NCT00033917

Brief Summary

The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in the brain of very low birth weight preterm infants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 1989

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1989

Completed
12.6 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2002

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 28, 2013

Completed
Last Updated

March 28, 2013

Status Verified

February 1, 2013

Enrollment Period

22.5 years

First QC Date

April 12, 2002

Results QC Date

January 8, 2013

Last Update Submit

February 20, 2013

Conditions

Intraventricular Hemorrhage (IVH)Bleeding in the BrainPrematurityVery Low Birth Weight Infants

Keywords

intraventricular hemorrhage (IVH)bleeding in the brainindomethacinprematurityvery low birth weight infants

Outcome Measures

Primary Outcomes (1)

  • IVH at 5 Postnatal Days

    Cranial ultrasounds were performed daily for the first 5 postnatal days; the main outcome measure was intraaventricular hemorrhage (IVH) at 5 days of age

    at 5 days

Secondary Outcomes (1)

  • Language Outcome

    at 8 years

Study Arms (2)

1

ACTIVE COMPARATOR

indomethacin

Drug: indomethacin

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

indomethacinDRUG

an anti-inflammatory drug

1
placeboDRUG

saline

2

Eligibility Criteria

AgeUp to 6 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
* Preterm infants \< 1250 g birth weight * Admitted to participating institution \< 6 hrs of age * No evidence for congenital malformations * Cranial US at 6 postnatal hours without evidence of Grades III - IV intraventricular hemorrhage

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Yale University School of Medicine

New Haven, Connecticut, United States

Location

Maine Medical Center

Portland, Maine, United States

Location

Brown University School of Medicine

Providence, Rhode Island, United States

Location

Related Publications (16)

  • Ment LR, Oh W, Ehrenkranz RA, Philip AG, Vohr B, Allan W, Duncan CC, Scott DT, Taylor KJ, Katz KH, et al. Low-dose indomethacin and prevention of intraventricular hemorrhage: a multicenter randomized trial. Pediatrics. 1994 Apr;93(4):543-50.

    PMID: 8134206BACKGROUND

  • Ment LR, Oh W, Ehrenkranz RA, Phillip AG, Vohr B, Allan W, Makuch RW, Taylor KJ, Schneider KC, Katz KH, et al. Low-dose indomethacin therapy and extension of intraventricular hemorrhage: a multicenter randomized trial. J Pediatr. 1994 Jun;124(6):951-5. doi: 10.1016/s0022-3476(05)83191-9.

    PMID: 8201485BACKGROUND

  • Ment LR, Vohr B, Oh W, Scott DT, Allan WC, Westerveld M, Duncan CC, Ehrenkranz RA, Katz KH, Schneider KC, Makuch RW. Neurodevelopmental outcome at 36 months' corrected age of preterm infants in the Multicenter Indomethacin Intraventricular Hemorrhage Prevention Trial. Pediatrics. 1996 Oct;98(4 Pt 1):714-8.

    PMID: 8885951BACKGROUND

  • Ment LR, Westerveld M, Makuch R, Vohr B, Allan WC. Cognitive outcome at 4 1/2 years of very low birth weight infants enrolled in the multicenter indomethacin intraventricular hemorrhage prevention trial. Pediatrics. 1998 Jul;102(1 Pt 1):159-60. doi: 10.1542/peds.102.1.159. No abstract available.

    PMID: 9714645BACKGROUND

  • Ment LR, Vohr B, Allan W, Westerveld M, Sparrow SS, Schneider KC, Katz KH, Duncan CC, Makuch RW. Outcome of children in the indomethacin intraventricular hemorrhage prevention trial. Pediatrics. 2000 Mar;105(3 Pt 1):485-91. doi: 10.1542/peds.105.3.485.

    PMID: 10699097BACKGROUND

  • Peterson BS, Vohr B, Staib LH, Cannistraci CJ, Dolberg A, Schneider KC, Katz KH, Westerveld M, Sparrow S, Anderson AW, Duncan CC, Makuch RW, Gore JC, Ment LR. Regional brain volume abnormalities and long-term cognitive outcome in preterm infants. JAMA. 2000 Oct 18;284(15):1939-47. doi: 10.1001/jama.284.15.1939.

    PMID: 11035890BACKGROUND

  • Ment LR, Vohr B, Allan W, Katz KH, Schneider KC, Westerveld M, Duncan CC, Makuch RW. Change in cognitive function over time in very low-birth-weight infants. JAMA. 2003 Feb 12;289(6):705-11. doi: 10.1001/jama.289.6.705.

