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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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Energy- Protein Enriched Nutritional Formula
Sponsored by
King Faisal Specialist Hospital & Research Centre, Jeddah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congenital Heart Disease in Children focused on measuring Energy Protein, Enriched, Enteral Nutrition, Cardiac Repair

Eligibility Criteria

4 Weeks - 1 Year (Child)All SexesDoes not accept 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

Sites / Locations

  • KFSHRCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Energy- Protein Enriched Nutritional Formula

Standard Nutritional Formula

Arm Description

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

Outcomes

Primary Outcome Measures

after admission in ICU, will measure the Tolerability
Gastric tolerance

Secondary Outcome Measures

Weight gain rate
Weight velocity

Full Information

First Posted
April 12, 2023
Last Updated
April 12, 2023
Sponsor
King Faisal Specialist Hospital & Research Centre, Jeddah
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1. Study Identification

Unique Protocol Identification Number
NCT05826769
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
July 27, 2022 (Actual)
Study Completion Date
March 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Faisal Specialist Hospital & Research Centre, Jeddah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease in Children, Post-cardiac Surgery, Malnutrition, Infant
Keywords
Energy Protein, Enriched, Enteral Nutrition, Cardiac Repair

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Energy- Protein Enriched Nutritional Formula
Arm Type
Experimental
Arm Description
Liquid, ready-to-use Energy-Protein nutrition formula with energy density of 1 kCal/mL (EP formula)
Arm Title
Standard Nutritional Formula
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Energy- Protein Enriched Nutritional Formula
Other Intervention Name(s)
High Calorie High Protein Nutritional Formula
Intervention Description
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.
Primary Outcome Measure Information:
Title
after admission in ICU, will measure the Tolerability
Description
Gastric tolerance
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Weight gain rate
Description
Weight velocity
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abrar Shirbini
Phone
00966126677777
Ext
42401
Email
ashirbini@kfshrc.edu.sa
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Elmahrouk
Phone
00966126677777
Ext
40250
Email
ael-mahrouk@kfshrc.edu.sa
Facility Information:
Facility Name
KFSHRC
City
Jeddah
State/Province
Outside North America
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sawsan Bassi
Phone
+966505688897
Email
sbassi@kfshrc.edu.sa

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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

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