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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00033917
Recruitment Status : Completed
First Posted : April 15, 2002
Results First Posted : March 28, 2013
Last Update Posted : March 28, 2013
Information provided by (Responsible Party):
Laura R. Ment, Yale University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions: Intraventricular Hemorrhage (IVH)
Bleeding in the Brain
Very Low Birth Weight Infants
Interventions: Drug: indomethacin
Drug: placebo

  Participant Flow

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
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 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 209   222   431 
Age [1] 
[Units: Hours]
Mean (Standard Deviation)
 7.8  (2.3)   7.9  (2.4)   7.8  (2.3) 
[1] Age is expressed in postnatal hours
[Units: Participants]
Female   93   103   196 
Male   116   119   235 
Region of Enrollment 
[Units: Participants]
United States   209   222   431 

  Outcome Measures

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

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

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


Responsible Party: Laura R. Ment, Yale University Identifier: NCT00033917     History of Changes
Other Study ID Numbers: R01NS027116 ( U.S. NIH Grant/Contract )
First Submitted: April 12, 2002
First Posted: April 15, 2002
Results First Submitted: January 8, 2013
Results First Posted: March 28, 2013
Last Update Posted: March 28, 2013