Montelukast in Very Low Birthweight Infants
Information source: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchopulmonary Dysplasia
Intervention: Montelukast (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Children's Hospital Medical Center, Cincinnati Official(s) and/or principal investigator(s): Suhas Kallapur, MD, Principal Investigator, Affiliation: CCHMC/Good Samaritan
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).
Clinical Details
Official title: Pharmacokinetics of Montelukast in Very Low Birthweight (VLBW) Preterm Infants
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Determine the pharmacokinetics of Montelukast in very low birth weight infants between 500 - 1500 g birth weight at risk for developing bronchopulmonary dysplasiaEvaluate the preliminary safety of montelukast in pre-term neonates (single dose).
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Good Samaritan Hospital, Cincinnati, Ohio 45220-2489, United States
Additional Information
Starting date: March 2007
Last updated: August 1, 2012
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