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NCT Number: NCT03916159

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

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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Key information

Age range

24 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Cologne, Department of pediatrics

Cologne, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Hematocrit

    Time frame: 0 - 24 hours of life

    Mean Hematocrit in the first 24 hours of life

Secondary outcomes

  1. Cerebral tissue oxygen saturation

    Time frame: During first hour of life

    Transcutaneous measured cerebral tissue oxygen saturation given in percent (%) during neonatal resuscitation

  2. Mean airway pressure

    Time frame: During first hour of life

    Mean airway pressure given in cmH2O during neonatal resuscitation

  3. Mean tidal volume

    Time frame: During first hour of life

    Mean tidal volume given in milliliter (ml) during neonatal resuscitation

  4. Heart rate

    Time frame: During first hour of life

    Heart rate given in beats-per-minute (bpm) during neonatal resuscitation

  5. Blood oxygen saturation

    Time frame: During first hour of life

    Transcutaneous measured blood oxygen saturation given in percent (%) during neonatal resuscitation

  6. Admission temperature

    Time frame: Admission to ward is up to 120 minutes of age

    Mean temperature at admission

  7. All Grade Intraventricular Hemorrhage (IVH)

    Time frame: Up to 28 days of life

    Incidence of any intraventricular hemorrhage (grades 1-4)

  8. All Grade BPD

    Time frame: At the corrected age of 36 weeks

    Incidence of Bronchopulmonary Disease (BPD) (all grades)

  9. Spontaneous Pneumothorax/Pneumoperitoneum

    Time frame: During the first 7 days of life

    Early incidence of spontaneous pneumothorax and/or pneumoperitoneum

  10. Spontaneous Pneumothorax/Pneumoperitoneum

    Time frame: Between day 7 and day 28 of life

    Late incidence of spontaneous pneumothorax and/or pneumoperitoneum

  11. NEC/SIP with surgery

    Time frame: During the first 28 days of life

    Incidence of necrotizing enterocolitis (NEC) and/or spontaneous intestinal perforation (SIP) with need for surgery

  12. Retinopathy of Prematurity (ROP), higher grades

    Time frame: At the corrected age of 40 weeks

    Incidence of retinopathy of prematurity with treatment (drugs and/or surgery)

  13. Death

    Time frame: Until corrected age of 40 weeks

    Incidence of death in studied infants

  14. Number of participants who received red blood cell (RBC) transfusion

    Time frame: During the first 7 days of life

    Amount of RBC Transfusion [cumulative ml/kg over the first 7 days] in those participants who received RBC transfusion

  15. Hyperbilirubinemia

    Time frame: During the first 14 days of life

    Peak bilirubin concentration

  16. Blood Exchange Transfusion

    Time frame: During the first 14 days of life

    Incidence of blood exchange transfusion due to critical hyperbilirubinemia of the neonate.

  17. Intubation and Mechanical Ventilation

    Time frame: During the first 72 hours of life

    Incidence of intubation and time duration of mechanical ventilation

  18. Intubation and Mechanical Ventilation

    Time frame: During hospitalization

    Incidence of intubation and time duration of mechanical ventilation

  19. Neurodevelopmental Outcome

    Time frame: 22-26 month corrected gestational age

    Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III) composite score (motor, cognitive, language)

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Köln

Other

Registry information

Official study title

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

Acronym: EXPLAIN

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Apr 16, 2019
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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