Extrauterine Placental Transfusion In Neonatal Resuscitation Of Very Low Birth Weight Infants
- Conditions
- Placental TransfusionVery Low Birth Weight InfantAnemia
- Interventions
- Procedure: Delayed cord clamping (Control group)Procedure: Extrauterine placental transfusion (Intervention group)
- Registration Number
- NCT03916159
- Lead Sponsor
- Universitätsklinikum Köln
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Birth weight < 1500 gram ("very low birth weight infant")
- Delivery by caesarean section
- Gestational age > 23+6 weeks
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Delayed cord clamping DCC Delayed cord clamping (Control group) Control group Extrauterine Placental Transfusion EPT Extrauterine placental transfusion (Intervention group) Intervention group
- Primary Outcome Measures
Name Time Method Hematocrit 0 - 24 hours of life Mean Hematocrit in the first 24 hours of life
- Secondary Outcome Measures
Name Time Method Mean airway pressure During first hour of life Mean airway pressure given in cmH2O during neonatal resuscitation
Heart rate During first hour of life Heart rate given in beats-per-minute (bpm) during neonatal resuscitation
Admission temperature Admission to ward is up to 120 minutes of age Mean temperature at admission
All Grade Intraventricular Hemorrhage (IVH) Up to 28 days of life Incidence of any intraventricular hemorrhage (grades 1-4)
Cerebral tissue oxygen saturation During first hour of life Transcutaneous measured cerebral tissue oxygen saturation given in percent (%) during neonatal resuscitation
Mean tidal volume During first hour of life Mean tidal volume given in milliliter (ml) during neonatal resuscitation
Blood oxygen saturation During first hour of life Transcutaneous measured blood oxygen saturation given in percent (%) during neonatal resuscitation
All Grade BPD At the corrected age of 36 weeks Incidence of Bronchopulmonary Disease (BPD) (all grades)
Spontaneous Pneumothorax/Pneumoperitoneum Between day 7 and day 28 of life Late incidence of spontaneous pneumothorax and/or pneumoperitoneum
NEC/SIP with surgery During the first 28 days of life Incidence of necrotizing enterocolitis (NEC) and/or spontaneous intestinal perforation (SIP) with need for surgery
Retinopathy of Prematurity (ROP), higher grades At the corrected age of 40 weeks Incidence of retinopathy of prematurity with treatment (drugs and/or surgery)
Death Until corrected age of 40 weeks Incidence of death in studied infants
Number of participants who received red blood cell (RBC) transfusion 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
Hyperbilirubinemia During the first 14 days of life Peak bilirubin concentration
Blood Exchange Transfusion During the first 14 days of life Incidence of blood exchange transfusion due to critical hyperbilirubinemia of the neonate.
Intubation and Mechanical Ventilation During hospitalization Incidence of intubation and time duration of mechanical ventilation
Neurodevelopmental Outcome 22-26 month corrected gestational age Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III) composite score (motor, cognitive, language)
Trial Locations
- Locations (1)
University Hospital of Cologne, Department of pediatrics
🇩🇪Cologne, Germany