Extrauterine Placental Transfusion In Neonatal Resuscitation Of Very Low Birth Weight Infants (EXPLAIN)

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

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.

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.

Transcutaneous measured cerebral tissue oxygen saturation given in percent (%) during neonatal resuscitation

Incidence of necrotizing enterocolitis (NEC) and/or spontaneous intestinal perforation (SIP) with need for surgery

Amount of RBC Transfusion [cumulative ml/kg over the first 7 days] in those participants who received RBC transfusion

Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III) composite score (motor, cognitive, language)

Inclusion Criteria: Birth weight < 1500 gram ("very low birth weight infant") Delivery by caesarean section Gestational age > 23+6 weeks Exclusion Criteria: Vaginal delivery Fetal or maternal risk (i.e. compromise, emergency c-section) 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

Kuehne B, Kirchgaessner C, Becker I, Kuckelkorn M, Valter M, Kribs A, Oberthuer A. Mask Continuous Positive Airway Pressure Therapy with Simultaneous Extrauterine Placental Transfusion for Resuscitation of Preterm Infants - A Preliminary Study. Biomed Hub. 2018 Jun 26;3(2):1-10. doi: 10.1159/000488926. eCollection 2018 May-Aug.