CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Extrauterine placental transfusion (Intervention group) +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03916159
NCT03916159N/ACompleted
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Extrauterine Placental Transfusion In Neonatal Resuscitation (EXPLAIN) of Very Low Birth Weight Infants (VLBW): A Randomized Clinical Trial

Universitätsklinikum Köln·interventional·Posted Apr 16, 2019·Updated Nov 8, 2023

In Brief

A clinical study evaluating Extrauterine placental transfusion (Intervention group) and Delayed cord clamping (Control group) for Very Low Birth Weight Infant and 2 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVery Low Birth Weight Infant, Placental Transfusion, Anemia
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 16, 2019
Enrollment StartMay 1, 2019
Primary CompletionDec 5, 2021
Study CompletionOct 24, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.2 years ago

Interventions

Extrauterine placental transfusion (Intervention group)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 (Control group)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.