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Completed

NCT Number: NCT02231411

Neonatal Resuscitation With Intact Cord

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.

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Key information

Conditions

Intraventricular Hemorrhage

Age range

23 week–31 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V-DCC

Procedure

Ventilation with CPAP 5 cm H2O between inflations and Delayed clamping of the umbilical cord for 60 seconds

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

Primary outcomes

  1. Peak Hematocrit

    Time frame: within 24 hours

Secondary outcomes

  1. Maximum inspired oxygen (FiO2) (percentage)

    Time frame: over the first 5 minutes of life

  2. Positive Pressure Ventilation given

    Time frame: 1 minute

  3. DR interventions after delayed cord clamping complete

    Time frame: 10 minutes of life

    PPV, CPAP, intubation, chest compressions, volume, medications (yes/no)

  4. Maximum Peak Inspiratory Pressure (cm H2O)

    Time frame: over the first 5 minutes of life

  5. Time to reach heart rate >100 beats per minute (seconds)

    Time frame: over the first 5 minutes of life

  6. Time oxygen saturation within and outside of target range (seconds)

    Time frame: over the first 5 minutes of life

  7. Time of the resuscitation (minutes)

    Time frame: up to 30 minutes of life

  8. Time to demonstrate cycling of end tidal CO2 (seconds)

    Time frame: First minute of life

    Evaluated by analysis of video recording

  9. Maximum End Tidal CO2 (mm Hg)

    Time frame: up to 30 minutes of life

  10. Intubation (yes/no) in DR/NICU and age (hours)

    Time frame: up to 7 days of life

  11. Surfactant (yes/no) in DR/NICU and age (hours)

    Time frame: up to 7 days of life

  12. SVC Flow (ml/kg/min)

    Time frame: target time 6 hours of life

    plus/minus 6 hours

  13. Right ventricular output (ml/kg/min)

    Time frame: 6 hours of life

    plus/minus 6 hours

  14. Cardiac Output by Electrical Cardiometry (ml/kg/min)

    Time frame: over the first 24 hours of life

  15. Cerebral StO2 by Near-Infrared Spectroscopy

    Time frame: over the first 24 hours of life

  16. Fractional Oxygen Extraction by Near-Infrared Spectroscopy

    Time frame: 24 hours of life

  17. Color Doppler diameter of ductus arteriosus shunt (mm)

    Time frame: 6 hours of life

    plus/minus 6 hours

  18. Pulsed or continuous wave Doppler assessment of ductus arteriosus shunt direction (%time right to left) and velocity (m/s)

    Time frame: 6 hours of life

    plus/minus 6 hours

  19. Color Doppler diameter of inter-atrial shunt (mm)

    Time frame: 6 hours of life

    plus/minus 6 hours

  20. Pulsed and continuous wave Doppler assessment of inter-atrial shunt direction (% time right to left) and velocity (m/s)

    Time frame: 6 hours of life

    plus/minus 6 hours

  21. Peak velocity of the tricuspid regurgitation jet (m/sec) (to calculate arterial pressure)

    Time frame: 6 hours of life

    plus/minus 6 hours

  22. 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

  23. Arterial and venous cord pH

    Time frame: at birth (first minute of life)

  24. Peak total serum bilirubin (mg/dL)

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks

  25. Duration of phototherapy days

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks

  26. Serum hematocrit

    Time frame: at birth, 12 hours, and 30 days of life

  27. Admission temperatures (degree Centigrade)

    Time frame: within 1 hour of life

  28. Urine output (ml/kg/day)

    Time frame: over the first 72 hours

  29. Mean Arterial Blood pressure (mm Hg)

    Time frame: over the first 24 hours

  30. Use of cardiac inotropes (dopamine, dobutamine, epinephrine) (yes/no) hypotension

    Time frame: over the first 72 hours

  31. Use of postnatal steroids (yes/no)

    Time frame: 4 months or until hospital discharge

  32. Presence of intraventricular hemorrhage (yes/no)

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks

  33. Presence of severe intraventricular hemorrhage (Grade 3 or 4) (yes/no)

    Time frame: 4 months or until hospital discharge

  34. Presence of PVL (yes/no)

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks

  35. Mortality (yes/no)

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 48 weeks

  36. Placental Weight

    Time frame: weighed within 24 hours of delivery of the infant

  37. Maternal Hemoglobin

    Time frame: in the first 48 hours post delivery of the infant

  38. Mean Airway Pressure (MAP)

    Time frame: First 5 minutes of life

  39. Duration of CPAP or PPV

    Time frame: First one minute of life

    Evaluated by analysis of video recording

  40. Length of umbilical cord allows use of LifeStart bed

    Time frame: First one minute of life

    Evaluated by analysis of video recording

Sponsors and collaborators

Lead sponsor

Sharp HealthCare

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: NRIC

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 4, 2014
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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