Investigating the effect of adequate energy and protein intake for children after cardiopulmonary bypass surgery

Not Applicable

• Conditions: Congenital heart disease; Neonatal Diseases; Congenital malformations of the circulatory system

• Registration Number: ISRCTN10130540
• Lead Sponsor: Guangzhou Women and Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-10
• Last Update Posted: 28 September 2020
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

1. Diagnosis of congenital heart disease and planned cardiopulmonary bypass
2. Aged between 1 month and 1 year
3. Informed consent given by parent(s) or legal guardian
4. Gestational age at birth >36 weeks.

Exclusion Criteria

1. Any major congenital abnormality such as congenital diaphragmatic hernia or tracheoesophageal fistula
2. Acquired extra-cardiac disorder that could independently affect the primary endpoint such as meconium aspiration with a need for high-frequency ventilation, persistent renal failure requiring dialysis, chylothorax and gastrointestinal necrosis, or postoperative use of steroids in ICU

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. New infections acquired during the Cardiac Intensive Care Unit (CICU) stay and the duration of antibiotic treatment assessed using patient notes at the time of CICU discharge<br> 2. The duration of CICU dependency assessed using patient notes at the time of CICU discharge<br>