Patent Ductus ArteriosusPhase 4NCT01536158
Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial
A Phase 4 study testing Oral paracetamol and Oral ibuprofen in people with Patent Ductus Arteriosus, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants. Read more about this study
- Who is it for?
- Ages 2 to 10 days
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- Oral paracetamol and Oral ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2012to Dec 2012
- Phase
- Phase 4
- 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 to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight below 1250 gram
- Diagnosed patent ductus arteriosus by Echocardiographic examination
Who cannot join
- Accompanied other congenital cardiac anomalies
- Urine output of less than 1 ml/kg/h during the preceding 8 h,
- Serum creatinine level >1.6 mg/dl,
- Platelet count <60,000/mm3,
- Liver failure,
- Hyperbilirubinemia requiring exchange transfusion
- Severe intracranial bleeding (Grade III - IV)
- Intestinal abnormality and necrotising enterocolitis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
Ankara, 06110
About this study
Official title: Oral Paracetamol Versus Oral Ibuprofen Treatment
The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.
Read the detailed description
To determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.
Eighty preterm infants with patent ductus arteriosus will be enrolled in this prospective-randomized study. Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h or oral paracetamol 15 mg/kg per dose every 6 hours.
One of the following echocardiographic criteria of a duct size >1.5 mm, a left atrium-to-aorta ratio >1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of treatment.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- Oral paracetamol, Oral ibuprofen
- Keywords
- Patent Ductus Arteriosus, Paracetamol, Ibuprofen, Preterm infant
- 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.
Oral paracetamolDrug
Also called Calpol
Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.
Oral ibuprofenDrug
Also called Pedifen
Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
| Study group | Role | What they receive |
|---|---|---|
| Oral paracetamol | Active comparator | Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours. Receives: Drug: Oral paracetamol |
| Oral ibuprofen | Active comparator | Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h. Receives: Drug: Oral ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen
To compare the closure rate of patent ductus arteriosus after oral paracetamol or oral ibuprofen treatment
Measured: Until discharge
Secondary outcomes (1)
Long term effects of oral paracetamol versus oral ibuprofen treatment in preterm infants
Long term effects such as ROP, BPD,IVH, duration of respiratory support and hospitalization are going to be evaluated.
Measured: corrected 36 weeks or until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patent Ductus ArteriosusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- Mehmet Yekta Oncel, MD, Principal investigator, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536158
- Sponsor's protocol ID
- ZTB150212
- Status last verified
- Dec 2012
- First submitted
- 15 Feb 2012
- Last updated
- 27 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jasani B, Mitra S, Shah PS. Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants. Cochrane Database Syst Rev. 2022 Dec 15;12(12):CD010061. doi: 10.1002/14651858.CD010061.pub5.
PubMed 36519620Oncel MY, Eras Z, Uras N, Canpolat FE, Erdeve O, Oguz SS. Neurodevelopmental Outcomes of Preterm Infants Treated with Oral Paracetamol Versus Ibuprofen for Patent Ductus Arteriosus. Am J Perinatol. 2017 Oct;34(12):1185-1189. doi: 10.1055/s-0037-1601564. Epub 2017 Apr 10.
PubMed 28395364Oncel MY, Yurttutan S, Erdeve O, Uras N, Altug N, Oguz SS, Canpolat FE, Dilmen U. Oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosus in preterm infants: a randomized controlled trial. J Pediatr. 2014 Mar;164(3):510-4.e1. doi: 10.1016/j.jpeds.2013.11.008. Epub 2013 Dec 18.
PubMed 24359938
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Paracetamol Versus Oral Ibuprofen Treatment
- ClinicalTrials.gov ID
- NCT01536158
- Acronym / sponsor ID
- ZTB150212
- Conditions
- Patent Ductus Arteriosus
- Keywords
- Patent Ductus Arteriosus, Paracetamol, Ibuprofen, Preterm infant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Feb 2012 (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 oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.
Detailed description
To determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.
Eighty preterm infants with patent ductus arteriosus will be enrolled in this prospective-randomized study. Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h or oral paracetamol 15 mg/kg per dose every 6 hours.
One of the following echocardiographic criteria of a duct size >1.5 mm, a left atrium-to-aorta ratio >1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral paracetamol | Active comparator | Drug: Oral paracetamolPatients will receive oral paracetamol 15 mg/kg per dose every 6 hours. |
| Oral ibuprofen | Active comparator | Drug: Oral ibuprofenPatients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h. |
Who may qualify
- Ages
- 2 to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Birth weight below 1250 gram
- Diagnosed patent ductus arteriosus by Echocardiographic examination
Key exclusion criteria (8 listed)
- Accompanied other congenital cardiac anomalies
- Urine output of less than 1 ml/kg/h during the preceding 8 h,
- Serum creatinine level >1.6 mg/dl,
- Platelet count <60,000/mm3,
- Liver failure,
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 |
|---|---|---|
| Oral paracetamolAlso: CalpolPatients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days. | Drug | Oral paracetamol |
| Oral ibuprofenAlso: PedifenPatients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h. | Drug | Oral ibuprofen |
Primary outcome
Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen
Time frame: Until discharge
To compare the closure rate of patent ductus arteriosus after oral paracetamol or oral ibuprofen treatment
1 secondary outcome
Long term effects of oral paracetamol versus oral ibuprofen treatment in preterm infants
Time frame: corrected 36 weeks or until discharge
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 27 Dec 2012.
- Derived from this study: PubMed 36519620Jasani B, Mitra S, Shah PS. Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants. Cochrane Database Syst Rev. 2022 Dec 15;12(12):CD010061. doi: 10.1002/14651858.CD010061.pub5.
- Derived from this study: PubMed 28395364Oncel MY, Eras Z, Uras N, Canpolat FE, Erdeve O, Oguz SS. Neurodevelopmental Outcomes of Preterm Infants Treated with Oral Paracetamol Versus Ibuprofen for Patent Ductus Arteriosus. Am J Perinatol. 2017 Oct;34(12):1185-1189. doi: 10.1055/s-0037-1601564. Epub 2017 Apr 10.
- Derived from this study: PubMed 24359938Oncel MY, Yurttutan S, Erdeve O, Uras N, Altug N, Oguz SS, Canpolat FE, Dilmen U. Oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosus in preterm infants: a randomized controlled trial. J Pediatr. 2014 Mar;164(3):510-4.e1. doi: 10.1016/j.jpeds.2013.11.008. Epub 2013 Dec 18.
- IbuprofenLink provided by the sponsor.
- ParacetamolLink provided by the sponsor.
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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.
Mehmet Yekta Oncel, MD principal investigator
Zekai Tahir Burak Women's Health Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral paracetamol and Oral ibuprofen in people with Patent Ductus Arteriosus, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 8 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 27 Dec 2012. 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 Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen (time frame: Until discharge). 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 NCT01536158, which also lists 3 linked publications.
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 27 Dec 2012.