Status:
COMPLETED
Aeration, Breathing, Clamping Study 3
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Erasmus Medical Center
Medical Research Foundation, The Netherlands
Conditions:
Preterm Infant
Birth, Preterm
Eligibility:
All Genders
Up to 29 years
Phase:
NA
Brief Summary
Delayed cord clamping (DCC) in preterm infants results in a decrease in mortality and a trend towards fewer intraventricular haemorrhages. However, preterm infants needing immediate interventions for ...
Eligibility Criteria
Inclusion
- Infants born at a gestational age below 30 weeks in a participating centre.
- Parental consent (see 9.2).
Exclusion
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Significant congenital malformations influencing cardiopulmonary transition.
- Signs of acute placental abruption.
- Anterior placenta praevia or invasive placentation (accreta/percreta).
- Birth by emergency caesarean section (ordered to be executed within 15 minutes).
- Maternal general anaesthesia during caesarean section.
- 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.
- In case of twin delivery by caesarean section it is not possible to perform PBCC in both infants. Both infants will be included: the first infant will receive standard treatment and the second infant will be randomised to either PBCC or standard treatment.
Key Trial Info
Start Date :
January 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
689 Patients enrolled
Trial Details
Trial ID
NCT03808051
Start Date
January 25 2019
End Date
May 1 2025
Last Update
November 25 2025
Active Locations (10)
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1
Amsterdam University Medical Centre, location AMC
Amsterdam, Netherlands
2
Amsterdam University Medical Centre, location VU
Amsterdam, Netherlands
3
University Medical Centre Groningen
Groningen, Netherlands
4
Leiden University Medical Centre
Leiden, Netherlands