Patent Ductus ArteriosusPhase 1/2NCT06256211
Assessment of Therapeutic Effect of Rectal Vs. Intravenous Paracetamol in The Treatment of Patent Ductus Arteriosus (PDA) in Neonates
A Phase 1/2 study testing Paracetamol in people with Patent Ductus Arteriosus, run by Soha mahmoud Hussien mahdy.
Trial summary
To compare the effectiveness of rectal vs. intravenous paracetamol in the medical treatment of significant PDA in neonates. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- Paracetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 30 Dec 2024
- Phase
- Phase 1/2
- 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 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All the neonates with hemodynamic significance PDA10,13 that is indicated for closure.
Who cannot join
- Neonates with the following criteria are excluded.
- Without PDA.
- With insignificant PDA.
- Rectosigmoid abnormalities.
- Neutropenia less than 1500 cells/ml.
- Platelets less than 30000 cells/ml.
Show all 9Show fewer
- Liver failure or elevated liver enzymes.
- Hypovolemic or septic shock.
- Renal failure.
Trial locations and contacts
No sites are listed yet.
About this study
To compare the effectiveness of rectal vs. intravenous paracetamol in the medical treatment of significant PDA in neonates.
Read the detailed description
The ductus arteriosus (DA) is a vascular channel between the aorta and the pulmonary artery (PA). It diverts blood away from the lungs and directs it to systemic circulation during pregnancy.1 Therefore, its opening is necessary for the life of the fetus, but after birthing its closure is necessary. During pregnancy, the DA and the placenta produce vasodilators that keep the DA open, but, in term infants, as they are born, the number of contractile factors increases, the sensitivity of DA to prostaglandins decreases, and sensitivity to oxygen increases which causes ductal constriction. In contrast, in premature infants, DA sensitivity to vasodilators increases, although this sensitivity decreases with increasing neonatal age. Patent ductus arteriosus (PDA) is a major life-threatening problem in premature and low birth weight infants. In 60% to 70% of preterm and low birth weight infants, the DA remains open.
The choice of treatment depends on factors like PDA size, patient age, health status, and symptomatology. The types of treatment for Patent Ductus Arteriosus (PDA) include medical treatment involving medications to encourage closure, catheter-based intervention using minimally invasive procedures to block the ductus arteriosus, and surgical closure through a small chest incision.
Regarding the medical treatment, non-specific cyclooxygenase (COX) inhibitors (indomethacin, ibuprofen). These drugs work by inhibiting cyclooxygenase and stopping the synthesis of prostaglandins E2, F2a, I2, and thromboxane A2. This is followed by vascular smooth muscle constriction, local ischemia, angiogenesis, DA intima regeneration, wall fibrosis, and DA closure. Ibuprofen and indomethacin are standard treatments for PDA closure, but due to possible side effects in the gastrointestinal tract, kidney, chronic lung disease, thrombocytopenia, and hyperbilirubinemia, it is preferable to use acetaminophen/paracetamol with fewer side effects.
In addition, PDA closure may be associated with complications such as chronic lung disease, heart disease, neurodevelopmental disorder, and retinopathy of prematurity (ROP).1 Therefore, it is desirable to prescribe drugs with no contraindications and fewer side effects to close PDA. The effect of acetaminophen/paracetamol on PDA closure was first reported in 2011,6 and extensive studies on its effects have been performed since then.6,7,8 Due to its properties such as safety, availability, low price, lack of side effects related to nonsteroidal anti-inflammatory drugs (NSAIDs), and the fact that this drug has been used as an anti-inflammatory and analgesic treatment in infants for many years, acetaminophen will gradually replace NSAIDs for PDA medical closure.
Surgery for PDA closure is performed when treatment with COX inhibitors is contraindicated or unsuccessful.
Rectal administration of paracetamol involves inserting a suppository into the rectum for absorption into the bloodstream, offering the advantages of being less invasive and suitable for limited vascular access, while potentially causing slower and variable absorption; intravenous (IV) paracetamol, delivered directly into the bloodstream through a vein, ensures accurate dosing, rapid absorption, and consistent drug delivery, but requires established intravenous access and vigilant monitoring for potential adverse effects, with both methods having potential systemic side effects and varying efficacy in promoting PDA closure.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- Paracetamol
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
All cases will be randomized simply by opaque closed envelop and treated with either rectal or intravenous paracetamol according to the following doses.
