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

Congenital Heart Disease in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05826769
• Other study ID #: 2021-34
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: March 12, 2024

Study information

• Verified date: April 2023
• Source: King Faisal Specialist Hospital & Research Centre, Jeddah
• Contact: Abrar Shirbini
• Phone: 00966126677777
• Email: ashirbini[@]kfshrc.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 12, 2024
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Weeks to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease in Children
• Heart Defects, Congenital
• Heart Diseases
• Infant Nutrition Disorders
• Malnutrition
• Malnutrition, Infant
• Post-cardiac Surgery

Intervention

Dietary Supplement:
• Energy- Protein Enriched Nutritional Formula
EN volume will start at 1 mL/kg/h and then increase by 1 mL/kg every 6 hours if tolerated, until reaching 130 mL/kg/d.

Locations

Country	Name	City	State
Saudi Arabia	KFSHRC	Jeddah	Outside North America

Sponsors (1)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Centre, Jeddah

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	after admission in ICU, will measure the Tolerability	Gastric tolerance	5 days
Secondary	Weight gain rate	Weight velocity	90 days