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

Universitätsklinikum Köln

Status: Completed

Conditions: Anemia; Very Low Birth Weight Infant; Placental Transfusion

Treatments: Procedure: Delayed cord clamping (Control group); Procedure: Extrauterine placental transfusion (Intervention group)

Study type: Interventional

Funder types: Other

Identifiers

NCT03916159

18-232

DRKS00017041 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 24+ weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Extrauterine Placental Transfusion EPT

Experimental group

Description:

Intervention group

Treatment:

Procedure: Extrauterine placental transfusion (Intervention group)

Delayed cord clamping DCC

Active Comparator group

Description:

Control group

Treatment:

Procedure: Delayed cord clamping (Control group)