CompletedNot Applicable

Role of Interleukin-1β and Prostaglandin E2 in Prediction and Outcome of Apnea in Neonates

Egypt100 participantsStarted 2023-05-01

Plain-language 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.

Who can participate

Age range

1 Day – 2 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of NICU stay

Timeframe: 1 month

Mortality rate

Timeframe: 1 month

Trial details

NCT IDNCT06827197

SponsorBenha University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-10-01

View on ClinicalTrials.gov More Premature Newborns trials

Who can participate

Age range

1 Day – 2 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.