Neonatal Resuscitation With Intact Cord

Intraventricular Hemorrhage Clinical Trial

— NRIC  

Official title:

Neonatal Resuscitation With Intact Cord

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02231411
• Other study ID #: NRIC
• Secondary ID: 5R21HD080594
• Status: Completed
• Phase: N/A
• First received: August 11, 2014
• Last updated: May 24, 2017
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: May 2017
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 31 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intraventricular Hemorrhage

Intervention

Procedure:
• V-DCC
Ventilation with CPAP 5 cm H2O between inflations and Delayed clamping of the umbilical cord for 60 seconds
• Delayed cord clamping
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

Locations

Country	Name	City	State
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Sharp HealthCare	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Hematocrit		within 24 hours
Secondary	Maximum inspired oxygen (FiO2) (percentage)		over the first 5 minutes of life
Secondary	Positive Pressure Ventilation given		1 minute
Secondary	DR interventions after delayed cord clamping complete	PPV, CPAP, intubation, chest compressions, volume, medications (yes/no)	10 minutes of life
Secondary	Maximum Peak Inspiratory Pressure (cm H2O)		over the first 5 minutes of life
Secondary	Time to reach heart rate >100 beats per minute (seconds)		over the first 5 minutes of life
Secondary	Time oxygen saturation within and outside of target range (seconds)		over the first 5 minutes of life
Secondary	Time of the resuscitation (minutes)		up to 30 minutes of life
Secondary	Time to demonstrate cycling of end tidal CO2 (seconds)	Evaluated by analysis of video recording	First minute of life
Secondary	Maximum End Tidal CO2 (mm Hg)		up to 30 minutes of life
Secondary	Intubation (yes/no) in DR/NICU and age (hours)		up to 7 days of life
Secondary	Surfactant (yes/no) in DR/NICU and age (hours)		up to 7 days of life
Secondary	SVC Flow (ml/kg/min)	plus/minus 6 hours	target time 6 hours of life
Secondary	Right ventricular output (ml/kg/min)	plus/minus 6 hours	6 hours of life
Secondary	Cardiac Output by Electrical Cardiometry (ml/kg/min)		over the first 24 hours of life
Secondary	Cerebral StO2 by Near-Infrared Spectroscopy		over the first 24 hours of life
Secondary	Fractional Oxygen Extraction by Near-Infrared Spectroscopy		24 hours of life
Secondary	Color Doppler diameter of ductus arteriosus shunt (mm)	plus/minus 6 hours	6 hours of life
Secondary	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
Secondary	Color Doppler diameter of inter-atrial shunt (mm)	plus/minus 6 hours	6 hours of life
Secondary	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
Secondary	Peak velocity of the tricuspid regurgitation jet (m/sec) (to calculate arterial pressure)	plus/minus 6 hours	6 hours of life
Secondary	Record Blood pressure (SBP/DBP, MAP) and whether hypotensive (defined as < GA on DOL 1) yes/no		over the first 6 hours of life
Secondary	Arterial and venous cord pH		at birth (first minute of life)
Secondary	Peak total serum bilirubin (mg/dL)		participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Secondary	Duration of phototherapy days		participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Secondary	Serum hematocrit		at birth, 12 hours, and 30 days of life
Secondary	Admission temperatures (degree Centigrade)		within 1 hour of life
Secondary	Urine output (ml/kg/day)		over the first 72 hours
Secondary	Mean Arterial Blood pressure (mm Hg)		over the first 24 hours
Secondary	Use of cardiac inotropes (dopamine, dobutamine, epinephrine) (yes/no) hypotension		over the first 72 hours
Secondary	Use of postnatal steroids (yes/no)		4 months or until hospital discharge
Secondary	Presence of intraventricular hemorrhage (yes/no)		participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Secondary	Presence of severe intraventricular hemorrhage (Grade 3 or 4) (yes/no)		4 months or until hospital discharge
Secondary	Presence of PVL (yes/no)		participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Secondary	Mortality (yes/no)		participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Secondary	Placental Weight		weighed within 24 hours of delivery of the infant
Secondary	Maternal Hemoglobin		in the first 48 hours post delivery of the infant
Secondary	Mean Airway Pressure (MAP)		First 5 minutes of life
Secondary	Duration of CPAP or PPV	Evaluated by analysis of video recording	First one minute of life
Secondary	Length of umbilical cord allows use of LifeStart bed	Evaluated by analysis of video recording	First one minute of life