Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants

King Saud Medical City

Status and phase: Unknown; Phase 3

Conditions: Intraventricular Haemorrhage Neonatal

Treatments: Drug: Dextrose 5; Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT03024814

HRC-09-Nov15-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 1 hour to 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups

acetaminophen group

Experimental group

Description:

Babies who took acetaminophen

Treatment:

Drug: Acetaminophen

Placebo group (Dextrose 5)

Experimental group

Description:

Babies who took placebo

Treatment:

Drug: Dextrose 5