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NCT00492102 · ClinicalTrials.gov registry record · Phase 1

Montelukast in Very Low Birthweight Infants

A Phase 1 study of Bronchopulmonary Dysplasia, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
Phase 1
Development phase
9
Enrollment target
1
Study location

NCT00492102 is a Phase 1 study of Bronchopulmonary Dysplasia that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 9 participants, below the 236-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00492102, a Phase 1 study of Bronchopulmonary Dysplasia, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
Phase 1
Development phase
9 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine the pharmacokinetics (PK) of montelukast (Singulair) in very low birth weight (VLBW) infants at risk for developing bronchopulmonary dysplasia (the need for supplemental oxygen). The investigators' long-term hypothesis is that inhibition of leukotriene signaling in the VLBW preterm lung will decrease inflammation, remodeling and the incidence of bronchopulmonary dysplasia (BPD).

Conditions Studied

Interventions

  • DRUG Montelukast

Study Locations (1)

Ohio

  • Good Samaritan Hospital - Cincinnati

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2007-03
Est. Completion 2011-06
Phase Phase 1

What the Registry Record Tells You About NCT00492102

The ClinicalTrials.gov registry entry for NCT00492102 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 236-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (96% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Bronchopulmonary Dysplasia appearing as the primary indexed condition, and to 1 intervention - of which Montelukast is the first listed.

NCT00492102 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT00492102 about?

NCT00492102 is a clinical study titled "Montelukast in Very Low Birthweight Infants". The purpose of this study is to determine the pharmacokinetics (PK) of montelukast (Singulair) in very low birth weight (VLBW) infants at risk for developing bronchopulmonary dysplasia (the need for supplemental oxygen). The investigators' long-term hypothesis is that inhibition of leukotriene signa...

What is the current status of trial NCT00492102?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2007-03. Estimated completion is 2011-06.

What conditions does trial NCT00492102 study?

This clinical trial studies the following conditions: Bronchopulmonary Dysplasia.

What interventions are being tested in trial NCT00492102?

The interventions under investigation include: Montelukast (DRUG).

Who is sponsoring clinical trial NCT00492102?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00492102 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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