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

February 10, 2025 updated by: Amany Mohammed El-Rebigi, MD, Benha University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Banhā, Egypt
        • Amany El-Rebigi
    • Al-Qalyubia
      • Cairo, Al-Qalyubia, Egypt, 13511
        • Benha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of NICU stay
Time Frame: 1 month
1 month
Mortality rate
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS 4-5-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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