Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies

Lung Disease Clinical Trial

Official title:

The Effects of Nitric Oxide for Inhalation on the Development of Chronic Lung Disease in Pre-term Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551642
• Other study ID #: INOT27
• Secondary ID: 2004-002312-29
• Status: Completed
• Phase: Phase 3
• Start date: May 29, 2005
• Est. completion date: July 17, 2015

Study information

• Verified date: February 2021
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: July 17, 2015
• Est. primary completion date: March 16, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 26 Hours

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Lung Disease
• Lung Diseases

Intervention

Drug:
• Nitric oxide
Nitric Oxide vapour (gas) for inhalation (400 ppm)
• Placebo
Placebo gas for inhalation

Locations

Country	Name	City	State
Belgium	UCL St. LUC	Bruxelles
Belgium	Clinique Notre Dame	Charleroi
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Clinique St. Vincent CHC	Rocourt
Finland	Oulun yliopsistollinen sairaala	Oulu
France	Centre Hospitalier Intercommunal de Creteil	Creteil
France	Hospital Mere-Enfant	Nantes Cedex 1
France	Hospital Robert Debre	Paris
Germany	Campus Charite Mitte	Berlin
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Universitaetsklinikum Mannheim	Mannheim
Germany	Universitaetsklinikum Marburg	Marburg
Germany	Universitaetsklinikum Muenchen	Muenchen
Germany	Universitaeklinikum Tuebingen	Tuebingen
Germany	Univeritaetsklinik Ulm	Ulm
Italy	Az. Osp. G. Salesi	Ancona
Italy	Ospedali Riuniti	Bergamo
Italy	Policlinico S. Orsola	Bologna
Italy	Azienda Ospedaliera Careggi	Firenze
Italy	University Padova	Padova
Italy	Policlinico Gemelli	Roma
Netherlands	Beatrix Children's Hospital, University Medical Center Groningen	Groningen
Netherlands	Sophia Kinderziekenhuis	Rotterdam
Spain	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
Sweden	Astrid Lindgrens barnsjukjus, Karolinska Unviersritets sjukhuset-Solna	Stockholm
Sweden	Akademiska Sjukhuset	Uppsala
United Kingdom	Meedway Mariton Hospital	Gillingham
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Kings College	London

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Countries where clinical trial is conducted

Belgium,  Finland,  France,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality at 7-year Follow-up	Number of participants who died between 2 years and the 7-year Follow-up Period	at 7-year Follow-up
Other	Strengths and Difficulties Questionnaire Results for Participants at 7-year Follow-up	The Strengths and Difficulties Questionnaire contained 25 questions that were used to create 5 scales (ranging from 10=most normal to 0=most abnormal) for emotional symptoms, conduct problems, hyperactivity, peer problems, and (10=most abnormal, 0=most normal) for prosocial.	At 7-year Follow-up
Primary	Survival Without Bronchopulmonary Dysplasia (BPD) in Preterm Infants With Respiratory Distress	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	21 days