Patent Ductus Arteriosus in Preterm InfantsNCT06601114
The Effectiveness of Paracetamol Versus Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Neonates
A study testing Paracetamol Group and Ibuprofen group in people with Patent Ductus Arteriosus in Preterm Infants, run by Arooj Khan at 1 site in Pakistan.
Trial summary
This study aims to find and compare the effectiveness of paracetamol and ibuprofen in the closure of patent ductus arteriosus in preterm neonates. The study is being conducted at Department of Nursery (special care baby unit) and Neonatal intensive care unit (NICU), KTH, Peshawar. Read more about this study
- Who is it for?
- Ages 48 to 96 hours
- Conditions the study is for
- Patent Ductus Arteriosus in Preterm Infants
- What is being tested?
- Paracetamol Group and Ibuprofen group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Apr 2024to 10 Oct 2024
- Phase
- Interventional
- 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 48 to 96 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates of gestational age more than 30 weeks and less than 37 weeks
- Neonates with birthweight of ≥1250g
- Neonates with postnatal age of 48-96 hours
- Neonates having one of the following echocardiographic criteria: a duct size \> 2mm, a left atrium-to-aorta ratio \>1.4, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition to clinical signs of patent ductus arteriosus
Who cannot join
- Gestational age less than 30 weeks and more than 37 weeks
- Presence of major congenital abnormalities
- Right-to-left ductal shunting
- Life-threatening infection
- Grade III or grade IV intraventricular hemorrhage
- Platelet count of \<60000/mm3
- Hyperbilirubinemia requiring blood transfusion
- Persistent pulmonary hypertension
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
MTI, Khyber Teaching Hospital
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
This study aims to find and compare the effectiveness of paracetamol and ibuprofen in the closure of patent ductus arteriosus in preterm neonates.
The study is being conducted at Department of Nursery (special care baby unit) and Neonatal intensive care unit (NICU), KTH, Peshawar.
Neonates diagnosed with patent ductus arteriosus (PDA) in the Special care baby unit (SCBU) and Neonatal Intensive Care Unit (NICU) were enrolled in the study after obtaining ethical approval and informed consent from caretakers. The babies received routine care according to departmental policies. For PDA management, participants were randomly assigned to Group A, receiving oral paracetamol (Panadol, 15 mg/kg every 6 hours for 3 days), or Group B, receiving oral ibuprofen (Brufen, 10 mg/kg followed by 5 mg/kg after 24 and 48 hours). Paracetamol was defined as a selective COX-2 inhibitor, while ibuprofen was a non-selective COX inhibitor, both working by inhibiting prostaglandin synthesis. Procedures were supervised by a consultant pediatrician, with continuous patient monitoring. Treatment effectiveness, defined as complete PDA closure on echocardiography, was assessed at the end of the study.
- Being tested
- Paracetamol Group, Ibuprofen group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol GroupDrug
Also called Experimental: Group B: Ibuprofen Group
Group A: Paracetamol Group will receive Oral form of paracetamol with dosage of 15mg/kg every 6 hours for 3 days
Ibuprofen groupDrug
Group B: Ibuprofen Group will receive oral form of ibuprofen at initial dosage of 10mg/kg followed by 5mg/kg after 24 hours and 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Paracetamol Group | Active comparator | Group A: Paracetamol Group will receive Oral form of paracetamol with dosage of 15mg/kg every 6 hours for 3 days Receives: Drug: Paracetamol Group |
| Group B: Ibuprofen Group | Experimental | Group B: Ibuprofen Group will receive oral form of ibuprofen at initial dosage of 10mg/kg followed by 5mg/kg after 24 hours and 48 hours. Receives: Drug: Ibuprofen group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of Patent Ductus Arteriosus
The primary outcome is defined as the number of participants who achieve complete closure of the patent ductus arteriosus (PDA) after a course of the drug, as confirmed by echocardiography. Complete closure will be determined by the absence of ductal flow on color Doppler echocardiography
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Apr 2024
- Primary completion10 Oct 2024 (estimated)
- Study completion10 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patent Ductus Arteriosus in Preterm InfantsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arooj Khan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arooj Khan, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601114
- Sponsor's protocol ID
- 797/DME/KMC
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ohlsson A, Shah PS. Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low-birth-weight infants. Cochrane Database Syst Rev. 2015 Mar 11;(3):CD010061. doi: 10.1002/14651858.CD010061.pub2.
PubMed 25758061Slaughter JL, Reagan PB, Newman TB, Klebanoff MA. Comparative Effectiveness of Nonsteroidal Anti-inflammatory Drug Treatment vs No Treatment for Patent Ductus Arteriosus in Preterm Infants. JAMA Pediatr. 2017 Mar 6;171(3):e164354. doi: 10.1001/jamapediatrics.2016.4354. Epub 2017 Mar 6.
PubMed 28046188Al-Lawama M, Alammori I, Abdelghani T, Badran E. Oral paracetamol versus oral ibuprofen for treatment of patent ductus arteriosus. J Int Med Res. 2018 Feb;46(2):811-818. doi: 10.1177/0300060517722698. Epub 2017 Sep 14.
PubMed 29239259Shah SMA, Khan SA, Sadiq F, Gul R, Sadiq F, Khan MU, Khan MK, Uzma F, Khan A, Khan S. Comparison of the Effectiveness of Paracetamol and Ibuprofen in the Management of Patent Ductus Arteriosus in Preterm Neonates: A Randomized Controlled Trial. Mol Cell Pediatr. 2025 Jan 25;12(1):2. doi: 10.1186/s40348-025-00189-x.
