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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03916159
Other study ID # 18-232
Secondary ID DRKS00017041
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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