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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21HD080594 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventilation during DCC (V-DCC) | Active Comparator | 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 | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V-DCC | Procedure | Ventilation with CPAP 5 cm H2O between inflations and Delayed clamping of the umbilical cord for 60 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Hematocrit | within 24 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anup C Katheria, MD | Sharp HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Mary Birch Hospital for Women and Newborns | San Diego | California | 92123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27574999 | Derived | Katheria A, Poeltler D, Durham J, Steen J, Rich W, Arnell K, Maldonado M, Cousins L, Finer N. Neonatal Resuscitation with an Intact Cord: A Randomized Clinical Trial. J Pediatr. 2016 Nov;178:75-80.e3. doi: 10.1016/j.jpeds.2016.07.053. Epub 2016 Aug 26. |
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| ID | Term |
|---|---|
| D000087526 | Umbilical Cord Clamping |
| D003890 | Desiccation |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D002623 | Chemistry Techniques, Analytical |
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| Delayed cord clamping | Procedure | Delayed clamping of the umbilical cord for 60 seconds |
|
| Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels | Procedure |
|
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 |
| D008919 | Investigative Techniques |
| D055598 | Chemical Phenomena |