Extrauterine Placental Transfusion In Neonatal Resuscitation (EXPLAIN) of Very Low Birth Weight Infants (VLBW): A Randomized Clinical Trial

Extrauterine Placental Transfusion In Neonatal Resuscitation (EXPLAIN) of Very Low Birth Weight Infants (VLBW): A Randomized Clinical Trial - EXPLAIN

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017041

Enrollment

Registered

2019-03-27

Start date

2019-05-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

P07.2 P61.2

Interventions

Group 1: Intervention: Extrauterine Placental Transfusion (EPT) for 1 - 10 minutes Group 2: Active control: Delayed Cord Clamping (DCC) for 30 - 180 seconds

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Birth weight 23+6 weeks

Exclusion criteria

Exclusion criteria: Vaginal delivery; Fetal or maternal risk (i.e. compromise); Congenital anomalies and/or major cardiac defects; Placental abruption or previa with hemorrhage; Placenta accreta or increta; Monochorionic multiples (i.e. Di/Mo or Mo/Mo twins); Parents declined study

Design outcomes

Primary

Measure	Time frame
Mean Hematocrit in the first 24 hours of life	—

Secondary

Measure	Time frame
2. Vital Parameters during neonatal resuscitation (Cerebral tissue oxygen saturation, mean airway pressure, mean tidal volume, heart rate, blood oxygen Saturation) [Time Frame: During first hour of life] 3. Admission temperature Mean temperature at admission [Time Frame: Admission to NICU] 4. All Grade IVH Any intraventricular hemorrhage (grades 1-4) [Time Frame: Until discharge from hospital] 5. All Grade BPD Incidence of Bronchopulmonary Disease (BPD) (all grades) [Time Frame: Until discharge from hospital] 6. Spontaneous Pneumothorax/Pneumoperitoneum Incidence of spontaneous pneumothorax and/or pneumoperitoneum [Time Frame: Until discharge from hospital] 7. NEC/SIP with surgery Incidence of necrotizing enterocolitis (NEC) and/or spontaneous intestinal perforation (SIP) with need for surgery [Time Frame: Until discharge from hospital] 8. ROP (higher grades) Incidence of retinopathy of prematurity with treatment (drugs and/or surgery) [Time Frame: Until discharge from hospital] 9. Death Incidence of death in studied infants [Time Frame: Until discharge from hospital] 10. Red blood cell transfusion Need for red blood cell transfusion [Time Frame: During first week of life (7 days)] 11. Hyperbilirubinemia Peak serum Bilirubin [Time Frame: Until discharge from hospital] 12. Blood Exchange Transfusion Incidence of blood exchange transfusion due to critical hyperbilirubinemia of the neonate. [Time Frame: Until discharge from hospital] 13. Intubation and Mechanical Ventilation Incidence of intubation and time duration of mechanical ventilation [Time Frame: Until discharge from hospital] 14. Neurodevelopmental Outcome Neurodevelopmental outcome by using the Bayley 3 composite score (motor, cognitive, language) [Time Frame: 22-26 month corrected gestational age]	—

Measure

Time frame

2. Vital Parameters during neonatal resuscitation (Cerebral tissue oxygen saturation, mean airway pressure, mean tidal volume, heart rate, blood oxygen Saturation) [Time Frame: During first hour of life] 3. Admission temperature Mean temperature at admission [Time Frame: Admission to NICU] 4. All Grade IVH Any intraventricular hemorrhage (grades 1-4) [Time Frame: Until discharge from hospital] 5. All Grade BPD Incidence of Bronchopulmonary Disease (BPD) (all grades) [Time Frame: Until discharge from hospital] 6. Spontaneous Pneumothorax/Pneumoperitoneum Incidence of spontaneous pneumothorax and/or pneumoperitoneum [Time Frame: Until discharge from hospital] 7. NEC/SIP with surgery Incidence of necrotizing enterocolitis (NEC) and/or spontaneous intestinal perforation (SIP) with need for surgery [Time Frame: Until discharge from hospital] 8. ROP (higher grades) Incidence of retinopathy of prematurity with treatment (drugs and/or surgery) [Time Frame: Until discharge from hospital] 9. Death Incidence of death in studied infants [Time Frame: Until discharge from hospital] 10. Red blood cell transfusion Need for red blood cell transfusion [Time Frame: During first week of life (7 days)] 11. Hyperbilirubinemia Peak serum Bilirubin [Time Frame: Until discharge from hospital] 12. Blood Exchange Transfusion Incidence of blood exchange transfusion due to critical hyperbilirubinemia of the neonate. [Time Frame: Until discharge from hospital] 13. Intubation and Mechanical Ventilation Incidence of intubation and time duration of mechanical ventilation [Time Frame: Until discharge from hospital] 14. Neurodevelopmental Outcome Neurodevelopmental outcome by using the Bayley 3 composite score (motor, cognitive, language) [Time Frame: 22-26 month corrected gestational age]

—

Countries

Germany

Contacts

Public ContactBenjamin Kühne

Uniklinik Köln, Klinik und Poliklinik für Kinder- und Jugendmedizin

benjamin.kuehne@uk-koeln.de0221 47885699

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 10, 2026