Status:
WITHDRAWN
Inhaled Nitric Oxide (INO) In Hypoxic Respiratory Failure
Lead Sponsor:
Mallinckrodt
Conditions:
Hypoxic Respiratory Failure With Pulmonary Hypertension
Eligibility:
All Genders
Up to 48 years
Phase:
PHASE3
Brief Summary
This Phase 3, Double-blind, Randomized, Placebo controlled, multicenter study is to confirm the efficacy of inhaled nitric oxide for the management of hypoxic respiratory failure associated with pulmo...
Detailed Description
This trial will be a multi-center, double blind, placebo-controlled, randomized clinical trial. All mothers identified with prolonged rupture of membranes and/or oligohydramnios, and all inborn infant...
Eligibility Criteria
Inclusion
- Preterm infants who:
- Are in-born at \< 30 weeks gestational age
- Weigh 500-1250 grams
- Have hypoxic respiratory failure requiring mechanical ventilation with FiO2 \> 0.8 to maintain SaO2 ≥ 85% in the first 48 hours after birth after use of exogenous surfactant
- Have minimal parenchymal lung disease by chest X ray
Exclusion
- Preterm infants who:
- Have ten minute Apgar score \< 5
- Have life-threatening anomalies (cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any child who will not receive complete intensive care
- Have bilateral Grade IV Intraventricular Hemorrhage (IVH)
- Are dependent on right to left shunting to maintain the systemic circulation
- Have received prior iNO therapy
- Have had treatment with investigational medications
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00922532
Start Date
November 1 2009
End Date
October 1 2011
Last Update
September 9 2016
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