Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06905496

Apnea of Prematurity Results in Respiratory Distress and Cyanosis. Caffeine Citrate Can Treat It.

High-dose caffeine citrate is more effective than low-dose caffeine citrate in the treatment of apnea of prematurity (AOP). The high-dose group showed fewer apnea episodes, higher extubation success rate, lower extubation failure rate and shorter duration of oxygen therapy

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

About this study

Apnea of prematurity (AOP) is a common condition in preterm infants due to immature respiratory control, affecting up to 80% of those under 1000 grams. It can lead to serious complications, including respiratory distress, pulmonary hemorrhage, and developmental delays. Caffeine citrate, a methylxanthine, is widely used for AOP treatment due to its longer half-life and better absorption compared to theophylline. However, the optimal dosage remains uncertain, with varying practices globally.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Patients with a gestational age of ≥32 and <37 weeks at birth on LMP.
  • Diagnosis of apnea of prematurity (AOP) established as per operational definition within the first 10 days of life.
  • Either male or female patients

Exclusion criteria

  • • Patients diagnosed with Hydrops fetalis (evaluated through medical record).
  • Patients presenting with major congenital or chromosomal anomalies such as anencephaly, spina bifida, congenital heart defects (e.g., tetralogy of Fallot, transposition of the great arteries), or chromosomal disorders (e.g., trisomy 18, Turner syndrome).
  • Presence of a confirmed sepsis through blood culture.
  • Presence of a significant underlying neurological disorder evaluated by history and medical records that could contribute to apnea (e.g., intraventricular hemorrhage with posthemorrhagic hydrocephalus, hypoxic-ischemic encephalopathy)
  • Patients who have been previously treated with caffeine or other methylxanthines for apnea.

Treatment and study plan

High-Dose

Drug

Caffeine

Other names: Caffeine Citrate 40mg/kg/day

Low Dose

Drug

Caffeine citrate is a combination of caffeine and citric acid, commonly used as a central nervous system stimulant. It is primarily used to treat apnea of prematurity in neonates.

Primary outcomes

  1. Enhanced Respiratory Stimulation, Effect of Caffeine Citrate on the stimulation of respiratory system of premature individuals

    Time frame: 2-3 days after starting the intervention

    High dose vs low dose caffeine citrate effect in apnea of prematurity. The concentration of caffeine citrate as 40mg high dose and 20mg low dose will be considered. The measurement tool will be percentage of patients recovering from this high vs low concentration.

    The effect of caffeine citrate doses on respiratory stimulation of premature babies will be studied. High doses are expected to improve respiratory distress associated with prematurity. Patients will be clinically assessed after the given doses of caffeine citrate and any improvement, if present, will be noted.

Sponsors and collaborators

Lead sponsor

Nishtar Medical University

Other

Registry information

Official study title

Comparison of Outcomes of High Dose Verses Low Dose Caffeine Citrate in the Treatment of Apnea of Prematurity

Acronym: AOP

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 1, 2025
Registry last updated
Apr 1, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Published trials that share one or more normalized conditions with this study.