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 (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

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease in Children; Post-cardiac Surgery; Malnutrition, Infant
• Intervention / Treatment: Dietary supplement: Energy- Protein Enriched Nutritional Formula

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abrar Shirbini; Phone Number: 42401 00966126677777; Email: ashirbini@kfshrc.edu.sa
• Study Contact Backup: Name: Ahmed Elmahrouk; Phone Number: 40250 00966126677777; Email: ael-mahrouk@kfshrc.edu.sa

Study Locations

• Saudi Arabia
  • Outside North America
    • Jeddah, Outside North America, Saudi Arabia
      • Recruiting
      • KFSHRC
      • Contact: Sawsan Bassi; Phone Number: +966505688897; Email: sbassi@kfshrc.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Energy- Protein Enriched Nutritional Formula; Liquid, ready-to-use Energy-Protein nutrition formula with energy density of 1 kCal/mL (EP formula)	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.; Other Names: High Calorie High Protein Nutritional Formula
No Intervention: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
after admission in ICU, will measure the Tolerability	Gastric tolerance	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight gain rate	Weight velocity	90 days

Collaborators and Investigators

• Sponsor: King Faisal Specialist Hospital & Research Centre, Jeddah

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Actual): July 27, 2022
• Study Completion (Anticipated): March 12, 2024

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Enteral Nutrition; Energy Protein, Enriched; Cardiac Repair
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Nutrition Disorders; Cardiovascular Abnormalities; Heart Diseases; Malnutrition; Heart Defects, Congenital; Infant Nutrition Disorders
• Other Study ID Numbers: 2021-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No