Anemia Clinical Trial
— EXPLAINOfficial title:
Extrauterine Placental Transfusion In Neonatal Resuscitation (EXPLAIN) of Very Low Birth Weight Infants (VLBW): A Randomized Clinical Trial
Verified date | November 2023 |
Source | Universitätsklinikum Köln |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital of Cologne, Department of pediatrics | Cologne |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Köln |
Germany,
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
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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