Randomized Controlled Trial for the Prevention of Intraventricular Hemorrhage by Indomethacin in Japanese Extremely Low Birth Weight Infants.

UMIN ID: C000000160

Registered date:11/09/2005

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Extremely Low Birth Weight Infants (Intraventricular Hemorrhage , Patent ductus arteriosus)
• Date of first enrollment: 1999/11/01
• Target sample size: 600
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A dose of intravenous injection of 0.1 mg /kg of indomethacin will be given continuously in 6 hours. Two additional dose will be given in the same manner in every 24 hours. Administration will be completed when the third administration is completed.
Placebo (A same dose of intravenous indomethacin of 0.1 mg /kg) will be given continuously in 6 hours. Two additional dose will be given in the same manner in every 24 hours. Administration will be completed when the third administration is completed.

Outcome(s)

• Primary Outcome: 1. Incidence of grade 3, 4 Intraventricular hemorrhage on day 6. 2. Incidence of Patent ductus arteriosus on day 6. 3. Incidence of Periventricular Leukomalacia, Necrotizing Enterocolitis, Retinopathy of prematurity
• Secondary Outcome: 1.Developmental impairment at 1 and a half year old. 2.Developmental impairment at 3 years of age. 3.Mortality rate at 0-27 days after birth. 4.Requirement of surgery for Patent ductus arteriosus.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 0weeks-old
• Gender: Male and Female
• Exclude criteria: 1. Subjects diagnosed as grade 3 and 4 Intraventricular hemorrhage. 2. Subjects with Patent ductus arteriosus which requires the usual treatment. 3.Subjects with hemorrhage tendency. 4.Subjects with platelet count < 50,000/mm3. 5.Subjects with necrotizing enterocolitis 6.Subjects with significant birth defects. 7.Subjects with mother given indomethacin or PG inhibitor within 48hours before delivery 8. Subjects judged by the investigator to be inappropriate as study subjects.

Related Information

• Primary Sponsor: Neonatal Research Network Japan
• Source(s) of Monetary Support: Government