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Neonatal Resuscitation With Intact Cord (NRIC)

Primary Purpose

Intraventricular Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
V-DCC
Delayed cord clamping
Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels
Sponsored by
Sharp HealthCare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraventricular Hemorrhage focused on measuring Delayed Cord Clamping, Pulmonary Ventilation

Eligibility Criteria

23 Weeks - 31 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sharp Mary Birch Hospital for Women and Newborns

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ventilation during DCC (V-DCC)

DCC plus dry and stimulate

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Peak Hematocrit

Secondary Outcome Measures

Maximum inspired oxygen (FiO2) (percentage)
Positive Pressure Ventilation given
DR interventions after delayed cord clamping complete
PPV, CPAP, intubation, chest compressions, volume, medications (yes/no)
Maximum Peak Inspiratory Pressure (cm H2O)
Time to reach heart rate >100 beats per minute (seconds)
Time oxygen saturation within and outside of target range (seconds)
Time of the resuscitation (minutes)
Time to demonstrate cycling of end tidal CO2 (seconds)
Evaluated by analysis of video recording
Maximum End Tidal CO2 (mm Hg)
Intubation (yes/no) in DR/NICU and age (hours)
Surfactant (yes/no) in DR/NICU and age (hours)
SVC Flow (ml/kg/min)
plus/minus 6 hours
Right ventricular output (ml/kg/min)
plus/minus 6 hours
Cardiac Output by Electrical Cardiometry (ml/kg/min)
Cerebral StO2 by Near-Infrared Spectroscopy
Fractional Oxygen Extraction by Near-Infrared Spectroscopy
Color Doppler diameter of ductus arteriosus shunt (mm)
plus/minus 6 hours
Pulsed or continuous wave Doppler assessment of ductus arteriosus shunt direction (%time right to left) and velocity (m/s)
plus/minus 6 hours
Color Doppler diameter of inter-atrial shunt (mm)
plus/minus 6 hours
Pulsed and continuous wave Doppler assessment of inter-atrial shunt direction (% time right to left) and velocity (m/s)
plus/minus 6 hours
Peak velocity of the tricuspid regurgitation jet (m/sec) (to calculate arterial pressure)
plus/minus 6 hours
Record Blood pressure (SBP/DBP, MAP) and whether hypotensive (defined as < GA on DOL 1) yes/no
Arterial and venous cord pH
Peak total serum bilirubin (mg/dL)
Duration of phototherapy days
Serum hematocrit
Admission temperatures (degree Centigrade)
Urine output (ml/kg/day)
Mean Arterial Blood pressure (mm Hg)
Use of cardiac inotropes (dopamine, dobutamine, epinephrine) (yes/no) hypotension
Use of postnatal steroids (yes/no)
Presence of intraventricular hemorrhage (yes/no)
Presence of severe intraventricular hemorrhage (Grade 3 or 4) (yes/no)
Presence of PVL (yes/no)
Mortality (yes/no)
Placental Weight
Maternal Hemoglobin
Mean Airway Pressure (MAP)
Duration of CPAP or PPV
Evaluated by analysis of video recording
Length of umbilical cord allows use of LifeStart bed
Evaluated by analysis of video recording

