An interventional study of Extrauterine placental transfusion (Intervention group) and Delayed cord clamping (Control group) in Very Low Birth Weight Infant, Placental Transfusion and Anemia, sponsored by Universitätsklinikum Köln. Completed at 1 site in Germany. Open to participants aged 24 Weeks and older. Per ClinicalTrials.gov, last updated 2023-11-08.
Sponsored by Universitätsklinikum Köln · Not applicable, Interventional, and Prevention
To investigate the effect of extrauterine placental transfusion (EPT) compared to delayed cord clamping (DCC) on the mean hematokrit on the first day of life in very low birth weight infants (VLBW) born by caesarian section. The investigators hypothesize that EPT provides higher blood volume during neonatal transition and improves neonatal outcome of VLBW infants.
This prospective randomized controlled study will be conducted among 2 groups, all of them are preterm infants with birth weight less than 1500 g ("very low birth weight" (VLBW)) who are delivered by caesarean section, in the first interventional group an extrauterine placental transfusion (EPT) will be done during neonatal resuscitation with respiratory pressure support. There will be a delayed cord clamping (DCC) of at least 30 - 60 seconds in the control group, before starting neonatal resuscitation with respiratory support.
In EPT approach preterm born infants are delivered by caesarean section with the placenta still attached to the infant via the umbilical cord. Then, placental transfusion is performed up to several minutes by holding the placenta \~40-50cm above the babies' heart level while respiratory support by mask continuous-positive-airway-pressure (CPAP) is initiated simultaneously.
Extrauterine placental transfusion may give more blood in babies delivered by cesarean section and may improve perfusion during the fetal-to-neonatal transition with impact on neonatal outcome.
Exclusion Criteria:
Intervention group
Procedure: Extrauterine placental transfusion (Intervention group)
Control group
Procedure: Delayed cord clamping (Control group)
At delivery by caesarean section, the infant is born with the placenta still attached via the umbilical cord and placental transfusion is performed at least 1 minute but not more than 10 minutes by holding the placenta \~40-50cm above the babies' heart level while respiratory support by mask continuous-positive-airway-pressure (CPAP) is initiated simultaneously.
At delivery by caesarean section, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 30 seconds with initiation of respiratory support by mask CPAP after cord clamping.
Hematocrit
Mean Hematocrit in the first 24 hours of life
Time frame: 0 - 24 hours of life
Cerebral tissue oxygen saturation
Transcutaneous measured cerebral tissue oxygen saturation given in percent (%) during neonatal resuscitation
Time frame: During first hour of life
Mean airway pressure
Mean airway pressure given in cmH2O during neonatal resuscitation
Time frame: During first hour of life
Mean tidal volume
Mean tidal volume given in milliliter (ml) during neonatal resuscitation
Time frame: During first hour of life
Heart rate
Heart rate given in beats-per-minute (bpm) during neonatal resuscitation
Time frame: During first hour of life
Blood oxygen saturation
Transcutaneous measured blood oxygen saturation given in percent (%) during neonatal resuscitation
Time frame: During first hour of life
Admission temperature
Mean temperature at admission
Time frame: Admission to ward is up to 120 minutes of age
All Grade Intraventricular Hemorrhage (IVH)
Incidence of any intraventricular hemorrhage (grades 1-4)
Time frame: Up to 28 days of life
All Grade BPD
Incidence of Bronchopulmonary Disease (BPD) (all grades)
Time frame: At the corrected age of 36 weeks
Spontaneous Pneumothorax/Pneumoperitoneum
Early incidence of spontaneous pneumothorax and/or pneumoperitoneum
Time frame: During the first 7 days of life
Spontaneous Pneumothorax/Pneumoperitoneum
Late incidence of spontaneous pneumothorax and/or pneumoperitoneum
Time frame: Between day 7 and day 28 of life
NEC/SIP with surgery
Incidence of necrotizing enterocolitis (NEC) and/or spontaneous intestinal perforation (SIP) with need for surgery
Time frame: During the first 28 days of life
Retinopathy of Prematurity (ROP), higher grades
Incidence of retinopathy of prematurity with treatment (drugs and/or surgery)
Time frame: At the corrected age of 40 weeks
Death
Incidence of death in studied infants
Time frame: Until corrected age of 40 weeks
Number of participants who received red blood cell (RBC) transfusion
Amount of RBC Transfusion \[cumulative ml/kg over the first 7 days\] in those participants who received RBC transfusion
Time frame: During the first 7 days of life
Hyperbilirubinemia
Peak bilirubin concentration
Time frame: During the first 14 days of life
Blood Exchange Transfusion
Incidence of blood exchange transfusion due to critical hyperbilirubinemia of the neonate.
Time frame: During the first 14 days of life
Intubation and Mechanical Ventilation
Incidence of intubation and time duration of mechanical ventilation
Time frame: During the first 72 hours of life
Intubation and Mechanical Ventilation
Incidence of intubation and time duration of mechanical ventilation
Time frame: During hospitalization
Neurodevelopmental Outcome
Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III) composite score (motor, cognitive, language)
Time frame: 22-26 month corrected gestational age
Plan to share: No
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Universitätsklinikum Köln