David K. Stevenson, M.D.
Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This is a study of the effects of inhaled prostaglandin E1 (PGE1) on respiratory failure (failure of the lungs to provide enough oxygen to the bloodstream) among infants born at or near term. PGE1 is naturally present in the body in small amounts and plays a role in the relaxation of blood vessels. Prostaglandins have been given to newborns for many years through a vein but that results in relaxation of blood vessels throughout the body. Some studies in animals and human adults indicate that breathing a mist containing PGE1 will target the blood vessels in the lungs and help them relax while minimizing the effects on other blood vessels in the body. A small study of PGE1 among newborns with respiratory failure identified two dose levels that seem to be effective and safe. This study will compare those two dose levels of PGE1 with standard care. Nationwide, a total of 50 infants with respiratory failure are expected to enroll in this study.
Recruiting Status:
TerminatedStanford Recruiting Status:
TerminatedCondition(s):
Intervention(s):
- Drug: inhaled Prostaglandin E1
Phase:
Phase 2Eligibility
Ages Eligible for Study:
0 hours to 168 hoursGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Gestational age ≥ 34 weeks and ≤ 7 days (168 hours) postnatal age
2. Assisted ventilation for hypoxic ventilatory failure
3. Diagnosis of HRF including perinatal aspiration syndrome (meconium, blood, or amniotic fluid),
pneumonia/sepsis, respiratory distress syndrome or idiopathic
4. An Oxygenation Index (MAP x FiO2 x 100 / PaO2) (OI) ≥ 15 and < 25 on two arterial gases at
least 15 minutes apart and no more than 12 hours apart
5. An indwelling arterial line
6. Parental consent
Key Exclusion Criteria:
1. Any infant in whom a decision has been made not to provide full treatment (e.g. chromosomal
anomalies, severe birth asphyxia)
2. Known structural congenital heart disease except patent ductus arteriosus and atrial/ventricular
level shunts
3. Congenital diaphragmatic hernia
4. Preterm neonates (< 34 weeks)
5. Thrombocytopenia (platelet count < 80,000/μl) unresponsive to platelet transfusion
6. Infants receiving hypothermia for hypoxic ischemic encephalopathy
7. Previous treatment with inhaled nitric oxide
8. Enrollment in a conflicting and/or Investigational New Drug (IND) clinical trial
Additional Study Details
Official Title:
Cooperative Multicenter Network of Neonatal Intensive Care Units: Pilot Randomized Clinical Trial of Inhaled PGE1 in Neonatal Hypoxemic Respiratory FailureAnticipated start date:
7/17/2008Lead Sponsor:
NICHDCollaborator(s):
- NICHD Neonatal Research Network
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
SafetyPrimary Outcomes:
- The ability to recruit an adequate number of patients (n = 50) in a 6-9 month period without excessive (>20%) protocol violations.
Secondary Outcomes:
- Progression to an OI greater than 25
- Improvement in partial pressure of oxygen (PaO2) in the blood gas
- Change in OI
- Death
- Need for inhaled nitric oxide or ECMO
- Length of hospitalization
- Duration of mechanical ventilation
- Number of days of oxygen used and need for supplemental oxygen at 28 days of life
- Occurrence of grade III-IV intracranial hemorrhage and cystic leukomalacia
Total Number to be Enrolled:
50Total Number to be Enrolled at Stanford:
15More Information
Secondary ID(s):
- NCT00598429
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
9/9/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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