Full Information

First Posted
August 11, 2014
Last Updated
May 24, 2017
Sponsor
Sharp HealthCare
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02231411
Brief Title
Neonatal Resuscitation With Intact Cord
Acronym
NRIC
Official Title
Neonatal Resuscitation With Intact Cord
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sharp HealthCare
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraventricular Hemorrhage
Keywords
Delayed Cord Clamping, Pulmonary Ventilation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ventilation during DCC (V-DCC)
Arm Type
Active Comparator
Arm Description
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)
Arm Title
DCC plus dry and stimulate
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
V-DCC
Intervention Description
Ventilation with CPAP 5 cm H2O between inflations and Delayed clamping of the umbilical cord for 60 seconds
Intervention Type
Procedure
Intervention Name(s)
Delayed cord clamping
Intervention Description
Delayed clamping of the umbilical cord for 60 seconds
Intervention Type
Procedure
Intervention Name(s)
Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels
Primary Outcome Measure Information:
Title
Peak Hematocrit
Time Frame
within 24 hours
Secondary Outcome Measure Information:
Title
Maximum inspired oxygen (FiO2) (percentage)
Time Frame
over the first 5 minutes of life
Title
Positive Pressure Ventilation given
Time Frame
1 minute
Title
DR interventions after delayed cord clamping complete
Description
PPV, CPAP, intubation, chest compressions, volume, medications (yes/no)
Time Frame
10 minutes of life
Title
Maximum Peak Inspiratory Pressure (cm H2O)
Time Frame
over the first 5 minutes of life
Title
Time to reach heart rate >100 beats per minute (seconds)
Time Frame
over the first 5 minutes of life
Title
Time oxygen saturation within and outside of target range (seconds)
Time Frame
over the first 5 minutes of life
Title
Time of the resuscitation (minutes)
Time Frame
up to 30 minutes of life
Title
Time to demonstrate cycling of end tidal CO2 (seconds)
Description
Evaluated by analysis of video recording
Time Frame
First minute of life
Title
Maximum End Tidal CO2 (mm Hg)
Time Frame
up to 30 minutes of life
Title
Intubation (yes/no) in DR/NICU and age (hours)
Time Frame
up to 7 days of life
Title
Surfactant (yes/no) in DR/NICU and age (hours)
Time Frame
up to 7 days of life
Title
SVC Flow (ml/kg/min)
Description
plus/minus 6 hours
Time Frame
target time 6 hours of life
Title
Right ventricular output (ml/kg/min)
Description
plus/minus 6 hours
Time Frame
6 hours of life
Title
Cardiac Output by Electrical Cardiometry (ml/kg/min)
Time Frame
over the first 24 hours of life
Title
Cerebral StO2 by Near-Infrared Spectroscopy
Time Frame
over the first 24 hours of life
Title
Fractional Oxygen Extraction by Near-Infrared Spectroscopy
Time Frame
24 hours of life
Title
Color Doppler diameter of ductus arteriosus shunt (mm)
Description
plus/minus 6 hours
Time Frame
6 hours of life
Title
Pulsed or continuous wave Doppler assessment of ductus arteriosus shunt direction (%time right to left) and velocity (m/s)
Description
plus/minus 6 hours
Time Frame
6 hours of life
Title
Color Doppler diameter of inter-atrial shunt (mm)
Description
plus/minus 6 hours
Time Frame
6 hours of life
Title
Pulsed and continuous wave Doppler assessment of inter-atrial shunt direction (% time right to left) and velocity (m/s)
Description
plus/minus 6 hours
Time Frame
6 hours of life
Title
Peak velocity of the tricuspid regurgitation jet (m/sec) (to calculate arterial pressure)
Description
plus/minus 6 hours
Time Frame
6 hours of life
Title
Record Blood pressure (SBP/DBP, MAP) and whether hypotensive (defined as < GA on DOL 1) yes/no
Time Frame
over the first 6 hours of life
Title
Arterial and venous cord pH
Time Frame
at birth (first minute of life)
Title
Peak total serum bilirubin (mg/dL)
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Title
Duration of phototherapy days
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Title
Serum hematocrit
Time Frame
at birth, 12 hours, and 30 days of life
Title
Admission temperatures (degree Centigrade)
Time Frame
within 1 hour of life
Title
Urine output (ml/kg/day)
Time Frame
over the first 72 hours
Title
Mean Arterial Blood pressure (mm Hg)
Time Frame
over the first 24 hours
Title
Use of cardiac inotropes (dopamine, dobutamine, epinephrine) (yes/no) hypotension
Time Frame
over the first 72 hours
Title
Use of postnatal steroids (yes/no)
Time Frame
4 months or until hospital discharge
Title
Presence of intraventricular hemorrhage (yes/no)
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Title
Presence of severe intraventricular hemorrhage (Grade 3 or 4) (yes/no)
Time Frame
4 months or until hospital discharge
Title
Presence of PVL (yes/no)
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Title
Mortality (yes/no)
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 48 weeks
Title
Placental Weight
Time Frame
weighed within 24 hours of delivery of the infant
Title
Maternal Hemoglobin
Time Frame
in the first 48 hours post delivery of the infant
Title
Mean Airway Pressure (MAP)
Time Frame
First 5 minutes of life
Title
Duration of CPAP or PPV
Description
Evaluated by analysis of video recording
Time Frame
First one minute of life
Title
Length of umbilical cord allows use of LifeStart bed
Description
Evaluated by analysis of video recording
Time Frame
First one minute of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
31 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anup C Katheria, MD
Organizational Affiliation
Sharp HealthCare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sharp Mary Birch Hospital for Women and Newborns
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27574999
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.
Results Reference
derived

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Neonatal Resuscitation With Intact Cord

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