Neonatal PrematurityNCT07338370
Relation Between Prostaglandin E2 Metabolite Levels and the Development of Hemodynamically Significant Patent Ductus Arteriosus in Preterm Neonates
An observational study of Neonatal Prematurity and Patent Ductus Arteriosus in Preterm Infants, run by Ain Shams University at 1 site in Egypt.
Trial summary
prospective observational cohort study to explore the relationship between PGE2 metabolite levels and the development of hemodynamically significant PDA in preterm neonates. Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Neonatal Prematurity, Patent Ductus Arteriosus in Preterm Infants, Prostaglandins
- What is being tested?
- Ibuprofen (Brufen®)
- Type of treatment
- Pill or oral medicine
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2026to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 7 days
- All sexes
- No healthy volunteers
- Child
Study population: Preterm neonates admitted to Ain shams University Hospital NICUs fulfilling the inclusion criteria
Who may be able to join
- Preterm neonates with gestational age ≤ 32 weeks, admitted to the NICU and diagnosed with patent ductus arteriosus by echocardiography on day 3 of life.
Who cannot join
- Preterm neonates with evidence of any of the following will be excluded:
- Chromosomal anomaly or Congenital malformations Progressive intraventricular hemorrhage Congenital heart defect other than PDA and/or patent foramen ovale Pulmonary hypertension with right to left shunt on PDA Contraindications to the use of Ibuprofen: [1] Urine output <1 mL/kg/hour during preceding 8 hours. Serum creatinine >1.6 mg/dL. Platelet count <50 000/mm3. Abnormal coagulation profile. Necrotizing enterocolitis (NEC) or intestinal perforation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sondos Ahmed contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Ain Shams, University
Cairo, Abbasia, 11517
mennatallah Ayman, master, 01004137614, menahayman@gmail.com
About this study
prospective observational cohort study to explore the relationship between PGE2 metabolite levels and the development of hemodynamically significant PDA in preterm neonates.
Read the detailed description
Regulation of ductus arteriosus involves (PGE2), produced by the placenta and DA itself, that promotes ductal patency by relaxing smooth muscle.
Prostaglandins are pluripotent lipid mediators derived from membrane glycerophospholipid metabolism. They are synthesized via a multienzyme cascade involving the actions of phospholipases and COX isoforms. Prostanoids, such as prostaglandin E2 and prostaglandin D2 metabolite (PGDM), are produced by various structural and inflammatory cells.
Cyclooxygenase inhibitors restrict the PDA by inhibiting the prostaglandin synthase enzyme, which prevents arachidonic acid from converting to prostaglandin. Acetaminophen is also believed to inhibit the prostaglandin synthesis enzyme's peroxidase portion, resulting in the PDA narrowing.
A significant decrease in serum PGE2 levels was observed following COX inhibitor treatment.
- Being tested
- Ibuprofen (Brufen®)
- Keywords
- cerebral blood flow, neonates, PDA, preterms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen (Brufen®)Drug
Group1will receive anti-PGE; Ibuprofen (IBU) (brufen)® syrup will be given for 3 days enterally either orally or via a gastric tube with an initial dose of 10mg/kg/day, followed by 5mg/kg/day for the next 2 days.
Group 2 will be observed and follow up echocardiography and PGE2 level will be followed up 3 days after treatment or follow up in both groups.
| Study group | Role | What they receive |
|---|---|---|
| group1, hemodynamically significant PDA | fulfilling the following criteria PDA measuring > 1.5 mm and predominantly left-to-right shunt. LA/Ao ratio between 1.4 and 1.6 in moderate PDA and >1.6 in large PDA. Left pulmonary artery (LPA) diastolic flow velocity of >0.25 m/sec. Systemic hypo perfusion: absent or reversed diastolic flow in the Aorta Group1will receive anti-PGE; Ibuprofen (IBU) (brufen)® syrup will be given for 3 days enterally either orally or via a gastric tube with an initial dose of 10mg/kg/day, followed by 5mg/kg/day for the next 2 days Receives: Drug: Ibuprofen (Brufen®) | |
| group2, hemodynamically insignificant PDA | Spontaneous closure group by echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore the relationship between PGE2 metabolite levels and the development of hemodynamically significant PDA in preterm neonates.
correlating the initial levels of PGE2 with the significance of PDA
Measured: initial PGE2 level on the first day of life and follow up the level after 3 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal PrematurityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mennatallah Ayman ayman, masters, Principal investigator, Neonatal intensive care units (NICUs), Ain Shams University, Abbasia, Cairo, Egypt, 11517
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338370
- Sponsor's protocol ID
- MD143/2025
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Prostaglandin E2 Metabolite Levels and the Development of Hemodynamically Significant Patent Ductus Arteriosus in Preterm Neonates
- ClinicalTrials.gov ID
- NCT07338370
- Acronym / sponsor ID
- MD143/2025
- Keywords
- cerebral blood flow, neonates, PDA, preterms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 13 Jan 2026 (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.
prospective observational cohort study to explore the relationship between PGE2 metabolite levels and the development of hemodynamically significant PDA in preterm neonates.
