Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants

Intraventricular Haemorrhage Neonatal Clinical Trial

Official title:

Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03024814
• Other study ID #: HRC-09-Nov15-02
• Status: Recruiting
• Phase: Phase 3
• First received: November 14, 2016
• Last updated: January 14, 2017
• Start date: October 2016
• Est. completion date: October 2018

Study information

• Verified date: January 2017
• Source: King Saud Medical City
• Contact: Mountasser Al-Mouqdafd, MD
• Phone: 00966539095090
• Email: m.almouqdad[@]ksmc.med.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Infant, Newborn, Diseases
• Intraventricular Haemorrhage Neonatal

Intervention

Drug:
• Acetaminophen
The first group will receive acetaminophen as the following 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. Maintenance dose: 7.5 mg/kg after 6 hrs from the loading dose and to be repeat every 6 hours for 3 days.
• Dextrose 5
The second group will receive placebo (D5W) as the following Loading dose: 3-5 ml in the first 12-24 hours To be infused over 15 minutes. Maintenance dose: 3-5 ml after 6 hrs from the loading dose and to be repeat every 6 hours for 3 days.

Locations

Country	Name	City	State
Saudi Arabia	Mountasser Al-Mouqdad	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud Medical City

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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