Intraventricular Haemorrhage NeonatalPhase 3NCT03024814
Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants
A Phase 3 study testing Acetaminophen and Dextrose 5 in people with Intraventricular Haemorrhage Neonatal, run by King Saud Medical City at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 1 hour to 6 months
- Conditions the study is for
- Intraventricular Haemorrhage Neonatal
- What is being tested?
- Acetaminophen and Dextrose 5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Oct 2016to Oct 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature baby less than or equal 32 week and birth weight less than or equal 1500 g
Who cannot join
- Out-born babies, infants with major congenital anomalies, babies have IVH III, IV, High expectancy of early death
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Mountasser Al-Mouqdad
Riyadh, 11196
Mountasser Al-Mouqdad, MD, 00966539095090, m.almouqdad@ksmc.med.sa
About this study
The purpose of this study is to determine whether acetaminophen is effective in prevention or reducing the severity of IVH in premature infants.
Read the 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
- Being tested
- Acetaminophen, Dextrose 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Paracetamol
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 5Drug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| acetaminophen group | Experimental | Babies who took acetaminophen Receives: Drug: Acetaminophen |
| Placebo group (Dextrose 5) | Experimental | Babies who took placebo Receives: Drug: Dextrose 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of intraventricular hemorrhage (IVH will be graded by Papile score) among the infants on acetaminophen compared to the infants on placebo.
Measured: within the first week of age
Secondary outcomes (3)
The incidence of neonatal sepsis in the premature babies who received acetaminophen
Measured: 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
Measured: 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
Measured: Corrected 40 weeks of gestational age or time of discharge will be used
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraventricular Haemorrhage NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud Medical City
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mountasser Al-Mouqdad, King Saud Medical City
- Investigators
- Mountasser Al-Mouqdad, MD, Principal investigator, King Saud Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024814
- Sponsor's protocol ID
- HRC-09-Nov15-02
- Status last verified
- Jan 2017
- First submitted
- 14 Nov 2016
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants
- ClinicalTrials.gov ID
- NCT03024814
- Acronym / sponsor ID
- HRC-09-Nov15-02
- Conditions
- Intraventricular Haemorrhage Neonatal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- King Saud Medical CityOther government
- Study start
- Oct 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acetaminophen group | Experimental | Drug: AcetaminophenBabies who took acetaminophen |
| Placebo group (Dextrose 5) | Experimental | Drug: Dextrose 5Babies who took placebo |
Who may qualify
- Ages
- 1 hour to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Premature baby less than or equal 32 week and birth weight less than or equal 1500 g
Key exclusion criteria (1 listed)
- Out-born babies, infants with major congenital anomalies, babies have IVH III, IV, High expectancy of early death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenAlso: ParacetamolThe 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. | Drug | acetaminophen group |
| Dextrose 5Also: 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. | Drug | Placebo group (Dextrose 5) |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Intraventricular Haemorrhage Neonatal
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
Enrolling by invitationObservational study
Intelligent Physiological Monitoring to Predict Preterm Brain Injury
Cerebral Palsy (CP), Intraventricular Hemorrhage Neonatal
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruiting
Intranasal Fresh Mother's Own Milk to Prevent Intraventricular Hemorrhage in Extremely Preterm Infants
Intraventricular Hemorrhage, Premature Birth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mountasser Al-Mouqdad, MD principal investigator
King Saud Medical City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetaminophen and Dextrose 5 in people with Intraventricular Haemorrhage Neonatal, run by King Saud Medical City at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mountasser Al-Mouqdafd, MD (00966539095090, m.almouqdad@ksmc.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.