Status:
TERMINATED
Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Prematurity
Respiratory Insufficiency
Eligibility:
All Genders
Up to 7 years
Phase:
PHASE2
Brief Summary
This is a randomized controlled trial (RCT) on the use of Inhaled prostaglandin E1 (IPGE1) in Neonatal Hypoxemic Respiratory Failure (NHRF). Fifty patients recruited at 10 high volume sites within the...
Detailed Description
Hypoxemic respiratory failure in the newborn (NHRF) is usually associated with widespread vasoconstriction of the pulmonary microvasculature giving rise to intra- and extra-pulmonary shunts and profou...
Eligibility Criteria
Inclusion
- Gestational age less than or equal to 34 weeks
- Postnatal age less than or equal to 7 days (168 hours).
- Assisted ventilation for hypoxemic respiratory failure.
- Diagnosis of NHRF including perinatal aspiration syndrome (meconium, blood, or amniotic fluid), suspected/proven pneumonia/sepsis, respiratory distress syndrome, idiopathic persistent pulmonary hypertension of the newborn (PPHN) or suspected pulmonary hypoplasia.
- Receiving INO for at least 1 hour and not \>72 hours.
- Oxygenation Index (OI ) ≥ 15 on any 2 arterial blood gases 15 minutes to 12 hours apart while on INO.
- An indwelling arterial line is present
Exclusion
- Any infant in whom a decision has been made not to provide full treatment (e.g. chromosomal anomalies, severe birth asphyxia).
- Known structural congenital heart disease except patent ductus arteriosus and atrial/ventricular level shunts.
- Congenital diaphragmatic hernia.
- Thrombocytopenia unresponsive to platelet transfusion.
- Enrollment in a conflicting and/or Investigational New Drug (IND) clinical trial.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01467076
Start Date
November 1 2011
End Date
June 1 2012
Last Update
April 24 2019
Active Locations (11)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of California - Los Angeles
Los Angeles, California, United States, 90025
3
Stanford University
Palo Alto, California, United States, 94304
4
University of Iowa
Iowa City, Iowa, United States, 52242