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

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: Premature Newborns With Gestational Age 28 to 33 Weeks; Premature Newborns
• Intervention / Treatment: Diagnostic test: Blood test

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

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: Outcome; Interleukin-1β; Apnea of prematurity; Prostaglandin E2
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• 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