Neonatal Resuscitation With Intact Cord

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neonatal Resuscitation With Intact Cord

Conditions
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Intraventricular Hemorrhage

Intervention / Treatment
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* Procedure: V-DCC
* Procedure: Delayed cord clamping
* Procedure: Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 23 Weeks
Maximum Age: 31 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 |
| --- | --- |
| Active Comparator: Ventilation during DCC (V-DCC)<br>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) | Procedure: V-DCC<br>* Ventilation with CPAP 5 cm H2O between inflations and Delayed clamping of the umbilical cord for 60 seconds<br>|
| Active Comparator: DCC plus dry and stimulate<br>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) | Procedure: Delayed cord clamping<br>* Delayed clamping of the umbilical cord for 60 seconds<br>Procedure: Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Hematocrit |  | within 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum inspired oxygen (FiO2) (percentage) |  | over the first 5 minutes of life | 
| Positive Pressure Ventilation given |  | 1 minute | 
| DR interventions after delayed cord clamping complete | PPV, CPAP, intubation, chest compressions, volume, medications (yes/no) | 10 minutes of life | 
| 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 | 
| Time oxygen saturation within and outside of target range (seconds) |  | over the first 5 minutes of life | 
| Time of the resuscitation (minutes) |  | up to 30 minutes of life | 
| Time to demonstrate cycling of end tidal CO2 (seconds) | Evaluated by analysis of video recording | First minute of life | 
| Maximum End Tidal CO2 (mm Hg) |  | up to 30 minutes of life | 
| Intubation (yes/no) in DR/NICU and age (hours) |  | up to 7 days of life | 
| Surfactant (yes/no) in DR/NICU and age (hours) |  | up to 7 days of life | 
| SVC Flow (ml/kg/min) | plus/minus 6 hours | target time 6 hours of life | 
| Right ventricular output (ml/kg/min) | plus/minus 6 hours | 6 hours of life | 
| Cardiac Output by Electrical Cardiometry (ml/kg/min) |  | over the first 24 hours 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 | 
| Color Doppler diameter of ductus arteriosus shunt (mm) | plus/minus 6 hours | 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 | 6 hours of life | 
| Color Doppler diameter of inter-atrial shunt (mm) | plus/minus 6 hours | 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 | 6 hours of life | 
| Peak velocity of the tricuspid regurgitation jet (m/sec) (to calculate arterial pressure) | plus/minus 6 hours | 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) | 
| Peak total serum bilirubin (mg/dL) |  | participants will be followed for the duration of hospital stay, an expected average of 48 weeks | 
| Duration of phototherapy days |  | 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 | 
| Admission temperatures (degree Centigrade) |  | within 1 hour of life | 
| Urine output (ml/kg/day) |  | over the first 72 hours | 
| Mean Arterial Blood pressure (mm Hg) |  | over the first 24 hours | 
| Use of cardiac inotropes (dopamine, dobutamine, epinephrine) (yes/no) hypotension |  | over the first 72 hours | 
| 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 | 
| Presence of severe intraventricular hemorrhage (Grade 3 or 4) (yes/no) |  | 4 months or until hospital discharge | 
| Presence of PVL (yes/no) |  | participants will be followed for the duration of hospital stay, an expected average of 48 weeks | 
| Mortality (yes/no) |  | participants will be followed for the duration of hospital stay, an expected average of 48 weeks | 
| Placental Weight |  | weighed within 24 hours of delivery of the infant | 
| Maternal Hemoglobin |  | in the first 48 hours post delivery of the infant | 
| Mean Airway Pressure (MAP) |  | First 5 minutes of life | 
| Duration of CPAP or PPV | Evaluated by analysis of video recording | First one minute of life | 
| Length of umbilical cord allows use of LifeStart bed | Evaluated by analysis of video recording | First one minute of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delayed Cord Clamping, Pulmonary Ventilation