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Montelukast in Very Low Birthweight Infants

NCT ID: NCT00492102

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-06-30

Brief Summary

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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).

Detailed Description

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This study proposal will determine the pharmacokinetics (PK) of montelukast (cysteinyl leukotriene receptor-1 or CysLT1 inhibitor) in very low birth weight (VLBW) infants between 500 - 1500g birth weight at risk for developing bronchopulmonary dysplasia (BPD). Montelukast (Singulair) is a FDA approved specific CysLT1 antagonist widely used clinically in the prophylaxis of asthma in children older than 12 months of age and blocks leukotriene signaling in the lung. BPD shares some pathogenic mechanisms with asthma, however Cysteinyl LT receptor blockade has not been studied in preterm infants. Montelukast is metabolized by the cytochrome P450 system which is immature in the preterm infant and hence the need for this study. The investigators' long-term hypothesis is that inhibition of leukotriene signaling in the VLBW preterm lung will decrease inflammation, remodeling and the incidence of BPD. The data will be used to design future efficacy trials of Montelukast in the prevention of bronchopulmonary dysplasia.

Conditions

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Bronchopulmonary Dysplasia

Keywords

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pharmacokinetics Montelukast bronchopulmonary dysplasia Pharmacokinetics of Montelukast

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Nine VLBW pre-term infants older than 7 days will be enrolled in the study and receive one oral dose of Montelukast based on weight. Two blood samples will be obtained from each infant within 24 hours of the drug administration and plasma Montelukast levels will be determined.

Group Type EXPERIMENTAL

Montelukast

Intervention Type DRUG

One oral dose of Montelukast 0.15mg (infants weighing 500-1000gm) or 0.2mg (infants weighing \>1000gm). Two blood samples will be obtained from each infant within 24 hours of the drug administration and plasma Montelukast levels will be determined.

Interventions

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Montelukast

One oral dose of Montelukast 0.15mg (infants weighing 500-1000gm) or 0.2mg (infants weighing \>1000gm). Two blood samples will be obtained from each infant within 24 hours of the drug administration and plasma Montelukast levels will be determined.

Intervention Type DRUG

Other Intervention Names

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Singulair

Eligibility Criteria

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Inclusion Criteria

* VLBW infants between 500 - 1500 gm birth-weight born at Good Samaritan Hospital, Cincinnati, tolerating oral feeds equal to or more than 75 ml/kg/day and older than 7 days

Exclusion Criteria

* Infants diagnosed with congenital malformations.
* Infants with an acute life threatening illness.
* Grade III or IV intra-ventricular hemorrhage.
* Patent ductus arteriosus being treated with indomethacin.
* Oral feedings are contra-indicated.
* Parents refuse consent.
* Attending physician does not wish the infant to be enrolled in the study.
* Infants with known hepatitis or HIV.
* Infants enrolled in any study using an investigational drug.
Minimum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suhas Kallapur, MD

Role: PRINCIPAL_INVESTIGATOR

CCHMC/Good Samaritan

Locations

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Good Samaritan Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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TriHealth IRB# 05037-0505

Identifier Type: OTHER

Identifier Source: secondary_id

CCHMC IRB# 05-05-22

Identifier Type: -

Identifier Source: org_study_id