Premature NewbornsNCT06827197
Role of Interleukin-1β and Prostaglandin E2 in Prediction and Outcome of Apnea in Neonates
An observational study of Premature Newborns and Premature Newborns With Gestational Age 28 to 33 Weeks, run by Benha University at 2 sites in Egypt.
Trial summary
Our thesis proposed that IL-1β may affect brainstem respiratory control via prostaglandin-dependant mechanism so we investigated the mediator roles of IL-1β and PGE2 levels in predicting apnea in pretertm newborn and their relation to clinical outcomes. Read more about this study
- Who is it for?
- Ages 1 day to 2 months
- Conditions the study is for
- Premature Newborns, Premature Newborns With Gestational Age 28 to 33 Weeks
- What is being tested?
- Blood test
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2023to 30 Oct 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 2 months
- All sexes
- No healthy volunteers
- Child
Study population: This study included 100 preterm neonates who were recruited from the Neonatal Intensive Care Unit, Pediatric Department of Benha University Hospital, during the period from May 2023 till October 2023. They were eligible for the study and their parents agreed to participate in the study.
Who may be able to join
- Preterm infants born at less than 37 weeks of gestation.
- Neonates aged from birth up to 28 days.
- Neonates diagnosed with apnea of prematurity or exhibiting apneic episodes
Who cannot join
- Full-term neonates.
- Neonates with major congenital malformations or genetic syndromes.
- Neonates with severe neurological impairments (e.g., intraventricular hemorrhage grade III or IV).
- Neonates with confirmed or suspected sepsis or active infections.
- Neonates receiving steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other medications known to alter interleukin-1β or prostaglandin E2 levels.
- Neonates with congenital heart diseases.
- Neonates with a history of significant birth asphyxia requiring extensive resuscitation.
- Neonates whose parents or guardians refuse to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
About this study
Our thesis proposed that IL-1β may affect brainstem respiratory control via prostaglandin-dependant mechanism so we investigated the mediator roles of IL-1β and PGE2 levels in predicting apnea in pretertm newborn and their relation to clinical outcomes.
- Being tested
- Blood test
- Keywords
- Apnea of prematurity, Interleukin-1β, Prostaglandin E2, Outcome
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDiagnostic test
Blood samples were withdrawn from all the neonates under strict aseptic conditions and stored at -80°C for detecting PGE2 and IL-1β levels. PGE2 and IL-1β concentrations were measured using ELISA.
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of NICU stay
Measured: 1 month
Mortality rate
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 May 2023
- Primary completion1 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature NewbornsStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Mohammed El-Rebigi, MD, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827197
- Sponsor's protocol ID
- MS 4-5-2023
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Interleukin-1β and Prostaglandin E2 in Prediction and Outcome of Apnea in Neonates
- ClinicalTrials.gov ID
- NCT06827197
- Acronym / sponsor ID
- MS 4-5-2023
- Keywords
- Apnea of prematurity, Interleukin-1β, Prostaglandin E2, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 14 Feb 2025 (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.
Our thesis proposed that IL-1β may affect brainstem respiratory control via prostaglandin-dependant mechanism so we investigated the mediator roles of IL-1β and PGE2 levels in predicting apnea in pretertm newborn and their relation to clinical outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 1 day to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study included 100 preterm neonates who were recruited from the Neonatal Intensive Care Unit, Pediatric Department of Benha University Hospital, during the period from May 2023 till October 2023. They were eligible for the study and their parents agreed to participate in the study.
Key inclusion criteria (3 listed)
- Preterm infants born at less than 37 weeks of gestation.
- Neonates aged from birth up to 28 days.
- Neonates diagnosed with apnea of prematurity or exhibiting apneic episodes
Key exclusion criteria (8 listed)
- Full-term neonates.
- Neonates with major congenital malformations or genetic syndromes.
- Neonates with severe neurological impairments (e.g., intraventricular hemorrhage grade III or IV).
- Neonates with confirmed or suspected sepsis or active infections.
- Neonates receiving steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other medications known to alter interleukin-1β or prostaglandin E2 levels.
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 |
|---|---|---|
| Blood testBlood samples were withdrawn from all the neonates under strict aseptic conditions and stored at -80°C for detecting PGE2 and IL-1β levels. PGE2 and IL-1β concentrations were measured using ELISA. | Diagnostic test | – |
Primary outcome
Duration of NICU stay
Time frame: 1 month
Mortality rate
Time frame: 1 month
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 14 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Newborns and Premature Newborns With Gestational Age 28 to 33 Weeks, run by Benha University at 2 sites 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 3 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 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Duration of NICU stay (time frame: 1 month). The study lists 2 primary outcomes in all. 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 14 Feb 2025.