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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT00551642
First received: October 30, 2007
Last updated: November 3, 2016
Last verified: November 2016
Results First Received: September 3, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider);   Primary Purpose: Treatment
Condition: Lung Disease
Interventions: Drug: Nitric Oxide for inhalation
Drug: Nitrogen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirty-five Medical Centers participated and enrolled a total of 800 subjects (Intent to treat population). The study allowed for a 2 year recruitment and intervention period followed by 7 years of clinical follow up.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Inhaled Nitric Oxide (NO) Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
Placebo (Nitrogen) Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days

Participant Flow:   Overall Study
    Inhaled Nitric Oxide (NO)   Placebo (Nitrogen)
STARTED   399   401 
COMPLETED   338   338 
NOT COMPLETED   61   63 
Withdrawal by Subject                2                1 
Adverse Event                15                12 
Death                33                31 
Protocol Violation                6                11 
Physician Decision                0                1 
Delivery device failure                1                3 
Inclusion/Exclusion criteria                4                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Inhaled Nitric Oxide (NO) Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
Placebo (Nitrogen) Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
Total Total of all reporting groups

Baseline Measures
   Inhaled Nitric Oxide (NO)   Placebo (Nitrogen)   Total 
Overall Participants Analyzed 
[Units: Participants]
 399   401   800 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      399 100.0%      401 100.0%      800 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Weeks]
Mean (Standard Deviation)
 26.4  (1.3)   26.6  (1.3)   26.5  (1.3) 
Gender 
[Units: Participants]
Count of Participants
     
Female      192  48.1%      181  45.1%      373  46.6% 
Male      207  51.9%      220  54.9%      427  53.4% 
Region of Enrollment 
[Units: Participants]
     
France   52   55   107 
Finland   4   4   8 
Spain   76   79   155 
Belgium   37   37   74 
Netherlands   20   20   40 
Germany   114   117   231 
United Kingdom   30   33   63 
Italy   44   34   78 
Sweden   22   22   44 


  Outcome Measures

1.  Primary:   Survival Without Bronchopulmonary Dysplasia (BPD) in Preterm Infants With Respiratory Distress   [ Time Frame: 36 weeks gestational age ]

2.  Primary:   Survival   [ Time Frame: 36 Weeks GA ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Vital Signs   [ Time Frame: Study Duration ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Arterial Oxygen Saturation by Pulse Oximetry   [ Time Frame: Study Duration ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Adverse Events   [ Time Frame: Study Duration ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Methemoglobin Level   [ Time Frame: Baseline, then 24 hours, 2-6 days, Day 7 and Day 14 of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Lawrence Hill
Organization: Mallinckrodt
phone: 908-238-6370
e-mail: lawrence.hill@mallinckrodt.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT00551642     History of Changes
Other Study ID Numbers: INOT27
EUNO, EU Preemie
Study First Received: October 30, 2007
Results First Received: September 3, 2010
Last Updated: November 3, 2016