Extreme prematurity (gestational age 22+0–27+6 weeks) with risk for major neonatal morbidities (IVH, BPD, NEC, ROP, cPVL).
Conditions
Interventions
Group 1: STARTbeforeCORT (SBC): Start of respiratory stabilization before umbilical cord transfusion in preterm infants 22+0–27+6 weeks’ gestation.
Group 2: Delayed Cord Clamping (DCC): Delayed clampi
Sponsors
Universitätsklinikum Ulm, Klinik für Kinder-und Jugendmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Preterm infants born between 22+0 and 27+6 weeks’ gestation Birth till max. 1 hour after birth (time window for study inclusion) Written informed consent of parents or legal guardian
Exclusion criteria
Exclusion criteria: Spontaneous vaginal delivery Emergency delivery with insufficient time for informed consent Non-lastborn multiple Severe congenital malformations (neurological, pulmonary, cardiac) Decision for palliative care only Parents unable to understand study information due to language barriers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of any acute severe morbidity (IVH > grade 2, cPVL, NEC > stage 1, moderate/severe BPD, or ROP > stage 2) until discharge or 36 weeks’ postmenstrual age, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Very early and early mortality, individual severe morbidities (IVH, cPVL, NEC, BPD, ROP), need for resuscitation, intubation, transfusions, circulatory therapy, duration of oxygen and respiratory support, somatic growth, neurodevelopmental and psychomotor outcome at 24 and 60 months corrected age, quality of life (PedsQL), social participation (YC-PEM), pulmonary health (ASQ3 questionnaires). | — |
Countries
Germany
Contacts
Public ContactHarald Ehrhardt
Universitätsklinik Ulm, Klinik für Kinder- und Jugendmedizin
Outcome results
None listed