Montelukast in Very Low Birthweight Infants

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Brief Title

Montelukast in Very Low Birthweight Infants

Official Title

Pharmacokinetics of Montelukast in Very Low Birthweight (VLBW) Preterm Infants

Brief 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).
    

Detailed Description

      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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Determine the pharmacokinetics of Montelukast in very low birth weight infants between 500 - 1500 g birth weight at risk for developing bronchopulmonary dysplasia


Condition

Bronchopulmonary Dysplasia

Intervention

Montelukast

Study Arms / Comparison Groups

 1
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

9

Start Date

March 2007

Completion Date

June 2011

Primary Completion Date

June 2011

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Suhas Kallapur, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00492102

Organization ID

CCHMC IRB# 05-05-22

Secondary IDs

TriHealth IRB# 05037-0505

Responsible Party

Sponsor

Study Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

 Merck Sharp & Dohme Corp.

Study Sponsor

Suhas Kallapur, MD, Principal Investigator, CCHMC/Good Samaritan


Verification Date

August 2012