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

NCT03916159 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-08

No results posted yet for this study

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.

Conditions

  • Very Low Birth Weight Infant
  • Placental Transfusion
  • Anemia

Interventions

PROCEDURE

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.

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.

Sponsors & Collaborators

  • Universitätsklinikum Köln

    lead OTHER

Principal Investigators

  • André Oberthuer, MD · University hospital of Cologne, Department of Pediatrics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
24 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2021-12-05
Completion
2023-10-24

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03916159 on ClinicalTrials.gov