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Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants

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ClinicalTrials.gov Identifier: NCT03024814
Recruitment Status : Recruiting
First Posted : January 19, 2017
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
Mountasser Al-Mouqdad, King Saud Medical City

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.

Condition or disease Intervention/treatment Phase
Intraventricular Haemorrhage Neonatal Drug: Acetaminophen Drug: Dextrose 5 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants
Study Start Date : October 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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 Name: 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 Name: Dextrose 5%




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024814


Contacts
Contact: Mountasser Al-Mouqdafd, MD 00966539095090 m.almouqdad@ksmc.med.sa

Locations
Saudi Arabia
Mountasser Al-Mouqdad Recruiting
Riyadh, Saudi Arabia, 11196
Contact: Mountasser Al-Mouqdad, MD    00966539095090    m.almouqdad@ksmc.med.sa   
Sponsors and Collaborators
King Saud Medical City
Investigators
Principal Investigator: Mountasser Al-Mouqdad, MD King Saud Medical City

Responsible Party: Mountasser Al-Mouqdad, NICU consultant, King Saud Medical City
ClinicalTrials.gov Identifier: NCT03024814     History of Changes
Other Study ID Numbers: HRC-09-Nov15-02
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Fetal Diseases
Infant, Newborn, Diseases
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics