Greenville, NCNCT07101640Now EnrollingIRB Ready

Bronchopulmonary Dysplasia (BPD) Clinical Trial in Greenville, NC

Access cutting-edge bronchopulmonary dysplasia (bpd) treatment through this clinical trial at a research site in Greenville. Study-provided care at no cost to qualified participants.

Sponsored by Duke University

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Expert Care in Greenville

Access bronchopulmonary dysplasia (bpd) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related bronchopulmonary dysplasia (bpd) treatment provided free

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Check if you qualify for this bronchopulmonary dysplasia (bpd) clinical trial in Greenville, NC

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Why Participate?

  • No-Cost Study Care

  • Local to Greenville

    Convenient for NC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Greenville site if eligible
  4. 4Begin participation

About This Bronchopulmonary Dysplasia (BPD) Study in Greenville

The purpose of the study is to learn how safe montelukast may be in premature infants at significant risk for Bronchopulmonary Dysplasia (BPD) and to determine how much and how quickly montelukast moves from the stomach into the bloodstream, and how quickly it is removed from the bloodstream. Data supporting the prospect of montelukast benefit involved 6 previous studies involving 206 preterm infants. The dosing ranged from 0.5 to 2.5 mg/kg/day, which aligns with the proposed initial dose of 0.75 mg/kg/day. Though each previous study had a small population, collectively they reveal montelukast as a promising drug in populations of preterm infants developing BPD and for individual preterm infants who are "developing BPD." Thus, researchers expect clinical benefit for preterm infants in this study. Despite the benefit-to-risk ratio presented by these previous studies, the optimal dose remains to be determined; thus, this study design and PK analysis will start with the lowest dose that is likely to provide direct benefit to participants.

Sponsor: Duke University

Who Can Participate

Inclusion Criteria

Documented informed consent from parent or guardian, prior to study activities
Receiving mechanical ventilation \[high frequency or conventional\] and requiring supplemental oxygen (FiO2 ≥ 30%) at time of randomization
\<28 weeks' gestational age and \<1000 g bodyweight at birth
7 to 28 (inclusive) days postnatal age at the time of first study drug dose
Able to tolerate 5 mL of enteral volume

Exclusion Criteria

Previous enrollment and dosing in the current PRISM study (NICHD-2023-MON01)
Previous exposure to montelukast within 7 days prior to randomization
Known allergy to montelukast
PI deems infant - prior to enrollment - is not expected to survive
Has a disease complication that would preclude safe participation of the participant
Increased respiratory support due to intercurrent illness (e.g., sepsis, necrotizing enterocolitis, etc.). Infants should be excluded from the study until after resolution of the acute event
Congenital lung and diaphragmatic malformations

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Greenville?

Yes, this clinical trial (NCT07101640) has an active research site in Greenville, NC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Bronchopulmonary Dysplasia (BPD) Treatment Options in Greenville, NC

If you're searching for bronchopulmonary dysplasia (bpd) treatment options in Greenville, NC, this clinical trial (NCT07101640) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Greenville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced bronchopulmonary dysplasia (bpd) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all bronchopulmonary dysplasia (bpd) clinical trials near you to find additional studies recruiting in your area.

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