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Caffeine Citrate to Improve Neonatal Outcomes.

NCT06972849 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3900

Last updated 2025-05-15

No results posted yet for this study

Summary

The goal of this clinical trial to learn what dose/s of caffeine citrate works to treat preterm born babies who have episodes where they stop breathing. It will also learn about the safety of different doses of caffeine citrate for the variety of preterm-born babies that are prescribed this.

The main question it aims to answer is: Which dose is the optimal dose of caffeine citrate for very preterm babies to prevent short-term death and disease?

Researchers will compare three different doses of caffeine citrate, which are already used in clinical practice to treat breathing stoppages in preterm babies, to see which dose works best. No placebo will be used.

Participants will be given a 'loading' dose of caffeine citrate \<72 hours of life, and a smaller 'maintenance' dose once a day, for as long as the baby needs this.

This trial will be undertaken as part of the PLATIPUS trial (NCT06461429).

Conditions

  • Apnea of Prematurity

Interventions

DRUG

Caffeine citrate

Clinically indicated for apnea of prematurity.

Sponsors & Collaborators

Principal Investigators

  • Brett Manley, MBChB PhD · University of Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2029-12-31
Completion
2050-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06972849 on ClinicalTrials.gov