To evaluate the effect of acetazolamide in the prevention of intraventricular hemorrhage in preterm newborns

Early use of Acetazolamide to prevent progression of Intraventricular hemorrhage in preterm newborns - A Double-Blind Randomized Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210607051507N3

Enrollment

132

Registered

2021-10-06

Start date

2021-09-06

Completion date

Unknown

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial hemorrhage in preterm newborns. Unspecified intraventricular (nontraumatic) hemorrhage of newborn

Interventions

Intervention 1: Intervention group: They receive acetazolamide at a dose of 1-3 mg per kg per oral every three hours until complete recovery from intraventricular bleeding. Intervention 2: Control gro

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Syndromic cases cases with genetic diseases infants with metabolic and neuromuscular diseases cyanotic heart disease necrotizing enterocolitis gastrointestinal bleeding

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Nephrocalcinosis. 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.	—

Measure

Time frame

Nephrocalcinosis. 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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmeneh Lamsehchi

Tehran University of Medical Sciences

lamsehchila@gmail.com00084901-021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026