Detailed description
Regulation of ductus arteriosus involves (PGE2), produced by the placenta and DA itself, that promotes ductal patency by relaxing smooth muscle.
Prostaglandins are pluripotent lipid mediators derived from membrane glycerophospholipid metabolism. They are synthesized via a multienzyme cascade involving the actions of phospholipases and COX isoforms. Prostanoids, such as prostaglandin E2 and prostaglandin D2 metabolite (PGDM), are produced by various structural and inflammatory cells.
Cyclooxygenase inhibitors restrict the PDA by inhibiting the prostaglandin synthase enzyme, which prevents arachidonic acid from converting to prostaglandin. Acetaminophen is also believed to inhibit the prostaglandin synthesis enzyme's peroxidase portion, resulting in the PDA narrowing.
A significant decrease in serum PGE2 levels was observed following COX inhibitor treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group1, hemodynamically significant PDA | – | Drug: Ibuprofen (Brufen®)fulfilling the following criteria PDA measuring > 1.5 mm and predominantly left-to-right shunt. LA/Ao ratio between 1.4 and 1.6 in moderate PDA and >1.6 in large PDA. Left pulmonary artery (LPA) diastolic flow velocity of >0.25 m/sec. Systemic hypo perfusion: absent or reversed diastolic flow in the Aorta Group1will receive anti-PGE; Ibuprofen (IBU) (brufen)® syrup will be given for 3 days enterally either orally or via a gastric tube with an initial dose of 10mg/kg/day, followed by 5mg/kg/day for the next 2 days |
| group2, hemodynamically insignificant PDA | – | –Spontaneous closure group by echocardiography |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm neonates admitted to Ain shams University Hospital NICUs fulfilling the inclusion criteria
Key inclusion criteria (1 listed)
- Preterm neonates with gestational age ≤ 32 weeks, admitted to the NICU and diagnosed with patent ductus arteriosus by echocardiography on day 3 of life.
Key exclusion criteria (2 listed)
- Preterm neonates with evidence of any of the following will be excluded:
- Chromosomal anomaly or Congenital malformations Progressive intraventricular hemorrhage Congenital heart defect other than PDA and/or patent foramen ovale Pulmonary hypertension with right to left shunt on PDA Contraindications to the use of Ibuprofen: [1] Urine output <1 mL/kg/hour during preceding 8 hours. Serum creatinine >1.6 mg/dL. Platelet count <50 000/mm3. Abnormal coagulation profile. Necrotizing enterocolitis (NEC) or intestinal perforation
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 |
|---|---|---|
| Ibuprofen (Brufen®)Group1will receive anti-PGE; Ibuprofen (IBU) (brufen)® syrup will be given for 3 days enterally either orally or via a gastric tube with an initial dose of 10mg/kg/day, followed by 5mg/kg/day for the next 2 days. Group 2 will be observed and follow up echocardiography and PGE2 level will be followed up 3 days after treatment or follow up in both groups. | Drug | group1, hemodynamically significant PDA |
Primary outcome
Explore the relationship between PGE2 metabolite levels and the development of hemodynamically significant PDA in preterm neonates.
Time frame: initial PGE2 level on the first day of life and follow up the level after 3 days of treatment
correlating the initial levels of PGE2 with the significance of PDA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
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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.
Sondos Ahmed contact
Mennatallah Ayman ayman, masters principal investigator
Neonatal intensive care units (NICUs), Ain Shams University, Abbasia, Cairo, Egypt, 11517
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Prematurity and Patent Ductus Arteriosus in Preterm Infants, run by Ain Shams University at 1 site in Egypt.
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 2 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: looking for participants now, as of the sponsor's last update on 13 Jan 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mennatallah Ayman ayman, MD student (+201004137614, menahayman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore the relationship between PGE2 metabolite levels and the development of hemodynamically significant PDA in preterm neonates. (time frame: initial PGE2 level on the first day of life and follow up the level after 3 days of treatment). 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 13 Jan 2026.