NCT02231411CompletedNot Applicable
Neonatal Resuscitation With Intact Cord
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sharp HealthCare
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Peak Hematocrit
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 23 Weeks to 31 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Peak Hematocrit
Time Frame: within 24 hours
Secondary Outcomes
- Use of cardiac inotropes (dopamine, dobutamine, epinephrine) (yes/no) hypotension(over the first 72 hours)
- 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)
- Admission temperatures (degree Centigrade)(within 1 hour of life)
- 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)
- 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)
- 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)
- 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)
- 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)
- Color Doppler diameter of inter-atrial shunt (mm)(6 hours of life)
- 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)
- Time of the resuscitation (minutes)(up to 30 minutes of life)
- Maximum End Tidal CO2 (mm Hg)(up to 30 minutes of life)
- SVC Flow (ml/kg/min)(target time 6 hours of life)
- Right ventricular output (ml/kg/min)(6 hours of life)
- 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)
- 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)
Investigators
Anup Katheria, M.D.
Director Neonatal Research Institute
Sharp HealthCare
Study Sites (2)
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