Congenital Heart Disease in Children Clinical Trial
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
NCT number | NCT05826769 |
Other study ID # | 2021-34 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 21, 2021 |
Est. completion date | March 12, 2024 |
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
Status | Recruiting |
Enrollment | 60 |
Est. completion date | March 12, 2024 |
Est. primary completion date | July 27, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Weeks to 1 Year |
Eligibility | Inclusion Criteria: 1. infants born at term, age between 4 weeks and 12 months 2. post congenital heart surgery (RACHS score 2) Exclusion Criteria: 1. syndromic patients 2. if patient is on parenteral nutrition (PN) 3. premature 4. combined inherited metabolic or chromosomal diseases 5. liver and kidney dysfunction before enrollment (index >2 times the upper limit of normal) 6. upper GI activity, vomiting, diarrhea, bloating, and other symptoms before enrollment 7. breastfeeding patients. 8. cow's milk allergy |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | KFSHRC | Jeddah | Outside North America |
Lead Sponsor | Collaborator |
---|---|
King Faisal Specialist Hospital & Research Centre, Jeddah |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | after admission in ICU, will measure the Tolerability | Gastric tolerance | 5 days | |
Secondary | Weight gain rate | Weight velocity | 90 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05975658 -
WIReD: Wireless Interstage Remote Device Study
|
||
Completed |
NCT05546983 -
How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?
|
||
Completed |
NCT03229538 -
STeroids to REduce Systemic Inflammation After Infant Heart Surgery
|
Phase 3 | |
Completed |
NCT05579964 -
The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot
|
Phase 2/Phase 3 | |
Recruiting |
NCT04604418 -
Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
|
||
Recruiting |
NCT05128084 -
Amotosalen and Platelet Transfusion in Pediatric Heart Surgery
|
||
Completed |
NCT05778240 -
Adherence to Palivizumab Prophylaxis
|
N/A | |
Completed |
NCT04666857 -
Family Centred Early Intervention of Infants With Congenital Heart Disease
|
N/A | |
Terminated |
NCT03136900 -
Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of With Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation,After Surgery for Congenital Heart Disease, in Infants.
|
N/A | |
Recruiting |
NCT05910320 -
Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
|
N/A | |
Not yet recruiting |
NCT05778175 -
Common Cases in Pediatric Intensive Care in Assuit University Cardiology Institute, a Clinical Audit
|
||
Completed |
NCT05284500 -
Predictive Pre and Peroperative Factors for MODS-2 in Pediatric Cardiac Surgery
|
||
Completed |
NCT04295239 -
Non-invasive Monitoring of Cerebral Self-regulation in Perioperative Neonatal Cardiac Surgery
|
N/A | |
Completed |
NCT05142046 -
Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery
|
||
Recruiting |
NCT04040452 -
Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery
|
Phase 4 | |
Not yet recruiting |
NCT06431269 -
Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
|
N/A | |
Recruiting |
NCT05268094 -
Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)
|
N/A | |
Recruiting |
NCT04315610 -
Personalized Mobile App for Parents of Infants With Cardiac Disease
|
N/A | |
Completed |
NCT04018079 -
Left Ventricular Dysfunction Post-surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis
|
||
Recruiting |
NCT05496803 -
Impact of Systematic Nursing Guidance on the Psychological Effects of Parents of Children With Cardiac Catheterization.
|
N/A |