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Montelukast in Very Low Birthweight Infants
This study is currently recruiting participants.
Verified by Children's Hospital Medical Center, Cincinnati, May 2008
First Received: June 25, 2007   Last Updated: May 9, 2008   History of Changes
Sponsor: Children's Hospital Medical Center, Cincinnati
Collaborator: Merck
Information provided by: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00492102
  Purpose

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).


Condition Intervention Phase
Bronchopulmonary Dysplasia
Drug: Montelukast
Phase I

Study Type: Interventional
Study Design: Basic Science, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title: Pharmacokinetics of Montelukast in Very Low Birthweight (VLBW) Preterm Infants

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Determine the pharmacokinetics of Montelukast in very low birth weight infants between 500 - 1500 g birth weight at risk for developing bronchopulmonary dysplasia [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Evaluate the preliminary safety of montelukast in pre-term neonates (single dose). [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: March 2007
Estimated Study Completion Date: March 2010
Arms Assigned Interventions
1: Experimental
One dose montelukast, either 0.2 mg or 0.3 mg, based on birth weight, followed by two blood draws for PK values
Drug: Montelukast
One dose montelukast, either 0.2 mg or 0.3 mg, based on birth weight, followed by two blood draws for PK values

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492102

Contacts
Contact: Suhas Kallapur, MD 513-636-3879 suhas.kallapur@cchmc.org
Contact: Anita Thoerner, RN, MSN, CNP 513-872-2627 Anita_Thoerner@TriHealth.com

Locations
United States, Ohio
Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45220-2489
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Merck
Investigators
Principal Investigator: Suhas Kallapur, MD CCHMC/Good Samaritan
  More Information

No publications provided

Responsible Party: Cincinnati Children's Medical Center
Study ID Numbers: CCHMC IRB# 05-05-22, TriHealth IRB# 05037-0505
Study First Received: June 25, 2007
Last Updated: May 9, 2008
ClinicalTrials.gov Identifier: NCT00492102     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:
pharmacokinetics
Montelukast
bronchopulmonary dysplasia
Pharmacokinetics of Montelukast

Additional relevant MeSH terms:
Montelukast
Birth Weight
Respiratory System Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Infant, Premature, Diseases
Pharmacologic Actions
Leukotriene Antagonists
Bronchopulmonary Dysplasia
Body Weight
Signs and Symptoms
Respiratory Tract Diseases
Therapeutic Uses
Lung Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on February 08, 2010