Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants

January 14, 2017 updated by: Mountasser Al-Mouqdad, King Saud Medical City
The purpose of this study is to determine whether acetaminophen is effective in prevention or reducing the severity of IVH in premature infants.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: acetaminophen group
Babies who took acetaminophen
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.
Other Names:
  • Paracetamol
Experimental: Placebo group (Dextrose 5)
Babies who took placebo
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.
Other Names:
  • Dextrose 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
within the first week of age

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Corrected 40 weeks of gestational age or time of discharge will be used

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud Medical City

Investigators

  • Principal Investigator: Mountasser Al-Mouqdad, MD, King Saud Medical City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

January 14, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 14, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRC-09-Nov15-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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