Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laura R. Ment, Yale University
ClinicalTrials.gov Identifier:
NCT00033917
First received: April 12, 2002
Last updated: February 20, 2013
Last verified: February 2013
Results First Received: January 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Intraventricular Hemorrhage (IVH)
Bleeding in the Brain
Prematurity
Very Low Birth Weight Infants
Interventions: Drug: indomethacin
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
Preterm neonates of 600 - 1250 g birth weight were enrolled between 6 and 12 postnatal hours at Yale New Haven Hospital (New Haven, CT), Maine Medical Center (Portland, ME) and Women and Infants' Hospital (Providence, RI).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Cranial ultrasounds were performed on all study participants between 6 - 12 hours of age for group assignment. Subjects with major congenital cerebral malformations were excluded.

Reporting Groups
  Description
IVH Negative Indomethacin Those subjects with no evidence for intraventricular hemorrhage (IVH) at 6 - 12 postnatal hours. These subjects were randomized to early low-dose indomethacin (0.1 mg/kg/d for 3 doses).
IVH Negative Placebo These subjects also had no evidence for IVH at 6 - 12 hours. They were randomized to an equal volume of placebo.

Participant Flow:   Overall Study
    IVH Negative Indomethacin     IVH Negative Placebo  
STARTED     209     222  
COMPLETED     209     222  
NOT COMPLETED     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.
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Reporting Groups
  Description
Indomethacin subjects randomized to early low dose indomethacin
Placebo Group randomized to an equal volume of placebo
Total Total of all reporting groups

Baseline Measures
    Indomethacin     Placebo     Total  
Number of Participants  
[units: participants]
  209     222     431  
Age [1]
[units: hours]
Mean ± Standard Deviation
  7.8  ± 2.3     7.9  ± 2.4     7.8  ± 2.3  
Gender  
[units: participants]
     
Female     93     103     196  
Male     116     119     235  
Region of Enrollment  
[units: participants]
     
United States     209     222     431  
[1] Age is expressed in postnatal hours



  Outcome Measures
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1.  Primary:   IVH at 5 Postnatal Days   [ Time Frame: at 5 days ]

2.  Secondary:   Language Outcome   [ Time Frame: at 8 years ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Laura Ment
Organization: Yale University School of Medicine
phone: 203-785-5708
e-mail: laura.ment@yale.edu


Publications:


Responsible Party: Laura R. Ment, Yale University
ClinicalTrials.gov Identifier: NCT00033917     History of Changes
Other Study ID Numbers: R01NS27116
Study First Received: April 12, 2002
Results First Received: January 8, 2013
Last Updated: February 20, 2013
Health Authority: United States: Federal Government