Physiological-based cord clamping for infants with congenital diaphragmatic hernia: a multicentre randomised controlled trial

Recruiting

• Conditions: Congenital diaphragmatic hernia; 10010613; stabilisation; 10027664; 10028920

• Registration Number: NL-OMON54953
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

- Fetus/infant diagnosed with left sided CDH
- Isolated CDH: no associated structural or genetic abnormalities that are
diagnosed before birth
- Gestational age at delivery >35wks

Exclusion Criteria

- Right sided or bilateral CDH
- Major associated anomalies (structural and/or genetic)
- Maternal contraindications of PBCC: anterior placenta praevia, placental
abruption
- High urgency caesarean section, with intended interval to delivery less than
15 min
- Cases that have undergone antenatal experimental medical therapy aiming to
decrease the occurrence of pulmonary hypertension (such as sildenafil)
- A twin pregnancy with one of the fetuses diagnosed with CDH infant and that
infant is first born either vaginally or via caesarean section
- Multiple birth > 2 (triplets or higher order)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pulmonary hypertension diagnosed between 12-24hrs after birth via<br /><br>echocardiography.</p><br>