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

NCT ID: NCT06827197

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Premature Newborns Premature Newborns With Gestational Age 28 to 33 Weeks

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Blood 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Blood samples were withdrawn from all the neonates under strict aseptic conditions and stored at -80°C for detecting PGE2 and IL-1β levels.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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Amany Mohammed El-Rebigi, MD

Lecturer of Pediatrics, Faculty of Medicine, Benha University, Benha, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Benha University

Cairo, Al-Qalyubia, Egypt

Site Status

Amany El-Rebigi

Banhā, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS 4-5-2023

Identifier Type: -

Identifier Source: org_study_id

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