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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Very Low Birth Weight Infant, Placental Transfusion, Anemia

Intervention / Treatment
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* Procedure: Extrauterine placental transfusion (Intervention group)
* Procedure: Delayed cord clamping (Control group)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extrauterine Placental Transfusion EPT<br>Intervention group | Procedure: Extrauterine placental transfusion (Intervention group)<br>* 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.<br>|
| Active Comparator: Delayed cord clamping DCC<br>Control group | Procedure: Delayed cord clamping (Control group)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematocrit | Mean Hematocrit in the first 24 hours of life | 0 - 24 hours of life | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extrauterine placental transfusion, delayed cord clamping, neonatal resuscitation