High frequency oscillation versus conventional mechanical ventilation in newborns with congenital diaphragmatic hernia: an international randomized controlled trial

Completed

• Conditions: CDH; congenital diaphragmatic hernia; 10038686; 10028971

• Registration Number: NL-OMON36937
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

•Antenatal diagnosis of congenital diaphragmatic hernia
•Prenatal informed consent
•The children are born in one of the participating centres
•The children are born at or after a gestational age of 34 weeks
•Infants who received a foetal intervention may be included

Exclusion Criteria

•Infants with a severe chromosomal anomaly, like trisomy 18 or trisomy 13, which may imply a decision to stop further life-saving medical treatment
•Infants born with a severe cardiac anomaly, expected to need corrective surgery in the first 60 days of life (such as transposition of the great arteries or double outlet right ventricle)
•Infants born with renal anomalies associated with oligohydramnios
•Infants born with severe orthopaedic and skeletal deformities which are likely to influence thoracic and / or lung development (such as chest wall deformities and spine anomalies)
•Infants born with severe anomalies of the central nervous system

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Oxygen dependency at day 28 and/or death within the first 28 days of life. </p><br>