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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
150
Ventilation with CPAP 5 cm H2O between inflations and Delayed clamping of the umbilical cord for 60 seconds
Delayed clamping of the umbilical cord for 60 seconds
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States
Peak Hematocrit
Time frame: within 24 hours
Maximum inspired oxygen (FiO2) (percentage)
Time frame: over the first 5 minutes of life
Positive Pressure Ventilation given
Time frame: 1 minute
DR interventions after delayed cord clamping complete
PPV, CPAP, intubation, chest compressions, volume, medications (yes/no)
Time frame: 10 minutes of life
Maximum Peak Inspiratory Pressure (cm H2O)
Time frame: over the first 5 minutes of life
Time to reach heart rate >100 beats per minute (seconds)
Time frame: over the first 5 minutes of life
Time oxygen saturation within and outside of target range (seconds)
Time frame: over the first 5 minutes of life
Time of the resuscitation (minutes)
Time frame: up to 30 minutes of life
Time to demonstrate cycling of end tidal CO2 (seconds)
Evaluated by analysis of video recording
Time frame: First minute of life
Maximum End Tidal CO2 (mm Hg)
Time frame: up to 30 minutes of life
Intubation (yes/no) in DR/NICU and age (hours)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 7 days of life
Surfactant (yes/no) in DR/NICU and age (hours)
Time frame: up to 7 days of life
SVC Flow (ml/kg/min)
plus/minus 6 hours
Time frame: target time 6 hours of life
Right ventricular output (ml/kg/min)
plus/minus 6 hours
Time frame: 6 hours of life
Cardiac Output by Electrical Cardiometry (ml/kg/min)
Time frame: over the first 24 hours of life
Cerebral StO2 by Near-Infrared Spectroscopy
Time frame: over the first 24 hours of life
Fractional Oxygen Extraction by Near-Infrared Spectroscopy
Time frame: 24 hours of life
Color Doppler diameter of ductus arteriosus shunt (mm)
plus/minus 6 hours
Time frame: 6 hours of life
Pulsed or continuous wave Doppler assessment of ductus arteriosus shunt direction (%time right to left) and velocity (m/s)
plus/minus 6 hours
Time frame: 6 hours of life
Color Doppler diameter of inter-atrial shunt (mm)
plus/minus 6 hours
Time frame: 6 hours of life
Pulsed and continuous wave Doppler assessment of inter-atrial shunt direction (% time right to left) and velocity (m/s)
plus/minus 6 hours
Time frame: 6 hours of life
Peak velocity of the tricuspid regurgitation jet (m/sec) (to calculate arterial pressure)
plus/minus 6 hours
Time frame: 6 hours of life
Record Blood pressure (SBP/DBP, MAP) and whether hypotensive (defined as < GA on DOL 1) yes/no
Time frame: over the first 6 hours of life
Arterial and venous cord pH
Time frame: at birth (first minute of life)
Peak total serum bilirubin (mg/dL)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Duration of phototherapy days
Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Serum hematocrit
Time frame: at birth, 12 hours, and 30 days of life
Admission temperatures (degree Centigrade)
Time frame: within 1 hour of life
Urine output (ml/kg/day)
Time frame: over the first 72 hours
Mean Arterial Blood pressure (mm Hg)
Time frame: over the first 24 hours
Use of cardiac inotropes (dopamine, dobutamine, epinephrine) (yes/no) hypotension
Time frame: over the first 72 hours
Use of postnatal steroids (yes/no)
Time frame: 4 months or until hospital discharge
Presence of intraventricular hemorrhage (yes/no)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Presence of severe intraventricular hemorrhage (Grade 3 or 4) (yes/no)
Time frame: 4 months or until hospital discharge
Presence of PVL (yes/no)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Mortality (yes/no)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Placental Weight
Time frame: weighed within 24 hours of delivery of the infant
Maternal Hemoglobin
Time frame: in the first 48 hours post delivery of the infant
Mean Airway Pressure (MAP)
Time frame: First 5 minutes of life
Duration of CPAP or PPV
Evaluated by analysis of video recording
Time frame: First one minute of life
Length of umbilical cord allows use of LifeStart bed
Evaluated by analysis of video recording
Time frame: First one minute of life