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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2023-10-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Very Low Birth Weight Infant Placental Transfusion Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Extrauterine Placental Transfusion EPT

Intervention group

Group Type EXPERIMENTAL

Extrauterine placental transfusion (Intervention group)

Intervention Type PROCEDURE

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.

Delayed cord clamping DCC

Control group

Group Type ACTIVE_COMPARATOR

Delayed cord clamping (Control group)

Intervention Type PROCEDURE

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.

Interventions

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Extrauterine placental transfusion (Intervention 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.

Intervention Type PROCEDURE

Delayed cord clamping (Control group)

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

24 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No