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Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants

Primary Purpose

Intraventricular Haemorrhage Neonatal

Status
Unknown status
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Acetaminophen
Dextrose 5
Sponsored by
King Saud Medical City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraventricular Haemorrhage Neonatal

Eligibility Criteria

1 Hour - 6 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Mountasser Al-MouqdadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

acetaminophen group

Placebo group (Dextrose 5)

Arm Description

Babies who took acetaminophen

Babies who took placebo

Outcomes

Primary Outcome Measures

The incidence of intraventricular hemorrhage (IVH will be graded by Papile score) among the infants on acetaminophen compared to the infants on placebo.

Secondary Outcome Measures

The incidence of neonatal sepsis in the premature babies who received acetaminophen
The incidence of Necrotizing Enterocolitis (NEC) in the premature babies who received acetaminophen
The incidence of bronchopulmonary dysplasia (BPD) in the premature babies who received acetaminophen

Full Information

First Posted
November 14, 2016
Last Updated
January 14, 2017
Sponsor
King Saud Medical City
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1. Study Identification

Unique Protocol Identification Number
NCT03024814
Brief Title
Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants
Official Title
Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud Medical City

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraventricular Haemorrhage Neonatal

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
acetaminophen group
Arm Type
Experimental
Arm Description
Babies who took acetaminophen
Arm Title
Placebo group (Dextrose 5)
Arm Type
Experimental
Arm Description
Babies who took placebo
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Paracetamol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dextrose 5
Other Intervention Name(s)
Dextrose 5%
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mountasser Al-Mouqdafd, MD
Phone
00966539095090
Email
m.almouqdad@ksmc.med.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mountasser Al-Mouqdad, MD
Organizational Affiliation
King Saud Medical City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mountasser Al-Mouqdad
City
Riyadh
ZIP/Postal Code
11196
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mountasser Al-Mouqdad, MD
Phone
00966539095090
Email
m.almouqdad@ksmc.med.sa

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants

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