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

March 25, 2025 updated by: Fatima Zahra, Nishtar Medical University

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Multan, Punjab, Pakistan, 60000
        • Nishtar Medical Hospital, Multan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-Dose Group
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
Drug: High-Dose
Caffeine
Other Names:
  • Caffeine Citrate 40mg/kg/day
Drug: Low Dose
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.
Experimental: Low-Dose Group
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
Drug: High-Dose
Caffeine
Other Names:
  • Caffeine Citrate 40mg/kg/day
Drug: Low Dose
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2-3 days after starting the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nishtar Medical University

Investigators

  • Study Chair: Fatima Zahra, FCPS, Nishtar Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

March 1, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDLDCC2025
  • Nishtar Hospital Multan (Other Identifier: Nishtar Hospital Multan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient privacy will be our priority. Consent will be taken from patient for participation in study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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