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

NCT05826769 | Unknown DMC

• 1 other identifier: 2021-34
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Energy Protein, Enriched; Enteral Nutrition; Cardiac Repair

Outcome Measures

Primary Outcomes (1)

• after admission in ICU, will measure the Tolerability

  Gastric tolerance

  5 days

Secondary Outcomes (1)

• Weight gain rate

  90 days

Study Arms (2)

Energy- Protein Enriched Nutritional Formula

EXPERIMENTAL

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

Dietary Supplement: Energy- Protein Enriched Nutritional Formula

Standard Nutritional Formula

NO INTERVENTION

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)

Interventions

Energy- Protein Enriched Nutritional Formula 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.

Also known as: High Calorie High Protein Nutritional Formula

Energy- Protein Enriched Nutritional Formula

Eligibility Criteria

• Age: 4 Weeks - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

KFSHRC

Jeddah, Outside North America, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Infant Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Abrar Shirbini

CONTACT

00966126677777; ashirbini@kfshrc.edu.sa

Ahmed Elmahrouk

CONTACT

00966126677777; ael-mahrouk@kfshrc.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: According to national regulations, distribution of infant formula inside the hospital without a proper label is not allowed; therefore, subjects can not be blinded in this study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Patients are randomized before surgery in blocks of 2 using a computer-generated randomization list into intervention and control groups * This will be An open, 2-arm,randomized controlled trial

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 24, 2023
• Study Start: July 21, 2021
• Primary Completion: July 27, 2022
• Study Completion: March 12, 2024
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

SA (1)