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NCT04795076
Effect of Feeding With Nutrient Dense Formula in Malnourished Infants and Children With Congenital Heart Defects
NA trial testing Infant formula in Congenital Heart Disease in 65 participants. Completed in 9 February 2022.
9 February 2022
Quick facts
| Lead sponsor | Shahid Beheshti University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 65 |
| Start date | 3 April 2021 |
| Primary completion | 9 February 2022 |
| Estimated completion | 9 February 2022 |
| Sites | 1 location across Iran |
Drugs / interventions tested
- Infant formula — full drug profile →
Conditions studied
- Congenital Heart Disease — all drugs for Congenital Heart Disease →
Sponsor
Shahid Beheshti University
Who can join
Adults 6 Months to 24 Months, any sex, with Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Infants with congenital heart disease (CHD) are usually born with a normal weight but develop malnutrition over time, and about 20-50% of these children are usually malnourished. Malnutrition in these patients is multifactorial. To compensate for the increased need for infants and children with CHD, an increase in their caloric intake has been suggested. However, these patients may not be able to receive enough to meet the increased needs and catch-up growth. One of the suggested solutions in these patients to compensate for inadequate food intake is to increase the caloric density of milk or formula. For this purpose, the use of special formulas with higher calorie density or enrichment of normal formula or breast milk using special enrichment formula could be suggested. In the present study, the effect of increasing calorie intake by increasing the concentration of normal formula in comparison with formula with standard concentration on weight gain and other anthropometric indices of CHD patients with malnutrition will be compared.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The molecular mechanisms of cardiac development and related diseases.
Li Y, Du J, Deng S, Liu B, et al · · 2024 · cited 53× · PMID 39715759 · DOI 10.1038/s41392-024-02069-8
Verify or expand the search:
- PubMed search for NCT04795076
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Infant formula
Trials testing the same drug.
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- NCT03476889 — Safety and Tolerance of a Partly Fermented Infant Formula With Prebiotic Oligosaccharides in Healthy Infants · NA · unknown
- NCT03487094 — Growth and Tolerance of Infants Fed Formula for 16 Weeks · NA · completed
- NCT03320837 — Metabolomic Profile of Urine Samples From Neonates Fed With Breast Milk and an Infant Formula Enriched With Synbiotics · completed
- NCT03513991 — Evaluation of Different Protein Content of Formulas on Nutrition Status of Infants. · NA · completed
Other recruiting trials for Congenital Heart Disease
Currently open trials in the same condition.
- NCT07193719 — Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children · Phase 1, PHASE2 · recruiting
- NCT07023367 — Parent Navigator Program (PNP) to Improve Outcomes in Latino/x Children and Parents · NA · recruiting
- NCT06833320 — Propranolol Treatment for Postoperative Chylothorax · Phase 1, PHASE2 · recruiting
- NCT06668389 — Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary · Phase 4 · recruiting
- NCT06872320 — The Influence of Probiotics on Metabolome and Heart Rate Variability in Heart Failure of Structure Heart Disease · NA · active not recruiting
Other Shahid Beheshti University trials
Trials by the same sponsor.
- NCT06825377 — Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrom · NA · recruiting
- NCT06483932 — Barberry and Cardiometabolic Risk Factors in Individuals With Hypertriglyceridemia · NA · completed
- NCT06020950 — Chia Seeds Consumption in Hypertriglyceridemia · NA · completed
- NCT05995002 — Anthocyanin Intake on Cardiometabolic Biomarkers · NA · completed
- NCT05589350 — High-fat Yogurt and Plasma Lipids Profile · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04795076 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shahid Beheshti University
- Last refreshed: 10 February 2022
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