Neonatal Resuscitation With Intact Cord (NRIC)

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.

Study Overview

• Status: Completed
• Conditions: Intraventricular Hemorrhage
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Sharp Mary Birch Hospital for Women and Newborns

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ventilation during DCC (V-DCC); 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; Ventilation with CPAP 5 cm H2O between inflations and Delayed clamping of the umbilical cord for 60 seconds
Active Comparator: DCC plus dry and stimulate; 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; Delayed clamping of the umbilical cord for 60 seconds; Procedure: Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sharp HealthCare
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: August 11, 2014
• First Submitted That Met QC Criteria: August 30, 2014
• First Posted (Estimate): September 4, 2014

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Pulmonary Ventilation; Delayed Cord Clamping
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: NRIC; 5R21HD080594 (U.S. NIH Grant/Contract)