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Prophylactic Phenobarbital After Neonatal Seizures (PROPHENO)

This study has been terminated.
(Inadequate rate of enrollment)
Sponsor:
Information provided by (Responsible Party):
Ronnie Guillet, University of Rochester
ClinicalTrials.gov Identifier:
NCT01089504
First received: March 17, 2010
Last updated: January 4, 2016
Last verified: January 2016
Results First Received: January 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Neonatal Seizures
Interventions: Drug: phenobarbital
Drug: placebo

  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
No text entered.

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
Phenobarbital

Phenobarbital, 4-5 mg/kg/day, for 4 months

phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months

Placebo

Placebo in a volume equivalent to active drug for 4 months

placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months


Participant Flow:   Overall Study
    Phenobarbital   Placebo
STARTED   8   5 
COMPLETED   5   4 
NOT COMPLETED   3   1 
Lost to Follow-up                1                1 
Withdrawal by Subject                2                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.
No text entered.

Reporting Groups
  Description
Phenobarbital

Phenobarbital, 4-5 mg/kg/day, for 4 months

phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months

Placebo

Placebo in a volume equivalent to active drug for 4 months

placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months

Total Total of all reporting groups

Baseline Measures
   Phenobarbital   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   5   13 
Age 
[Units: Participants]
     
<=18 years   8   5   13 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   5   2   7 
Male   3   3   6 
Region of Enrollment 
[Units: Participants]
     
United States   8   5   13 


  Outcome Measures
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1.  Primary:   Mean Bayley Scales of Infant Development (BSID) Score - Cognitive   [ Time Frame: 18-22 months ]

2.  Secondary:   Mean Bayley Scales of Infant Development (BSID) Score - Motor   [ Time Frame: 18-22 months ]

3.  Secondary:   Number of Participants With One or More Seizures   [ Time Frame: 18-22 months ]


  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
Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary analysis.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ronnie Guillet
Organization: University of Rochester
phone: 585-275-6209
e-mail: ronnie_guillet@urmc.rochester.edu



Responsible Party: Ronnie Guillet, University of Rochester
ClinicalTrials.gov Identifier: NCT01089504     History of Changes
Other Study ID Numbers: 28907
Study First Received: March 17, 2010
Results First Received: January 4, 2016
Last Updated: January 4, 2016
Health Authority: United States: Food and Drug Administration