Clinical trial NCT03916159: Extrauterine Placental Transfusion In Neonatal Resuscitation Of Very Low Birth Weight Infants
Official title: Extrauterine Placental Transfusion In Neonatal Resuscitation (EXPLAIN) of Very Low Birth Weight Infants (VLBW): A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Very Low Birth Weight Infant
Placental Transfusion
Anemia
Keywords: extrauterine placental transfusion
delayed cord clamping
neonatal resuscitation
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 24
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hematocrit
timeFrame: 0 - 24 hours of life
Secondary outcomes:
measure: Cerebral tissue oxygen saturation
timeFrame: During first hour of life
measure: Mean airway pressure
timeFrame: During first hour of life
measure: Mean tidal volume
timeFrame: During first hour of life
measure: Heart rate
timeFrame: During first hour of life
measure: Blood oxygen saturation
timeFrame: During first hour of life
measure: Admission temperature
timeFrame: Admission to ward is up to 120 minutes of age
measure: All Grade Intraventricular Hemorrhage (IVH)
timeFrame: Up to 28 days of life
measure: All Grade BPD
timeFrame: At the corrected age of 36 weeks
measure: Spontaneous Pneumothorax/Pneumoperitoneum
timeFrame: During the first 7 days of life
measure: Spontaneous Pneumothorax/Pneumoperitoneum
timeFrame: Between day 7 and day 28 of life
measure: NEC/SIP with surgery
timeFrame: During the first 28 days of life
measure: Retinopathy of Prematurity (ROP), higher grades
timeFrame: At the corrected age of 40 weeks
measure: Death
timeFrame: Until corrected age of 40 weeks
measure: Number of participants who received red blood cell (RBC) transfusion
timeFrame: During the first 7 days of life
measure: Hyperbilirubinemia
timeFrame: During the first 14 days of life
measure: Blood Exchange Transfusion
timeFrame: During the first 14 days of life
measure: Intubation and Mechanical Ventilation
timeFrame: During the first 72 hours of life
measure: Intubation and Mechanical Ventilation
timeFrame: During hospitalization
measure: Neurodevelopmental Outcome
timeFrame: 22-26 month corrected gestational age
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne, Department of pediatrics
Study officials:
affiliation: University hospital of Cologne, Department of Pediatrics
name: André Oberthuer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuehne B, Kirchgaessner C, Becker I, Kuckelkorn M, Valter M, Kribs A, Oberthuer A. Mask Continuous Positive Airway Pressure Therapy with Simultaneous Extrauterine Placental Transfusion for Resuscitation of Preterm Infants - A Preliminary Study. Biomed Hub. 2018 Jun 26;3(2):1-10. doi: 10.1159/000488926. eCollection 2018 May-Aug.
citation: Kuehne B, Gruttner B, Hellmich M, Hero B, Kribs A, Oberthuer A. Extrauterine Placental Perfusion and Oxygenation in Infants With Very Low Birth Weight: A Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2340597. doi: 10.1001/jamanetworkopen.2023.40597.