NCT03024814

Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: King Saud Medical City · Other Government
• Sex: All
• Age: 1 Hour – 6 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether acetaminophen is effective in prevention or reducing the severity of IVH in premature infants.

Detailed description

It will be a double-blind randomized control trial, single center. The study will include neonates with a gestational age of less than or equal 32 weeks and a birth weight of less than or equal 1500 g, and will randomly assigned to two treatment groups (see below). Infants will be randomized to equal-sized groups using block randomization with blocks of four. Stratified randomization for gender and gestational age will be included in the randomized blocks. Gestational age will be divided into two categories: 23 weeks +0 day to 27 weeks +6 days, and from 28 weeks +0 day to 32 weeks +6 days. Gender (2) × gestational age (2) will give 6 strata, requiring 6 separate random number lists to achieve randomization.

Conditions

• Intraventricular Haemorrhage Neonatal

Interventions

Type	Name	Description
DRUG	Acetaminophen	The first group will receive acetaminophen as the following 1. Loading dose: 20 mg/kg in the first 12-24 hours To be diluted in D5W up to 3-5 ml and to be infused over 15 minutes. 2. Maintenance dose: 7.5 mg/kg after 6 hrs from the loading dose and to be repeat every 6 hours for 3 days.
DRUG	Dextrose 5	The second group will receive placebo (D5W) as the following 1. Loading dose: 3-5 ml in the first 12-24 hours To be infused over 15 minutes. 2. Maintenance dose: 3-5 ml after 6 hrs from the loading dose and to be repeat every 6 hours for 3 days.

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2017-01-19
• Last updated: 2017-01-19

Locations

1 site across 1 country: Saudi Arabia