Clinical trial NCT02231411: Neonatal Resuscitation With Intact Cord
Official title: Neonatal Resuscitation With Intact Cord
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraventricular Hemorrhage
Keywords: Delayed Cord Clamping
Pulmonary Ventilation
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-09-04
Enrollment: 150
Sex: ALL
Minimum age (years): 23
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak Hematocrit
timeFrame: within 24 hours
Secondary outcomes:
measure: Maximum inspired oxygen (FiO2) (percentage)
timeFrame: over the first 5 minutes of life
measure: Positive Pressure Ventilation given
timeFrame: 1 minute
measure: DR interventions after delayed cord clamping complete
timeFrame: 10 minutes of life
measure: Maximum Peak Inspiratory Pressure (cm H2O)
timeFrame: over the first 5 minutes of life
measure: Time to reach heart rate >100 beats per minute (seconds)
timeFrame: over the first 5 minutes of life
measure: Time oxygen saturation within and outside of target range (seconds)
timeFrame: over the first 5 minutes of life
measure: Time of the resuscitation (minutes)
timeFrame: up to 30 minutes of life
measure: Time to demonstrate cycling of end tidal CO2 (seconds)
timeFrame: First minute of life
measure: Maximum End Tidal CO2 (mm Hg)
timeFrame: up to 30 minutes of life
measure: Intubation (yes/no) in DR/NICU and age (hours)
timeFrame: up to 7 days of life
measure: Surfactant (yes/no) in DR/NICU and age (hours)
timeFrame: up to 7 days of life
measure: SVC Flow (ml/kg/min)
timeFrame: target time 6 hours of life
measure: Right ventricular output (ml/kg/min)
timeFrame: 6 hours of life
measure: Cardiac Output by Electrical Cardiometry (ml/kg/min)
timeFrame: over the first 24 hours of life
measure: Cerebral StO2 by Near-Infrared Spectroscopy
timeFrame: over the first 24 hours of life
measure: Fractional Oxygen Extraction by Near-Infrared Spectroscopy
timeFrame: 24 hours of life
measure: Color Doppler diameter of ductus arteriosus shunt (mm)
timeFrame: 6 hours of life
measure: Pulsed or continuous wave Doppler assessment of ductus arteriosus shunt direction (%time right to left) and velocity (m/s)
timeFrame: 6 hours of life
measure: Color Doppler diameter of inter-atrial shunt (mm)
timeFrame: 6 hours of life
measure: Pulsed and continuous wave Doppler assessment of inter-atrial shunt direction (% time right to left) and velocity (m/s)
timeFrame: 6 hours of life
measure: Peak velocity of the tricuspid regurgitation jet (m/sec) (to calculate arterial pressure)
timeFrame: 6 hours of life
measure: Record Blood pressure (SBP/DBP, MAP) and whether hypotensive (defined as < GA on DOL 1) yes/no
timeFrame: over the first 6 hours of life
measure: Arterial and venous cord pH
timeFrame: at birth (first minute of life)
measure: Peak total serum bilirubin (mg/dL)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
measure: Duration of phototherapy days
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
measure: Serum hematocrit
timeFrame: at birth, 12 hours, and 30 days of life
measure: Admission temperatures (degree Centigrade)
timeFrame: within 1 hour of life
measure: Urine output (ml/kg/day)
timeFrame: over the first 72 hours
measure: Mean Arterial Blood pressure (mm Hg)
timeFrame: over the first 24 hours
measure: Use of cardiac inotropes (dopamine, dobutamine, epinephrine) (yes/no) hypotension
timeFrame: over the first 72 hours
measure: Use of postnatal steroids (yes/no)
timeFrame: 4 months or until hospital discharge
measure: Presence of intraventricular hemorrhage (yes/no)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
measure: Presence of severe intraventricular hemorrhage (Grade 3 or 4) (yes/no)
timeFrame: 4 months or until hospital discharge
measure: Presence of PVL (yes/no)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
measure: Mortality (yes/no)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks
measure: Placental Weight
timeFrame: weighed within 24 hours of delivery of the infant
measure: Maternal Hemoglobin
timeFrame: in the first 48 hours post delivery of the infant
measure: Mean Airway Pressure (MAP)
timeFrame: First 5 minutes of life
measure: Duration of CPAP or PPV
timeFrame: First one minute of life
measure: Length of umbilical cord allows use of LifeStart bed
timeFrame: First one minute of life
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
Study officials:
affiliation: Sharp HealthCare
name: Anup C Katheria, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.