- Rectal dose
- Rectal paracetamol at a dose of 25 mg/kg body weight with started and then continued at a dose of 15 mg/kg body weight every 8 hours for 3 days (ten doses in total) in neonates weighing more than 1000 gm.11
- The patient's weight is less than 1000 gm, the initial dose was 15 mg/kg body weight, and the suspense doses are 7.5 mg/kg body weight every 8 hours for 3 days (10 doses in total).11
- Intravenous dose
- Intravenous paracetamol dose 15 mg/kg body weight every 6 hours for 3 days (12 doses in total).12
- After the 3-day follow up echocardiogram will be done.12 This will be the end of randomization for the purpose of the study.
| Study group | Role | What they receive |
|---|---|---|
| Group has treated by Intravenous Paracetamol | Other | * Intravenous paracetamol dose 15 mg/kg body weight every 6 hours for 3 days (12 doses in total).
* After the 3-day follow up echocardiogram will be done. Receives: Drug: Paracetamol |
| Group has treated by Rectal Paracetamol | Other | * Rectal paracetamol at a dose of 25 mg/kg body weight with started and then continued at a dose of 15 mg/kg body weight every 8 hours for 3 days (ten doses in total) in neonates weighing more than 1000 gm.
* The patient's weight is less than 1000 gm, the initial dose was 15 mg/kg body weight, and the suspense doses are 7.5 mg/kg body weight every 8 hours for 3 days (10 doses in total). Receives: Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment the rate of efficiency of Rectal and Intravenous Paracetamol in The Treatment of Patent Ductus Arteriosus (PDA) in Neonates
using clinical by decrease signs and symptoms caused by PDA and using echocardiography to detect decreasing size pf PDA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Neonates with PDA
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soha mahmoud Hussien mahdy
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Soha mahmoud Hussien mahdy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256211
- Sponsor's protocol ID
- Patent Ductus Arteriosus
- Status last verified
- Feb 2024
- First submitted
- 10 Nov 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sivanandan S, Agarwal R. Pharmacological Closure of Patent Ductus Arteriosus: Selecting the Agent and Route of Administration. Paediatr Drugs. 2016 Apr;18(2):123-38. doi: 10.1007/s40272-016-0165-5.
PubMed 26951240Chiruvolu A, Jaleel MA. Therapeutic management of patent ductus arteriosus. Early Hum Dev. 2009 Mar;85(3):151-5. doi: 10.1016/j.earlhumdev.2008.12.007. Epub 2009 Feb 14.
PubMed 19217726
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Therapeutic Effect of Rectal Vs. Intravenous Paracetamol in The Treatment of Patent Ductus Arteriosus (PDA) in Neonates
- ClinicalTrials.gov ID
- NCT06256211
- Acronym / sponsor ID
- Patent Ductus Arteriosus
- Conditions
- Patent Ductus Arteriosus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Soha mahmoud Hussien mahdyUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Feb 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.
To compare the effectiveness of rectal vs. intravenous paracetamol in the medical treatment of significant PDA in neonates.
Detailed description
The ductus arteriosus (DA) is a vascular channel between the aorta and the pulmonary artery (PA). It diverts blood away from the lungs and directs it to systemic circulation during pregnancy.1 Therefore, its opening is necessary for the life of the fetus, but after birthing its closure is necessary. During pregnancy, the DA and the placenta produce vasodilators that keep the DA open, but, in term infants, as they are born, the number of contractile factors increases, the sensitivity of DA to prostaglandins decreases, and sensitivity to oxygen increases which causes ductal constriction. In contrast, in premature infants, DA sensitivity to vasodilators increases, although this sensitivity decreases with increasing neonatal age. Patent ductus arteriosus (PDA) is a major life-threatening problem in premature and low birth weight infants. In 60% to 70% of preterm and low birth weight infants, the DA remains open.
The choice of treatment depends on factors like PDA size, patient age, health status, and symptomatology. The types of treatment for Patent Ductus Arteriosus (PDA) include medical treatment involving medications to encourage closure, catheter-based intervention using minimally invasive procedures to block the ductus arteriosus, and surgical closure through a small chest incision.
Regarding the medical treatment, non-specific cyclooxygenase (COX) inhibitors (indomethacin, ibuprofen). These drugs work by inhibiting cyclooxygenase and stopping the synthesis of prostaglandins E2, F2a, I2, and thromboxane A2. This is followed by vascular smooth muscle constriction, local ischemia, angiogenesis, DA intima regeneration, wall fibrosis, and DA closure. Ibuprofen and indomethacin are standard treatments for PDA closure, but due to possible side effects in the gastrointestinal tract, kidney, chronic lung disease, thrombocytopenia, and hyperbilirubinemia, it is preferable to use acetaminophen/paracetamol with fewer side effects.
