Physiological-based cord clamping in preterm infants: a multicentre randomised controlled trial.
- Conditions
- Preterm infantstabilisation10028920
- Registration Number
- NL-OMON52530
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 660
Inclusion criteria in this study are:
• Infants born at a gestational age below 30 weeks in a participating centre.
• Parental consent.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Significant congenital malformations.
• Signs of acute placental abruption.
• Total placenta praevia, anterior placenta praevia or invasive placentation
(accreta/percreta).
• Birth by emergency caesarean section (ordered to be executed within 15
minutes).
• Twin gestation with signs of Twin Transfusion Syndrome or Twin Anaemia
Polycythemia Syndrome not treated with fetoscopic laser treatment.
• Multiple pregnancy > 2 (triplets or higher order).
• Decision documented to give palliative neonatal care.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The dichotomous outcome intact survival at NICU discharge is defined as<br /><br>survival without major cerebral injury (IVH >= grade 2 and/or PVL >= grade 2<br /><br>and/or periventricular venous infarction) and/or NEC >= Bell stage 2.</p><br>
- Secondary Outcome Measures
Name Time Method