Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants

Phase 3

• Conditions: Intraventricular Haemorrhage Neonatal
• Interventions: Drug: Dextrose 5; Drug: Acetaminophen

• Registration Number: NCT03024814
• Lead Sponsor: King Saud Medical City

Brief 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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-14
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-14
• Last Update Submitted: 2017-01-14
• Study First Posted: 2017-01-19
• Last Update Posted: 2017-01-19
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group (Dextrose 5)	Dextrose 5	Babies who took placebo
acetaminophen group	Acetaminophen	Babies who took acetaminophen

Primary Outcome Measures

Name	Time	Method
The incidence of intraventricular hemorrhage (IVH will be graded by Papile score) among the infants on acetaminophen compared to the infants on placebo.	within the first week of age

Secondary Outcome Measures

Name	Time	Method
The incidence of neonatal sepsis in the premature babies who received acetaminophen	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	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	Corrected 40 weeks of gestational age or time of discharge will be used

Trial Locations

Locations (1)

Mountasser Al-Mouqdad; 🇸🇦 Riyadh, Saudi Arabia