In addition, PDA closure may be associated with complications such as chronic lung disease, heart disease, neurodevelopmental disorder, and retinopathy of prematurity (ROP).1 Therefore, it is desirable to prescribe drugs with no contraindications and fewer side effects to close PDA. The effect of acetaminophen/paracetamol on PDA closure was first reported in 2011,6 and extensive studies on its effects have been performed since then.6,7,8 Due to its properties such as safety, availability, low price, lack of side effects related to nonsteroidal anti-inflammatory drugs (NSAIDs), and the fact that this drug has been used as an anti-inflammatory and analgesic treatment in infants for many years, acetaminophen will gradually replace NSAIDs for PDA medical closure.
Surgery for PDA closure is performed when treatment with COX inhibitors is contraindicated or unsuccessful.
Rectal administration of paracetamol involves inserting a suppository into the rectum for absorption into the bloodstream, offering the advantages of being less invasive and suitable for limited vascular access, while potentially causing slower and variable absorption; intravenous (IV) paracetamol, delivered directly into the bloodstream through a vein, ensures accurate dosing, rapid absorption, and consistent drug delivery, but requires established intravenous access and vigilant monitoring for potential adverse effects, with both methods having potential systemic side effects and varying efficacy in promoting PDA closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Neonates with PDA
| Arm | Type | Receives |
|---|---|---|
| Group has treated by Intravenous Paracetamol | Other | Drug: Paracetamol* Intravenous paracetamol dose 15 mg/kg body weight every 6 hours for 3 days (12 doses in total). * After the 3-day follow up echocardiogram will be done. |
| Group has treated by Rectal Paracetamol | Other | Drug: Paracetamol* Rectal paracetamol at a dose of 25 mg/kg body weight with started and then continued at a dose of 15 mg/kg body weight every 8 hours for 3 days (ten doses in total) in neonates weighing more than 1000 gm. * The patient's weight is less than 1000 gm, the initial dose was 15 mg/kg body weight, and the suspense doses are 7.5 mg/kg body weight every 8 hours for 3 days (10 doses in total). |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All the neonates with hemodynamic significance PDA10,13 that is indicated for closure.
Key exclusion criteria (9 listed)
- Neonates with the following criteria are excluded.
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 |
|---|---|---|
| ParacetamolAll cases will be randomized simply by opaque closed envelop and treated with either rectal or intravenous paracetamol according to the following doses. * Rectal dose * Rectal paracetamol at a dose of 25 mg/kg body weight with started and then continued at a dose of 15 mg/kg body weight every 8 hours for 3 days (ten doses in total) in neonates weighing more than 1000 gm.11 * The patient's weight is less than 1000 gm, the initial dose was 15 mg/kg body weight, and the suspense doses are 7.5 mg/kg body weight every 8 hours for 3 days (10 doses in total).11 * Intravenous dose * Intravenous paracetamol dose 15 mg/kg body weight every 6 hours for 3 days (12 doses in total).12 * After the 3-day follow up echocardiogram will be done.12 This will be the end of randomization for the purpose of the study. | Drug | Group has treated by Intravenous Paracetamol, Group has treated by Rectal Paracetamol |
Primary outcome
Assessment the rate of efficiency of Rectal and Intravenous Paracetamol in The Treatment of Patent Ductus Arteriosus (PDA) in Neonates
Time frame: 1 year
using clinical by decrease signs and symptoms caused by PDA and using echocardiography to detect decreasing size pf PDA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Results publication: PubMed 26951240Sivanandan S, Agarwal R. Pharmacological Closure of Patent Ductus Arteriosus: Selecting the Agent and Route of Administration. Paediatr Drugs. 2016 Apr;18(2):123-38. doi: 10.1007/s40272-016-0165-5.
- Results publication: PubMed 19217726Chiruvolu A, Jaleel MA. Therapeutic management of patent ductus arteriosus. Early Hum Dev. 2009 Mar;85(3):151-5. doi: 10.1016/j.earlhumdev.2008.12.007. Epub 2009 Feb 14.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Paracetamol in people with Patent Ductus Arteriosus, run by Soha mahmoud Hussien mahdy.
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 9 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Soha Ma Hussein, Msc. student (+2001061554768, sohamahdy25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment the rate of efficiency of Rectal and Intravenous Paracetamol in The Treatment of Patent Ductus Arteriosus (PDA) in Neonates (time frame: 1 year). 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 NCT06256211, which also lists 2 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 13 Feb 2024.