Neonatal Resuscitation With Intact Cord
Not Applicable
Completed
- Conditions
- Intraventricular Hemorrhage
- Interventions
- Procedure: V-DCCProcedure: Delayed cord clampingProcedure: Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels
- Registration Number
- NCT02231411
- Lead Sponsor
- Sharp HealthCare
- Brief Summary
The purpose of this study is to examine whether providing ventilation during delayed umbilical cord clamping provides greater placental transfusion and improved hemodynamic transition at birth.
- Detailed Description
Subjects will receive 1 minute of delayed cord clamping in both arms. One arm will receive routine care, warm dry and stimulate during the 1 minutes transfusion. The second arm will receive routine care PLUS administration of CPAP and if need positive pressure ventilation. The outcome is to determine whether the addition of ventilation provides a larger placental transfusion and a smoother transition at birth.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Gestational Age: Women admitted 23+0 to 31+6 weeks (Reason: Highest risk for IVH)
Exclusion Criteria
- Gestational Age: Parents decline consent (Reason: Can only perform intervention at time of delivery)
- Congenital anomalies of newborn (Reason: Exclude the effect of abnormal hematological function)
- Placental abruption (Reason: Exclude pregnancies at risk for hemorrhage at the time of delivery)
- Twin to twin transfusion (Reason: Exclude possible loss of blood from other twin during delayed cord clamping)
- Placenta Accreta
- Prolonged premature rupture of membranes (> 2 weeks) prior to 23 weeks gestation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ventilation during DCC (V-DCC) V-DCC Measuring the volume of placental transfusion with ventilation (CPAP 5 cm H2O between inflations) in infants born by C/S or VG using, as an initial surrogate marker, Hematocrits at 12 hours of life (HOL) DCC plus dry and stimulate Delayed cord clamping Measuring the volume of placental transfusions with delayed cord clamping alone (DCC) in infants born by C/S or VD using, as an initial surrogate marker, Hematocrits at 12 hours of life (HOL) DCC plus dry and stimulate Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels Measuring the volume of placental transfusions with delayed cord clamping alone (DCC) in infants born by C/S or VD using, as an initial surrogate marker, Hematocrits at 12 hours of life (HOL)
- Primary Outcome Measures
Name Time Method Peak Hematocrit within 24 hours
- Secondary Outcome Measures
Name Time Method Positive Pressure Ventilation given 1 minute Maximum Peak Inspiratory Pressure (cm H2O) over the first 5 minutes of life Time to reach heart rate >100 beats per minute (seconds) over the first 5 minutes of life Cerebral StO2 by Near-Infrared Spectroscopy over the first 24 hours of life Fractional Oxygen Extraction by Near-Infrared Spectroscopy 24 hours of life Peak velocity of the tricuspid regurgitation jet (m/sec) (to calculate arterial pressure) 6 hours of life plus/minus 6 hours
Admission temperatures (degree Centigrade) within 1 hour of life Use of cardiac inotropes (dopamine, dobutamine, epinephrine) (yes/no) hypotension over the first 72 hours Placental Weight weighed within 24 hours of delivery of the infant Surfactant (yes/no) in DR/NICU and age (hours) up to 7 days of life Color Doppler diameter of ductus arteriosus shunt (mm) 6 hours of life plus/minus 6 hours
Duration of phototherapy days participants will be followed for the duration of hospital stay, an expected average of 48 weeks Urine output (ml/kg/day) over the first 72 hours Presence of severe intraventricular hemorrhage (Grade 3 or 4) (yes/no) 4 months or until hospital discharge Mortality (yes/no) participants will be followed for the duration of hospital stay, an expected average of 48 weeks Maternal Hemoglobin in the first 48 hours post delivery of the infant Length of umbilical cord allows use of LifeStart bed First one minute of life Evaluated by analysis of video recording
Maximum inspired oxygen (FiO2) (percentage) over the first 5 minutes of life Time oxygen saturation within and outside of target range (seconds) over the first 5 minutes of life Time to demonstrate cycling of end tidal CO2 (seconds) First minute of life Evaluated by analysis of video recording
Intubation (yes/no) in DR/NICU and age (hours) up to 7 days of life Pulsed and continuous wave Doppler assessment of inter-atrial shunt direction (% time right to left) and velocity (m/s) 6 hours of life plus/minus 6 hours
Peak total serum bilirubin (mg/dL) participants will be followed for the duration of hospital stay, an expected average of 48 weeks Serum hematocrit at birth, 12 hours, and 30 days of life Use of postnatal steroids (yes/no) 4 months or until hospital discharge Presence of intraventricular hemorrhage (yes/no) participants will be followed for the duration of hospital stay, an expected average of 48 weeks Duration of CPAP or PPV First one minute of life Evaluated by analysis of video recording
Color Doppler diameter of inter-atrial shunt (mm) 6 hours of life plus/minus 6 hours
Presence of PVL (yes/no) participants will be followed for the duration of hospital stay, an expected average of 48 weeks DR interventions after delayed cord clamping complete 10 minutes of life PPV, CPAP, intubation, chest compressions, volume, medications (yes/no)
SVC Flow (ml/kg/min) target time 6 hours of life plus/minus 6 hours
Right ventricular output (ml/kg/min) 6 hours of life plus/minus 6 hours
Cardiac Output by Electrical Cardiometry (ml/kg/min) over the first 24 hours of life Pulsed or continuous wave Doppler assessment of ductus arteriosus shunt direction (%time right to left) and velocity (m/s) 6 hours of life plus/minus 6 hours
Record Blood pressure (SBP/DBP, MAP) and whether hypotensive (defined as < GA on DOL 1) yes/no over the first 6 hours of life Arterial and venous cord pH at birth (first minute of life) Mean Arterial Blood pressure (mm Hg) over the first 24 hours Mean Airway Pressure (MAP) First 5 minutes of life Time of the resuscitation (minutes) up to 30 minutes of life Maximum End Tidal CO2 (mm Hg) up to 30 minutes of life
Trial Locations
- Locations (1)
Sharp Mary Birch Hospital for Women and Newborns
🇺🇸San Diego, California, United States