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NCT06327152 · ClinicalTrials.gov registry record · Phase 2

Caffeine Use in the Management of Preterm Infants

A Phase 2 study of Apnea of Prematurity, sponsored by University of California, Irvine.

Active
Registry status
Phase 2
Development phase
80
Enrollment target
1
Study location

NCT06327152: Active Phase 2 study of Apnea of Prematurity, sponsored by University of California, Irvine.

NCT06327152 is a Phase 2 study of Apnea of Prematurity that is active but no longer recruiting, run by University of California, Irvine. The registered enrollment target is 80 participants, below the 395-participant average among 6 other Apnea of Prematurity trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06327152, a Phase 2 study of Apnea of Prematurity, is active but no longer recruiting, sponsored by University of California, Irvine.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
80 participants
Enrollment target
1
Study location

Study Summary

This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster.

Primary Outcome

The primary outcome is time (in days) to full oral bottle feeding or breastfeeding or a combination of both. Full oral bottle feeding is defined as 48 hours of consistent intake of at least 150ml/kg/day of formula or breastmilk. If the subject is on combination of bottle and breastfeeding, two consecutive days of positive weight gain will be used in place of 150ml/kg/day as primary outcome measure.

Conditions Studied

Interventions

  • DRUG Caffeine
  • OTHER Sterile Water Placebo

Study Locations (1)

California

  • UC Irvine Medical Center - Orange

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2024-02-22
Est. Completion 2026-12-31
Phase Phase 2
University of California, Irvine

368 total trials

What the registry record for NCT06327152 still lists

NCT06327152 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 395-participant average among 6 other Apnea of Prematurity trials with a reported enrollment target (80% lower).

The record links to 1 condition, with Apnea of Prematurity appearing as the primary indexed condition, and to 2 interventions - of which Caffeine is the first listed.

NCT06327152 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT06327152 about?

NCT06327152 is a clinical study titled "Caffeine Use in the Management of Preterm Infants". This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster.

What is the current status of trial NCT06327152?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2024-02-22. Estimated completion is 2026-12-31.

What conditions does trial NCT06327152 study?

This clinical trial studies the following conditions: Apnea of Prematurity.

What interventions are being tested in trial NCT06327152?

The interventions under investigation include: Caffeine (DRUG), Sterile Water Placebo (OTHER).

Who is sponsoring clinical trial NCT06327152?

This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06327152 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT06327152, the US trial registry maintained by the National Library of Medicine. NCT06327152 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.