To evaluate the effect of acetazolamide in the prevention of intraventricular hemorrhage in preterm newborns
Phase 3
Recruiting
- Conditions
- Intracranial hemorrhage in preterm newborns.Unspecified intraventricular (nontraumatic) hemorrhage of newbornP52.3
- Registration Number
- IRCT20210607051507N3
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria
All infants admitted to the neonatal intensive care unit at Shariati and Imam Khomeini Hospitals in Tehran under the age of 34 weeks or weighing less than 1700 g in 2020-2021
According to the brain ultrasound performed, they have intraventricular hemorrhage of grade two and above
Exclusion Criteria
Syndromic cases
cases with genetic diseases
infants with metabolic and neuromuscular diseases
cyanotic heart disease
necrotizing enterocolitis
gastrointestinal bleeding
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of admission. Timepoint: Duration of hospitalization of the infant from the start of medication to complete recovery of cerebral hemorrhage and discharge. Method of measurement: Extract the date of hospitalization and discharge from the file.;Change in the degree of ventricular hemorrhage. Timepoint: within ten days and one month from the start of acetazolamide. Method of measurement: Neonatal brain ultrasound and extraction report.;Requirement of shunts. Timepoint: during of Hospitalization. Method of measurement: file review.;Seizures. Timepoint: during hospitalization. Method of measurement: file review.;Duration of use of invasive and non-invasive ventilator. Timepoint: during hospitalization. Method of measurement: file review.;Death number of neonates. Timepoint: during hospitalization. Method of measurement: file review.
- Secondary Outcome Measures
Name Time Method ephrocalcinosis. Timepoint: on one-month. Method of measurement: ultrasound sonography.;Evalution of development. Timepoint: at a modified four-month age. Method of measurement: based on ASQ.;Neonatal head circumference (examination of microcephaly or macrocephaly). Timepoint: Corrected age of three months. Method of measurement: meter(cm).;Hearing change. Timepoint: at the corrected age of three months. Method of measurement: ABR audiometer.