Status:
COMPLETED
Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
Mallinckrodt
Conditions:
Respiratory Distress Syndrome in Premature Infants
Very Low Birth Weight Baby
Eligibility:
All Genders
1-2 years
Phase:
NA
Brief Summary
This study hopes to determine whether nitric oxide along with oxygen during the first 20 minutes of life in infants needing help with breathing will reduce the percentage and total exposure to oxygen ...
Detailed Description
Current Neonatal Resuscitation Program (NRP) guidelines suggest the use of supplemental oxygen up to fraction of inspired oxygen of 1.0 during neonatal resuscitation for both term and preterm newborns...
Eligibility Criteria
Inclusion
- Infants that are 25 0/7 - 31 6/7 weeks gestation
- Infants who require Continuous Positive Airway Pressure (CPAP) or Positive Pressure Ventilation ( PPV) during delivery room resuscitation.
Exclusion
- Refusal of consent
- Known complex congenital anomalies of the heart or lungs
- Known major genetic defects
- Hydrops fetalis
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01220687
Start Date
April 1 2011
End Date
May 1 2017
Last Update
August 19 2020
Active Locations (2)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
2
University of Oklahoma, Childrens Hospital
Oklahoma City, Oklahoma, United States, 73104