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

Nishtar Medical University

Status and phase: Active, not recruiting; Phase 1

Conditions: Apnea of Prematurity

Treatments: Drug: Low Dose; Drug: High-Dose

Study type: Interventional

Funder types: Other

Identifiers

NCT06905496

Nishtar Hospital Multan (Other Identifier)

HDLDCC2025

Details and patient eligibility

About

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

Full description

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.

Enrollment: 114 patients

Sex: All

Ages: 1 to 10 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 2 patient groups

High-Dose Group

Experimental group

Description:

High dose group will be administered a loading dose of oral caffeine citrate at 40 mg/kg/day followed by a maintenance dose of 20 mg/kg/day for 7 days

Treatment:

Drug: High-Dose

Drug: Low Dose

Low-Dose Group

Experimental group

Description:

Low-dose group will receive a loading dose of 20 mg/kg/day and a maintenance dose of 10 mg/kg/day for 7 days

Treatment:

Drug: High-Dose

Drug: Low Dose