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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    60
  • sponsor
    Universitätsklinikum Köln
Updated on 6 February 2022
blood transfusion
cesarean section

Summary

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.

Description

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.

Details
Condition Very Low Birth Weight Infant, Placental Transfusion, Anemia
Treatment Extrauterine placental transfusion (Intervention group), Delayed cord clamping (Control group)
Clinical Study IdentifierNCT03916159
SponsorUniversitätsklinikum Köln
Last Modified on6 February 2022

Eligibility

Yes No Not Sure

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
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