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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

NCT05826769 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • King Faisal Specialist Hospital & Research Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Weeks
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-21
Primary Completion
2022-07-27
Completion
2024-03-12

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05826769 on ClinicalTrials.gov