PubMed 39862321
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Paracetamol Versus Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Neonates
- ClinicalTrials.gov ID
- NCT06601114
- Acronym / sponsor ID
- 797/DME/KMC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Arooj KhanUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 10 Oct 2024 (estimated)
- First posted
- 19 Sep 2024 (actual)
- 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.
This study aims to find and compare the effectiveness of paracetamol and ibuprofen in the closure of patent ductus arteriosus in preterm neonates.
The study is being conducted at Department of Nursery (special care baby unit) and Neonatal intensive care unit (NICU), KTH, Peshawar.
Neonates diagnosed with patent ductus arteriosus (PDA) in the Special care baby unit (SCBU) and Neonatal Intensive Care Unit (NICU) were enrolled in the study after obtaining ethical approval and informed consent from caretakers. The babies received routine care according to departmental policies. For PDA management, participants were randomly assigned to Group A, receiving oral paracetamol (Panadol, 15 mg/kg every 6 hours for 3 days), or Group B, receiving oral ibuprofen (Brufen, 10 mg/kg followed by 5 mg/kg after 24 and 48 hours). Paracetamol was defined as a selective COX-2 inhibitor, while ibuprofen was a non-selective COX inhibitor, both working by inhibiting prostaglandin synthesis. Procedures were supervised by a consultant pediatrician, with continuous patient monitoring. Treatment effectiveness, defined as complete PDA closure on echocardiography, was assessed at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Paracetamol Group | Active comparator | Drug: Paracetamol GroupGroup A: Paracetamol Group will receive Oral form of paracetamol with dosage of 15mg/kg every 6 hours for 3 days |
| Group B: Ibuprofen Group | Experimental | Drug: Ibuprofen groupGroup B: Ibuprofen Group will receive oral form of ibuprofen at initial dosage of 10mg/kg followed by 5mg/kg after 24 hours and 48 hours. |
Who may qualify
- Ages
- 48 to 96 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Neonates of gestational age more than 30 weeks and less than 37 weeks
- Neonates with birthweight of ≥1250g
- Neonates with postnatal age of 48-96 hours
- Neonates having one of the following echocardiographic criteria: a duct size \> 2mm, a left atrium-to-aorta ratio \>1.4, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition to clinical signs of patent ductus arteriosus
Key exclusion criteria (8 listed)
- Gestational age less than 30 weeks and more than 37 weeks
- Presence of major congenital abnormalities
- Right-to-left ductal shunting
- Life-threatening infection
- Grade III or grade IV intraventricular hemorrhage
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 |
|---|---|---|
| Paracetamol GroupAlso: Experimental: Group B: Ibuprofen GroupGroup A: Paracetamol Group will receive Oral form of paracetamol with dosage of 15mg/kg every 6 hours for 3 days | Drug | Group A: Paracetamol Group |
| Ibuprofen groupGroup B: Ibuprofen Group will receive oral form of ibuprofen at initial dosage of 10mg/kg followed by 5mg/kg after 24 hours and 48 hours. | Drug | Group B: Ibuprofen Group |
Primary outcome
Closure of Patent Ductus Arteriosus
Time frame: 3 days
The primary outcome is defined as the number of participants who achieve complete closure of the patent ductus arteriosus (PDA) after a course of the drug, as confirmed by echocardiography. Complete closure will be determined by the absence of ductal flow on color Doppler echocardiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 25758061Ohlsson A, Shah PS. Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low-birth-weight infants. Cochrane Database Syst Rev. 2015 Mar 11;(3):CD010061. doi: 10.1002/14651858.CD010061.pub2.
- Background: PubMed 28046188Slaughter JL, Reagan PB, Newman TB, Klebanoff MA. Comparative Effectiveness of Nonsteroidal Anti-inflammatory Drug Treatment vs No Treatment for Patent Ductus Arteriosus in Preterm Infants. JAMA Pediatr. 2017 Mar 6;171(3):e164354. doi: 10.1001/jamapediatrics.2016.4354. Epub 2017 Mar 6.
- Background: PubMed 29239259Al-Lawama M, Alammori I, Abdelghani T, Badran E. Oral paracetamol versus oral ibuprofen for treatment of patent ductus arteriosus. J Int Med Res. 2018 Feb;46(2):811-818. doi: 10.1177/0300060517722698. Epub 2017 Sep 14.
- Derived from this study: PubMed 39862321Shah SMA, Khan SA, Sadiq F, Gul R, Sadiq F, Khan MU, Khan MK, Uzma F, Khan A, Khan S. Comparison of the Effectiveness of Paracetamol and Ibuprofen in the Management of Patent Ductus Arteriosus in Preterm Neonates: A Randomized Controlled Trial. Mol Cell Pediatr. 2025 Jan 25;12(1):2. doi: 10.1186/s40348-025-00189-x.
- Individual participant dataSharing planned: No
Related trials for Patent Ductus Arteriosus in Preterm Infants
Active, not recruiting
PREEMIE: Study for Treatment of PDA in Premature Infants
Patent Ductus Arteriosus (PDA)
RecruitingPhase 2
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
Patent Ductus Arteriosus After Premature Birth
Not yet recruiting
Radiological Markers for PDA Management in Preterm Infants
Patent Ductus Arteriosus in Preterm Infants
Active, not recruitingPhase 3
Management of the PDA Trial
Infant, Premature, Patent Ductus Arteriosus
RecruitingObservational study
NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot
Preterm, Patent Ductus Arteriosus
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 study testing Paracetamol Group and Ibuprofen group in people with Patent Ductus Arteriosus in Preterm Infants, run by Arooj Khan at 1 site in Pakistan.
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 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Pakistan. 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.
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?
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?
Closure of Patent Ductus Arteriosus (time frame: 3 days). 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 NCT06601114, which also lists 4 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 19 Sep 2024.