Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT03808051
Eligibility Criteria:
Inclusion Criteria:
* Infants born at a gestational age below 30 weeks in a participating centre.
* Parental consent (see 9.2).
Exclusion Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
29 Weeks
Study:
NCT03808051
Study Brief:
Protocol Section:
NCT03808051