Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants

King Saud Medical City300 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

300

Conditions

Intraventricular Haemorrhage Neonatal

Interventions

AcetaminophenDRUG

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.

Dextrose 5DRUG

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.

Eligibility

Sex: ALLMin age: 1 HourMax age: 6 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Premature baby less than or equal 32 week and birth weight less than or equal 1500 g Exclusion Criteria: * Out-born babies, infants with major congenital anomalies, babies have IVH III, IV, High expectancy of early death

Locations (1)

Mountasser Al-Mouqdad

Riyadh, Saudi Arabia

RECRUITING

Outcomes

Primary Outcomes

The incidence of intraventricular hemorrhage (IVH will be graded by Papile score) among the infants on acetaminophen compared to the infants on placebo.

Time frame: within the first week of age

Secondary Outcomes

The incidence of neonatal sepsis in the premature babies who received acetaminophen

Time frame: Corrected 40 weeks of gestational age or time of discharge will be used

The incidence of Necrotizing Enterocolitis (NEC) in the premature babies who received acetaminophen

Time frame: Corrected 40 weeks of gestational age or time of discharge will be used

The incidence of bronchopulmonary dysplasia (BPD) in the premature babies who received acetaminophen

Time frame: Corrected 40 weeks of gestational age or time of discharge will be used

Central Contacts

Mountasser Al-Mouqdafd, MD

CONTACT

00966539095090 m.almouqdad@ksmc.med.sa

Data from ClinicalTrials.gov

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