Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants

NCT03024814 | Unknown Phase 3 DMC

• 1 other identifier: HRC-09-Nov15-02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraventricular Haemorrhage Neonatal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

acetaminophen group

EXPERIMENTAL

Babies who took acetaminophen

Drug: Acetaminophen

Placebo group (Dextrose 5)

EXPERIMENTAL

Babies who took placebo

Drug: Dextrose 5

Interventions

Acetaminophen 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.

Also known as: Paracetamol

acetaminophen group

Dextrose 5 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.

Also known as: Dextrose 5%

Placebo group (Dextrose 5)

Eligibility Criteria

• Age: 1 Hour - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature baby less than or equal 32 week and birth weight less than or equal 1500 g

You may not qualify if:

• Out-born babies, infants with major congenital anomalies, babies have IVH III, IV, High expectancy of early death

Sponsors & Collaborators

• King Saud Medical City: lead

Study Sites (1)

Mountasser Al-Mouqdad

Riyadh, 11196, Saudi Arabia

RECRUITING

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mountasser Al-Mouqdad, MD

  King Saud Medical City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mountasser Al-Mouqdafd, MD

CONTACT

00966539095090; m.almouqdad@ksmc.med.sa

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NICU consultant

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: January 19, 2017
• Study Start: October 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 19, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)