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

Anemia Clinical Trial

— EXPLAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916159
• Other study ID #: 18-232
• Secondary ID: DRKS00017041
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: October 24, 2023

Study information

• Verified date: November 2023
• Source: Universitätsklinikum Köln
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 24, 2023
• Est. primary completion date: December 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Birth Weight
• Body Weight
• Placental Transfusion
• Very Low Birth Weight Infant

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	University Hospital of Cologne, Department of pediatrics	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Köln

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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.20 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematocrit	Mean Hematocrit in the first 24 hours of life	0 - 24 hours of life
Secondary	Cerebral tissue oxygen saturation	Transcutaneous measured cerebral tissue oxygen saturation given in percent (%) during neonatal resuscitation	During first hour of life
Secondary	Mean airway pressure	Mean airway pressure given in cmH2O during neonatal resuscitation	During first hour of life
Secondary	Mean tidal volume	Mean tidal volume given in milliliter (ml) during neonatal resuscitation	During first hour of life
Secondary	Heart rate	Heart rate given in beats-per-minute (bpm) during neonatal resuscitation	During first hour of life
Secondary	Blood oxygen saturation	Transcutaneous measured blood oxygen saturation given in percent (%) during neonatal resuscitation	During first hour of life
Secondary	Admission temperature	Mean temperature at admission	Admission to ward is up to 120 minutes of age
Secondary	All Grade Intraventricular Hemorrhage (IVH)	Incidence of any intraventricular hemorrhage (grades 1-4)	Up to 28 days of life
Secondary	All Grade BPD	Incidence of Bronchopulmonary Disease (BPD) (all grades)	At the corrected age of 36 weeks
Secondary	Spontaneous Pneumothorax/Pneumoperitoneum	Early incidence of spontaneous pneumothorax and/or pneumoperitoneum	During the first 7 days of life
Secondary	Spontaneous Pneumothorax/Pneumoperitoneum	Late incidence of spontaneous pneumothorax and/or pneumoperitoneum	Between day 7 and day 28 of life
Secondary	NEC/SIP with surgery	Incidence of necrotizing enterocolitis (NEC) and/or spontaneous intestinal perforation (SIP) with need for surgery	During the first 28 days of life
Secondary	Retinopathy of Prematurity (ROP), higher grades	Incidence of retinopathy of prematurity with treatment (drugs and/or surgery)	At the corrected age of 40 weeks
Secondary	Death	Incidence of death in studied infants	Until corrected age of 40 weeks
Secondary	Number of participants who received red blood cell (RBC) transfusion	Amount of RBC Transfusion [cumulative ml/kg over the first 7 days] in those participants who received RBC transfusion	During the first 7 days of life
Secondary	Hyperbilirubinemia	Peak bilirubin concentration	During the first 14 days of life
Secondary	Blood Exchange Transfusion	Incidence of blood exchange transfusion due to critical hyperbilirubinemia of the neonate.	During the first 14 days of life
Secondary	Intubation and Mechanical Ventilation	Incidence of intubation and time duration of mechanical ventilation	During the first 72 hours of life
Secondary	Intubation and Mechanical Ventilation	Incidence of intubation and time duration of mechanical ventilation	During hospitalization
Secondary	Neurodevelopmental Outcome	Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III) composite score (motor, cognitive, language)	22-26 month corrected gestational age