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

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

Patrocinadores

Patrocinador principal: Yale University

Fuente Yale University
Resumen breve

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

Descripción detallada

Intraventricular hemorrhage (IVH) or bleeding in the brain remains a major problem of preterm infants. This randomized, placebo-controlled multicenter trial enrolled 505 infants of 600 to 1250g birth weight to determine if indomethacin lowers the incidence of IVH, and 125 term infant controls. During this longitudinal trial, follow-up assessments have been performed at the ages of 3, 4 1/2, 6, 8, 12 and 16 years. The initial results at age 3 years revealed no advantages to the indomethacin group over and above the decreases in IVH, however, the results did show a significant increase in ventriculomegaly in the "placebo" group. Results at 4 1/2, 6 and 8 years of age showed beneficial effects of indomethacin on cognitive and behavioral outcomes over and above the effects on preventing IVH but not at later ages. At 12 and 16 years, no significant influence of indomethacin on cognitive outcome was noted.

Age, gender and zip-code matched control subjects were added when the preterm subjects were 8 years. Throughout all subsequent testing, term controls have higher IQ and Peabody Picture Vocabulary Scores.

Additional longitudinal volumetric, functional and diffusion tensor MR imaging studies showed differences between preterm and term control subjects at 8, 12 and 16 years of age. These were consistent with utilization of the right hemisphere and left cerebellum for language in the preterm group compared to term controls. No effects of indomethacin were seen.

The study closed on 31 March 2012.

Estado general Completed
Fecha de inicio September 1989
Fecha de Terminación March 2012
Fecha de finalización primaria March 2012
Fase Phase 3
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
IVH at 5 Postnatal Days at 5 days
Resultado secundario
Medida Periodo de tiempo
Language Outcome at 8 years
Inscripción 630
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: indomethacin

Descripción: an anti-inflammatory drug

Etiqueta de grupo de brazo: 1

Tipo de intervención: Drug

Nombre de intervención: placebo

Descripción: saline

Etiqueta de grupo de brazo: 2

Elegibilidad

Criterios:

- 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

Género: All

Edad mínima: N/A

Edad máxima: 6 Hours

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Laura R. Ment, M.D. Principal Investigator Department of Pediatrics, Yale University School of Medicine
Ubicación
Instalaciones:
Yale University School of Medicine | New Haven, Connecticut, United States
Maine Medical Center | Portland, Maine, United States
Brown University School of Medicine | Providence, Rhode Island, United States
Ubicacion Paises

United States

Fecha de verificación

February 2013

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Yale University

Nombre completo del investigador: Laura R. Ment

Título del investigador: Professor Pediatrics and Neurology

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: 1

Tipo: Active Comparator

Descripción: indomethacin

Etiqueta: 2

Tipo: Placebo Comparator

Descripción: placebo

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Prevention

Enmascaramiento: Double (Participant, Investigator)

Fuente: ClinicalTrials.gov