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OpenTrials
Completed

NCT Number: NCT06827197

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.

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Key information

Conditions

Premature Newborns Apnea Pathological Conditions, Signs and Symptoms Premature Newborns With Gestational Age 28 to 33 Weeks Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

1 day–2 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Benha University, Cairo, Al-Qalyubia, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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Blood samples were withdrawn from all the neonates under strict aseptic conditions and stored at -80°C for detecting PGE2 and IL-1β levels.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

Primary outcomes

  1. Duration of NICU stay

    Time frame: 1 month

  2. Mortality rate

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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