Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants

NCT ID: NCT03024814

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-10-31

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.

Conditions

Intraventricular Haemorrhage Neonatal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

acetaminophen group

Babies who took acetaminophen

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

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.

Placebo group (Dextrose 5)

Babies who took placebo

Group Type: EXPERIMENTAL

Dextrose 5

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Paracetamol; Dextrose 5%

Eligibility Criteria

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

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Saud Medical City

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mountasser Al-Mouqdad

NICU consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mountasser Al-Mouqdad, MD

Role: PRINCIPAL_INVESTIGATOR

King Saud Medical City

Locations

Mountasser Al-Mouqdad

Riyadh, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Mountasser Al-Mouqdafd, MD

Role: CONTACT

m.almouqdad@ksmc.med.sa

00966539095090

Facility Contacts

Mountasser Al-Mouqdad, MD

Role: primary

m.almouqdad@ksmc.med.sa

00966539095090

Other Identifiers

HRC-09-Nov15-02

Identifier Type: -

Identifier Source: org_study_id