NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000160

Registered date:11/09/2005

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

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedExtremely Low Birth Weight Infants (Intraventricular Hemorrhage , Patent ductus arteriosus)
Date of first enrollment1999/11/01
Target sample size600
Countries of recruitmentJapan
Study typeInterventional
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 Outcome1. 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 Outcome1.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 minimumNot applicable
Age maximum0weeks-old
GenderMale and Female
Include criteria1.Extremely low birth weight infants weighing more than 400 g and less than 1000 g at birth. 2.Gestation above 22 weeks 0 day at birth. 3.Birth weight standard deviation -1.99 sd. All infants born less than 24 weeks 0 day is to be included. 4.First dose to be given within 6 hours of birth. 5.Informed consent to participate to the study is obtained from the guardians.
Exclude criteria1. 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

Contact

public contact
Name Fujimura Masanori
Address 840, Murodocho, Izumi, Osaka, Japan Japan
Telephone 0725-56-1220
E-mail mfuji@mch.pref.osaka.jp
Affiliation Osaka Medical Center for Maternal and Child Health President
scientific contact
Name Fujimura Masanori
Address 840, Murodocho, Izumi, Osaka, Japan Japan
Telephone 0725-56-1220
E-mail
Affiliation Osaka Medical Center for Maternal and Child Health President