    PMID: 12585948BACKGROUND

  • Ment LR, Peterson BS, Meltzer JA, Vohr B, Allan W, Katz KH, Lacadie C, Schneider KC, Duncan CC, Makuch RW, Constable RT. A functional magnetic resonance imaging study of the long-term influences of early indomethacin exposure on language processing in the brains of prematurely born children. Pediatrics. 2006 Sep;118(3):961-70. doi: 10.1542/peds.2005-2870.

    PMID: 16950986BACKGROUND

  • Ment LR, Kesler S, Vohr B, Katz KH, Baumgartner H, Schneider KC, Delancy S, Silbereis J, Duncan CC, Constable RT, Makuch RW, Reiss AL. Longitudinal brain volume changes in preterm and term control subjects during late childhood and adolescence. Pediatrics. 2009 Feb;123(2):503-11. doi: 10.1542/peds.2008-0025.

    PMID: 19171615BACKGROUND

  • Gozzo Y, Vohr B, Lacadie C, Hampson M, Katz KH, Maller-Kesselman J, Schneider KC, Peterson BS, Rajeevan N, Makuch RW, Constable RT, Ment LR. Alterations in neural connectivity in preterm children at school age. Neuroimage. 2009 Nov 1;48(2):458-63. doi: 10.1016/j.neuroimage.2009.06.046. Epub 2009 Jun 25.

    PMID: 19560547BACKGROUND

  • Luu TM, Vohr BR, Schneider KC, Katz KH, Tucker R, Allan WC, Ment LR. Trajectories of receptive language development from 3 to 12 years of age for very preterm children. Pediatrics. 2009 Jul;124(1):333-41. doi: 10.1542/peds.2008-2587.

    PMID: 19564317BACKGROUND

  • Myers EH, Hampson M, Vohr B, Lacadie C, Frost SJ, Pugh KR, Katz KH, Schneider KC, Makuch RW, Constable RT, Ment LR. Functional connectivity to a right hemisphere language center in prematurely born adolescents. Neuroimage. 2010 Jul 15;51(4):1445-52. doi: 10.1016/j.neuroimage.2010.03.049. Epub 2010 Mar 25.

    PMID: 20347043BACKGROUND

  • Mullen KM, Vohr BR, Katz KH, Schneider KC, Lacadie C, Hampson M, Makuch RW, Reiss AL, Constable RT, Ment LR. Preterm birth results in alterations in neural connectivity at age 16 years. Neuroimage. 2011 Feb 14;54(4):2563-70. doi: 10.1016/j.neuroimage.2010.11.019. Epub 2010 Nov 10.

    PMID: 21073965BACKGROUND

  • Luu TM, Vohr BR, Allan W, Schneider KC, Ment LR. Evidence for catch-up in cognition and receptive vocabulary among adolescents born very preterm. Pediatrics. 2011 Aug;128(2):313-22. doi: 10.1542/peds.2010-2655. Epub 2011 Jul 18.

    PMID: 21768322BACKGROUND

  • Constable RT, Vohr BR, Scheinost D, Benjamin JR, Fulbright RK, Lacadie C, Schneider KC, Katz KH, Zhang H, Papademetris X, Ment LR. A left cerebellar pathway mediates language in prematurely-born young adults. Neuroimage. 2013 Jan 1;64:371-8. doi: 10.1016/j.neuroimage.2012.09.008. Epub 2012 Sep 12.

    PMID: 22982585BACKGROUND

  • Reiss AL, Kesler SR, Vohr B, Duncan CC, Katz KH, Pajot S, Schneider KC, Makuch RW, Ment LR. Sex differences in cerebral volumes of 8-year-olds born preterm. J Pediatr. 2004 Aug;145(2):242-9. doi: 10.1016/j.jpeds.2004.04.031.

    PMID: 15289777BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Laura Ment
Organization
Yale University School of Medicine
laura.ment@yale.edu
203-785-5708

Study Officials

  • Laura R. Ment, M.D.

    Department of Pediatrics, Yale University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Pediatrics and Neurology

Study Record Dates

First Submitted

April 12, 2002

First Posted

April 15, 2002

Study Start

September 1, 1989

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 28, 2013

Results First Posted

March 28, 2013

Record last verified: 2013-02

Locations

US(3)