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

Sponsor

King Faisal Specialist Hospital & Research Centre, Jeddah (Other)

Overall Status

Recruiting

CT.gov ID

NCT05826769

Collaborator

(none)

Enrollment

Location

Arms

31.7

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease in Children Post-cardiac Surgery Malnutrition, Infant	Dietary Supplement: Energy- Protein Enriched Nutritional Formula	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 trialPatients 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

Masking:

None (Open Label)

Masking Description:

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.

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Jul 21, 2021

Actual Primary Completion Date :

Jul 27, 2022

Anticipated Study Completion Date :

Mar 12, 2024

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

after admission in ICU, will measure the Tolerability [5 days]
Gastric tolerance

Secondary Outcome Measures

Weight gain rate [90 days]
Weight velocity

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Weeks to 1 Year

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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