Ductus Arteriosus, PatentPhase 2/3NCT02002741

Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants

A Phase 2/3 study testing Paracetamol in people with Ductus Arteriosus, Patent, run by Rambam Health Care Campus at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants. Read more about this study

Who is it for?: Ages 2 days to 2 months
Conditions the study is for: Ductus Arteriosus, Patent
What is being tested?: Paracetamol
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteIsrael
Study dates: 1 Aug 2014to 31 Dec 2017
Phase: Phase 2/3
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 2 days to 2 months
All sexes
No healthy volunteers
Child

Who may be able to join

Preterm infants born at 24-37 gestational age
diagnosis of Hemodynamically significant patent ductus arteriosus
Medical staff decided to treat with Ibuprofen
Parents have signed informed consent

Who cannot join

Contraindication for ibuprofen
Alanine transaminase /Aspartate transaminase≥ 200 U/L
Significant congenital heart disease

Trial locations and contacts

1 site in 1 country.

Israel1 site

Rambam Medical Center
Haifa, 31096

Other trials in Israel

About this study

Official title: Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants: A Pilot, Double Blind, Randomized, Placebo-control Trial

The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

Read the detailed description

Randomized control trial to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

Conditions: Ductus Arteriosus, Patent
Being tested: Paracetamol, Placebo
Keywords: patent ductus arteriosus, PDA, Preterm, Infant, Electrocardiography, Paracetamol, Acamol, ibuprofen, Placebo
Medical subject headings: Ductus Arteriosus, Patent, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ParacetamolDrug
Also called Acetaminophen, Acamol
Ibuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h
PlaceboDrug
Also called NaCl 0.9%
Ibuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h

Study groups in NCT02002741
Study group	Role	What they receive
Ibuprofen + Paracetamol	Active comparator	Ibuprofen 10mg/kg once --> 5mg/kg twice, q 24h for total of 3 doses + Intravenous Paracetamol : Loading dose 20mg/kg --> 10 mg/kg q6h for total of 12 doses Receives: Drug: Paracetamol
Ibuprofen + Placebo	Placebo comparator	Ibuprofen 10mg/kg once --> 5mg/kg twice, q 24h for total of 3 doses + Placebo (NaCl 0.9%) , Intravenous , at equal volume to the paracetamol in the paracetamol arm, total of 12 doses given q 6h. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The incidence of patent ductus arteriosus closure
By echocardiography
Measured: 3-10 days after first dose of Ibuprofen + study drug

Secondary outcomes (2)

Adverse effects
Renal and liver function, gastrointestinal complications will be assessed from the patient's medical records
Measured: until discharge home (usually within 2-3 months since recruitment)
The need for surgical ligation for PDA
need for surgical ligation for PDA
Measured: 3-21 days after first dose of Ibuprofen + study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201431 Dec 2017

First posted6 Dec 2013 (estimated)
Study start1 Aug 2014
Primary completion31 May 2017
Study completion31 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ductus Arteriosus, PatentStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02002741
Sponsor's protocol ID: IBUACA CTIL
Status last verified: Feb 2020
First submitted: 24 Nov 2013
Last updated: 18 Feb 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Congenital Heart Disease, Congenital Heart Disease (CHD)
Active, not recruiting
PREEMIE: Study for Treatment of PDA in Premature Infants
Patent Ductus Arteriosus (PDA)
Active, not recruitingObservational study
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
Patent Ductus Arteriosus
Active, not recruitingObservational study
PDA for Kidneys Study
Patent Ductus Arteriosus, Congenital Heart Disease
RecruitingPhase 2
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
Patent Ductus Arteriosus After Premature Birth

All Ductus Arteriosus, Patent trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants: A Pilot, Double Blind, Randomized, Placebo-control Trial
ClinicalTrials.gov ID: NCT02002741
Acronym / sponsor ID: IBUACA CTIL
Conditions: Ductus Arteriosus, Patent
Keywords: patent ductus arteriosus, PDA, Preterm, Infant, Electrocardiography, Paracetamol, Acamol, ibuprofen
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Rambam Health Care CampusUniversity, hospital or other
Study start: 1 Aug 2014 (actual)
Primary completion: 31 May 2017 (actual)
Study completion: 31 Dec 2017 (actual)
First posted: 6 Dec 2013 (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 if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

Detailed description

Randomized control trial to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ibuprofen + Paracetamol	Active comparator	Drug: ParacetamolIbuprofen 10mg/kg once --> 5mg/kg twice, q 24h for total of 3 doses + Intravenous Paracetamol : Loading dose 20mg/kg --> 10 mg/kg q6h for total of 12 doses
Ibuprofen + Placebo	Placebo comparator	Drug: PlaceboIbuprofen 10mg/kg once --> 5mg/kg twice, q 24h for total of 3 doses + Placebo (NaCl 0.9%) , Intravenous , at equal volume to the paracetamol in the paracetamol arm, total of 12 doses given q 6h.

Who may qualify

Ages: 2 days to 2 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Preterm infants born at 24-37 gestational age
diagnosis of Hemodynamically significant patent ductus arteriosus
Medical staff decided to treat with Ibuprofen
Parents have signed informed consent

Key exclusion criteria (3 listed)

Contraindication for ibuprofen
Alanine transaminase /Aspartate transaminase≥ 200 U/L
Significant congenital heart disease

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
ParacetamolAlso: Acetaminophen, AcamolIbuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h	Drug	Ibuprofen + Paracetamol
PlaceboAlso: NaCl 0.9%Ibuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h	Drug	Ibuprofen + Placebo

Primary outcome

The incidence of patent ductus arteriosus closure
Time frame: 3-10 days after first dose of Ibuprofen + study drug
By echocardiography

2 secondary outcomes

Adverse effects
Time frame: until discharge home (usually within 2-3 months since recruitment)
The need for surgical ligation for PDA
Time frame: 3-21 days after first dose of Ibuprofen + study drug

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
Individual participant dataSharing planned: No

Related trials for Ductus Arteriosus, Patent

Recruiting
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Congenital Heart Disease, Congenital Heart Disease (CHD)
Active, not recruiting
PREEMIE: Study for Treatment of PDA in Premature Infants
Patent Ductus Arteriosus (PDA)
Active, not recruitingObservational study
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
Patent Ductus Arteriosus
Active, not recruitingObservational study
PDA for Kidneys Study
Patent Ductus Arteriosus, Congenital Heart Disease
RecruitingPhase 2
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
Patent Ductus Arteriosus After 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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Paracetamol in people with Ductus Arteriosus, Patent, run by Rambam Health Care Campus at 1 site in Israel.

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 4 inclusion and 3 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: finished, as of the sponsor's last update on 18 Feb 2020. 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 Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of patent ductus arteriosus closure (time frame: 3-10 days after first dose of Ibuprofen + study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02002741.

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 18 Feb 2020.