Inhaled Prostaglandin E1 (IPGE1) for Hypoxemic Respiratory Failure (NHRF)

This study has been terminated.
(The study was halted due to futility concerns based on the unmet benchmarks as specified in the pilot study protocol.)
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network
ClinicalTrials.gov Identifier:
NCT01467076
First received: October 17, 2011
Last updated: November 3, 2016
Last verified: November 2016
Results First Received: November 3, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Prematurity
Respiratory Insufficiency
Pulmonary Hypertension
Respiratory Distress Syndrome, Newborn
Interventions: Drug: Aerosolized Normal Saline
Drug: Inhaled PGE1

  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
Opened for recruitment on 10/20/2011. There was a lag of 33 to 90 days between IRB approval and site readiness to enroll patients. 46 infants were screened at 8 sites, 14 met eligibility criteria, and 7 were randomized. Enrollment was halted for lack of feasibility in mid-May 2012; at that time, only 7 patients had been enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seven eligible infants were not enrolled because parents were unavailable or refused consent for 3 of the infants, 3 infants met ECMO criteria, and 1 had cardio-respiratory arrest.

Reporting Groups
  Description
Control Aerosolized saline
Low Dose IPGE1 150 ng/kg/min
High Dose IPGE1 300 ng/kg/min

Participant Flow:   Overall Study
    Control   Low Dose IPGE1   High Dose IPGE1
STARTED   3   2   2 
COMPLETED   2   2   2 
NOT COMPLETED   1   0   0 
Lost to Follow-up                1                0                0 



  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.

Infants randomized to the Control group were given the placebo dose.

Infants randomized to the Low Dose IPGE1 were given the lower dose.

Infants randomized to the High Dose IPGE1 were given the higher dose.


Reporting Groups
  Description
Control Aerosolized saline
Low Dose IPGE1 150 ng/kg/min
High Dose IPGE1 300 ng/kg/min
Total Total of all reporting groups

Baseline Measures
   Control   Low Dose IPGE1   High Dose IPGE1   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   2   2   7 
Age, Customized 
[Units: Hours]
Mean (Full Range)
       
Age at Randomization   41.75 
 (27.80 to 58.33) 
 11.30 
 (7.10 to 15.50) 
 26.65 
 (10.28 to 43.03) 
 28.73 
 (7.10 to 58.33) 
Gender 
[Units: Participants]
Count of Participants
       
Female      1  33.3%      1  50.0%      2 100.0%      4  57.1% 
Male      2  66.7%      1  50.0%      0   0.0%      3  42.9% 
Birthweight 
[Units: Grams]
Mean (Full Range)
 3591 
 (2880 to 3965) 
 3530 
 (3470 to 3590) 
 3320 
 (3103 to 3537) 
 3496 
 (2880 to 3965) 
Delivery by Cesarean Section 
[Units: Participants]
 2   2   1   5 
Intubation in Delivery Room 
[Units: Participants]
 0   2   2   4 


  Outcome Measures

1.  Primary:   Assess Feasibility to Recruit at Least 50 Infants   [ Time Frame: 9 months after 75% of the participating sites are enrolling ]

2.  Secondary:   Improvement in Partial Pressure of Oxygen in the Blood (PaO2)   [ Time Frame: 72 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Improvement in Oxygenation Index (OI)   [ Time Frame: 72 Hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Need for INO 72 Hours After INO   [ Time Frame: 72 hours after INO ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Duration of iNO Therapy   [ Time Frame: Until death or hospital discharge, up to one year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Death   [ Time Frame: Up to one year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Need for Extracorporeal Membrane Oxygenation (ECMO)   [ Time Frame: Until death or hospital discharge, up to one year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Duration of Mechanical Ventilation   [ Time Frame: Until death or hospital discharge, up to on year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Number of Days of Oxygen (O2) Used, and Need for Supplemental Oxygen (O2)   [ Time Frame: 28 Days of LIfe ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Length of Hospital Stay   [ Time Frame: Up to one year ]
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
No text entered.


  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: Beena Sood, M.D.
Organization: Wayne State University
phone: 313-745-5638
e-mail: bsood@med.wayne.edu


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

Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT01467076     History of Changes
Other Study ID Numbers: NICHD-NRN-0046
U10HD040689 ( US NIH Grant/Contract Award Number )
U10HD021385 ( US NIH Grant/Contract Award Number )
U10HD027904 ( US NIH Grant/Contract Award Number )
U10HD027880 ( US NIH Grant/Contract Award Number )
U10HD034216 ( US NIH Grant/Contract Award Number )
U10HD040492 ( US NIH Grant/Contract Award Number )
U10HD053109 ( US NIH Grant/Contract Award Number )
U10HD040461 ( US NIH Grant/Contract Award Number )
U10HD068263 ( US NIH Grant/Contract Award Number )
U10HD068270 ( US NIH Grant/Contract Award Number )
U10HD068278 ( US NIH Grant/Contract Award Number )
U10HD036790 ( US NIH Grant/Contract Award Number )
Study First Received: October 17, 2011
Results First Received: November 3, 2016
Last Updated: November 3, 2016