An interventional study of Energy- Protein Enriched Nutritional Formula in Congenital Heart Disease in Children, Post-cardiac Surgery and Malnutrition, Infant, sponsored by King Faisal Specialist Hospital & Research Centre, Jeddah. Status unknown at 1 site in Saudi Arabia. Open to participants aged 4 Weeks to 1 Year. Per ClinicalTrials.gov, last updated 2023-04-24.
Sponsored by King Faisal Specialist Hospital & Research Centre, Jeddah · Not applicable, Interventional, and Supportive care
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
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.
67 studies on the registry are indexed under Infant Nutrition Disorders; 14 are open to participants now.
This study's planned enrollment of 60 is below the median of 180 across 46 interventional studies indexed under Infant Nutrition Disorders.
Browse Infant Nutrition Disorders studies →King Faisal Specialist Hospital & Research Centre, Jeddah is the lead sponsor of 5 studies on the registry; none are open to participants now.
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The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Liquid, ready-to-use Energy-Protein nutrition formula with energy density of 1 kCal/mL (EP formula)
Dietary Supplement: Energy- Protein Enriched 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)
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
after admission in ICU, will measure the Tolerability
Gastric tolerance
Time frame: 5 days
Weight gain rate
Weight velocity
Time frame: 90 days
Plan to share: Undecided
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King Faisal Specialist Hospital & Research Centre, Jeddah