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

NCT06827197 | Completed

• 1 other identifier: MS 4-5-2023
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Premature Newborns; Premature Newborns With Gestational Age 28 to 33 Weeks

Keywords

Apnea of prematurity; Interleukin-1β; Prostaglandin E2; Outcome

Outcome Measures

Primary Outcomes (2)

• Duration of NICU stay

  1 month

• Mortality rate

  1 month

Interventions

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Blood samples were withdrawn from all the neonates under strict aseptic conditions and stored at -80°C for detecting PGE2 and IL-1β levels.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

Eligibility Criteria

• Age: 1 Day - 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (2)

Benha University

Cairo, Al-Qalyubia, 13511, Egypt

Location

Amany El-Rebigi

Banhā, Egypt

Location

MeSH Terms

Conditions

Apnea

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatrics, Faculty of Medicine, Benha University, Benha, Egypt

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: May 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 30, 2023
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)