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

NCT ID: NCT05826769

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-21
• Study Completion Date: 2024-03-12

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.

Conditions

Congenital Heart Disease in Children; Post-cardiac Surgery; Malnutrition, Infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Energy- Protein Enriched Nutritional Formula

Liquid, ready-to-use Energy-Protein nutrition formula with energy density of 1 kCal/mL (EP formula)

Group Type: EXPERIMENTAL

Energy- Protein Enriched Nutritional Formula

Intervention Type: DIETARY_SUPPLEMENT

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.

Standard Nutritional Formula

Polymeric formula stage-1 and stage-2 for infants aged 0-6 months and 6-12 months accordingly, providing 0.67 kCal/mL (S-1/S-2 formula)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

High Calorie High Protein Nutritional Formula

Eligibility Criteria

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

• Minimum Eligible Age: 4 Weeks
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

KFSHRC

Jeddah, Outside North America, Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Abrar Shirbini

Role: CONTACT

ashirbini@kfshrc.edu.sa

00966126677777 ext. 42401

Ahmed Elmahrouk

Role: CONTACT

ael-mahrouk@kfshrc.edu.sa

00966126677777 ext. 40250

Facility Contacts

Sawsan Bassi

Role: primary

sbassi@kfshrc.edu.sa

+966505688897

Other Identifiers

2021-34

Identifier Type: -

Identifier Source: org_study_id