However, as time passes, their development may become stunted. There are no negotiated guidelines for nutritional monitoring and intervention in this age bracket of infants. Through the use of Energy Enriched and Protein Enriched nutrition formula during the postoperative phase, this has shown to be well tolerated and support in delivering higher nutrition intakes within the first days after surgery. The objective of this research is to assess the long term outcome of patients who have had energy- and protein-rich nutrition formulas post cardiac surgery. An open, 2-arm, randomized controlled trials will be conducted to assess the efficacy of early administration of energy enriched and protein enriched formula in post cardiac repair infants. The expected primary outcome is that intervention group will have good tolerance to feeding and the secondary outcome is the significant weight gain rate (weight velocity) in comparing to control groups

Detailed Description

Due to a high incidence of 9/1000 live births, congenital heart disease (CHD) is a public health problem, A substantial percentage of infants and toddlers with CHD undergo cardiopulmonary bypass surgery. Undernutrition affects up to 90% of these patients, and it's contributed to worse surgical and neurological outcomes. Infants with CHD are typically delivered at full term with a normal birth weight. However, as time passes, their development may become stunted. There are no negotiated guidelines for nutritional monitoring and intervention in this age bracket of infants. Through the use of Energy Enriched and Protein Enriched nutrition formula during the postoperative phase, this has shown to be well tolerated and support in delivering higher nutrition intakes within the first days after surgery. Numerous clinical trials have been conducted (Zhang H et al., 2018; Scheeffer. et al., 2019) and were designed to explore the effects of early introduction of Energy Enriched and Protein Enriched formula (EP) to infants with CHD. The research found that feeding EP is correlated with improved weight gain and nutritional status, and also a decrease in Hospital Length Of Stay (HLOS) as well as antibiotic use, but this also causes increased feeding discomfort. The signs of feeding discomfort, on the other hand, were improved by medication and had little effect on feeding progress.

The objective of this research is to assess the long term outcome of patients who have had energy- and protein-rich nutrition formulas post cardiac surgery.

Study Timeline

• Study Start: 2021-07-21
• Primary Completion: 2022-07-27
• Status Verified: 2023-04
• Study First Submitted: 2023-04-12
• Study First Submitted QC: 2023-04-12
• Last Update Submitted: 2023-04-12
• Study First Posted: 2023-04-24
• Last Update Posted: 2023-04-24
• Study Completion: 2024-03-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. infants born at term, age between 4 weeks and 12 months
2. post congenital heart surgery (RACHS score 2)

Exclusion Criteria

1. syndromic patients
2. if patient is on parenteral nutrition (PN)
3. premature
4. combined inherited metabolic or chromosomal diseases
5. liver and kidney dysfunction before enrollment (index >2 times the upper limit of normal)
6. upper GI activity, vomiting, diarrhea, bloating, and other symptoms before enrollment
7. breastfeeding patients.
8. cow's milk allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Energy- Protein Enriched Nutritional Formula	Energy- Protein Enriched Nutritional Formula	Liquid, ready-to-use Energy-Protein nutrition formula with energy density of 1 kCal/mL (EP formula)

Primary Outcome Measures

Name	Time	Method
after admission in ICU, will measure the Tolerability	5 days	Gastric tolerance

Secondary Outcome Measures

Name	Time	Method
Weight gain rate	90 days	Weight velocity

Trial Locations

Locations (1)

KFSHRC; 🇸🇦 Jeddah, Outside North America, Saudi Arabia