Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies
- Registration Number
- NCT00551642
- Lead Sponsor
- Mallinckrodt
- Brief Summary
The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy on the development of these children over 7 years of clinical follow-up.
- Detailed Description
Although the effects of inhaled Nitric Oxide on pulmonary vascular tone are well-described and relevant to term infants with persistent pulmonary hypertension, the pathophysiology of respiratory failure in preterm infants may be quite different. Chronic lung disease (CLD) represents the final pathway of a heterogeneous group of pulmonary disorders of infancy that usually start in the neonatal period. CLD most commonly occurs in preterm (\<30 weeks of gestational age (GA) infants with birth weights less than 1,500 grams (g), and especially in those very preterm (\<26 weeks GA) with birth weights less than 1,000 g, and who have been treated for respiratory distress syndrome (RDS).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
- Inborn preterm infants 24+0 weeks-28+6 days weeks gestational age (defined by first trimester ultrasound or if not available based on the last menstrual period) who requires the use of surfactant within 24 hours of birth (either prophylactically, or for signs of developing respiratory distress), or who requires the use of continuous positive airway pressure (CPAP) (fraction of inspired oxygen concentration (FiO2) ≥ 0.30 on a mean airway pressure ≥ 4cm water (H2O)) within 24 hours of birth in order to maintain an oxygen saturation (SpO2) ≥ 85%.
- Informed consent of the guardian.
- Outborn infants.
- Infants ≥ 29 weeks gestational age.
- Infants requiring FiO2 >0.5 to maintain SpO2 >85%, on a sufficient mean airway pressure (e.g., > 8 cm H2O on controlled mechanical ventilation (CMV)) in order to achieve adequate chest inflation (8-9 ribs on Chest X-ray) two hours after the proper administration of exogenous surfactant.
- Any suspected congenital heart disease other than patent ductus arteriosus or atrial septal defect.
- Any infant with severe bleeding or coagulation abnormalities at high-risk of diathesis, e.g., platelet <50,000 per millimeter cube (mm³), fibrinogen <0.5 gram per liter (g/L), other clotting factors <10%.
- Any infant in whom a decision has been made not to provide full treatment, e.g., chromosomal abnormalities, severe multiple abnormalities, severe birth asphyxia, etc.
- Use of another investigational drug or device before or during the active study period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo gas administered by nasal continuous positive airway pressure, nasal cannula or face mask, for a maximum of 21 days. Inhaled Nitric Oxide (INO) Nitric oxide INO administered by nasal continuous positive airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for between 7 and 21 days
- Primary Outcome Measures
Name Time Method Survival Without Bronchopulmonary Dysplasia (BPD) in Preterm Infants With Respiratory Distress 21 days Survival without BPD is defined as the number of preterm infants of 36 weeks gestational age who survived the treatment period without the need for supplemental oxygen
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
Clinique St. Vincent CHC
🇧🇪Rocourt, Belgium
Beatrix Children's Hospital, University Medical Center Groningen
🇳🇱Groningen, Netherlands
Policlinico S. Orsola
🇮🇹Bologna, Italy
Clinique Notre Dame
🇧🇪Charleroi, Belgium
Centre Hospitalier Intercommunal de Creteil
🇫🇷Creteil, France
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Hospital Robert Debre
🇫🇷Paris, France
Oulun yliopsistollinen sairaala
🇫🇮Oulu, Finland
Campus Charite Mitte
🇩🇪Berlin, Germany
Hospital Mere-Enfant
🇫🇷Nantes Cedex 1, France
Universitaetsklinikum Marburg
🇩🇪Marburg, Germany
Universitaeklinikum Tuebingen
🇩🇪Tuebingen, Germany
Universitaetsklinikum Muenchen
🇩🇪Muenchen, Germany
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitaetsklinikum Mannheim
🇩🇪Mannheim, Germany
Univeritaetsklinik Ulm
🇩🇪Ulm, Germany
Az. Osp. G. Salesi
🇮🇹Ancona, Italy
Ospedali Riuniti
🇮🇹Bergamo, Italy
Azienda Ospedaliera Careggi
🇮🇹Firenze, Italy
Policlinico Gemelli
🇮🇹Roma, Italy
University Padova
🇮🇹Padova, Italy
Sophia Kinderziekenhuis
🇳🇱Rotterdam, Netherlands
Hospital de Cruces
🇪🇸Barakaldo, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Gregorio Mar
🇪🇸Madrid, Spain
Hosspital Univeritario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Canarias
🇪🇸Santa Cruz de Tenerife, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Astrid Lindgrens barnsjukjus, Karolinska Unviersritets sjukhuset-Solna
🇸🇪Stockholm, Sweden
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Akademiska Sjukhuset
🇸🇪Uppsala, Sweden
Kings College
🇬🇧London, United Kingdom
Meedway Mariton Hospital
🇬🇧Gillingham, United Kingdom
UCL St. LUC
🇧🇪Bruxelles, Belgium