Montelukast in Very Low Birthweight Infants - Full Text View

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:	Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Pharmacokinetics of Montelukast in Very Low Birthweight (VLBW) Preterm Infants

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

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:	9
Study Start Date:	March 2007
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: 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. Other Name: Singulair

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

Locations

United States, Ohio
Good Samaritan Hospital
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:	Suhas Kallapur, MD, Cincinnati Children's Medical Center
ClinicalTrials.gov Identifier:	NCT00492102 History of Changes
Other Study ID Numbers:	CCHMC IRB# 05-05-22, TriHealth IRB# 05037-0505
Study First Received:	June 25, 2007
Last Updated:	June 24, 2011
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:

Birth Weight
Bronchopulmonary Dysplasia
Body Weight
Signs and Symptoms
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012