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NCT02447250 · ClinicalTrials.gov registry record · Phase 4

Preterm Infant Inhaled Albuterol Dosing

A Phase 4 study, sponsored by Oregon Health and Science University.

Completed
Registry status
Phase 4
Development phase
14
Enrollment target

NCT02447250: Completed Phase 4 study, sponsored by Oregon Health and Science University.

NCT02447250 is a Phase 4 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02447250, a Phase 4 study, has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
Phase 4
Development phase
14 participants
Enrollment target

Study Summary

The purpose of this study is to help determine the best dose of inhaled albuterol sulfate in premature babies at risk of developing bronchopulmonary dysplasia (BPD). BPD is the chronic lung disease of prematurity and is associated with increased morbidity and mortality, longer hospital stays, and increased healthcare utilization. Albuterol is an inhaled medication frequently used in premature infants with chronic lung disease and in people with asthma. It is believed to be safe, but the optimal dose for infants is not clear. The investigators hypothesize that albuterol may help a subset of premature infants with lung disease, but they need to determine the best dose prior to doing research about how effective it is for chronic lung disease/BPD. Response to each of three doses of albuterol will be measure using pulmonary function tests.

Primary Outcome

The primary outcome is the percentage of subjects who show a positive response to each dose of albuterol. A positive response is defined as a greater than or equal to 10% decrease in respiratory resistance (Rrs). The change in RRs was measured at baseline and again after each dose of albuterol. All measurements were taken within a 7 day time frame for each subject such that each subject would have up to 3 results measured during a 7 day period, if he/she were able to complete three sets of PFTs

Interventions

  • DRUG Varied albuterol dose response

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2013-10-24
Est. Completion 2014-12-30
Phase Phase 4

What the finished NCT02447250 record still lists

NCT02447250 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Varied albuterol dose response is the first listed.

NCT02447250 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02447250 about?

NCT02447250 is a clinical study titled "Preterm Infant Inhaled Albuterol Dosing". The purpose of this study is to help determine the best dose of inhaled albuterol sulfate in premature babies at risk of developing bronchopulmonary dysplasia (BPD). BPD is the chronic lung disease of prematurity and is associated with increased morbidity and mortality, longer hospital stays, and in...

What is the current status of trial NCT02447250?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2013-10-24. Estimated completion is 2014-12-30.

What interventions are being tested in trial NCT02447250?

The interventions under investigation include: Varied albuterol dose response (DRUG).

Who is sponsoring clinical trial NCT02447250?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02447250's enrollment target sits among peer trials

14 1901st of 2000 higher than 91 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02447250, the US trial registry maintained by the National Library of Medicine. NCT02447250 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.