Pragmatic Research on Diuretic Management in Early Bronchopulmonary Dysplasia (PRIMED) Pilot Study

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Babies who are born prematurely often develop a chronic lung disease called bronchopulmonary dysplasia (BPD). BPD puts babies at higher risk for problems with growth and development. Diuretics, such as furosemide, are frequently used in the management of early BPD). Many clinicians use informal trials of therapy to see if a baby responds to diuretics in the short-term before starting chronic diuretic therapy. Despite frequent use of diuretics, it is unclear how many babies truly respond to therapy and if there are long-term benefits of diuretic treatment. Designing research studies to figure this out has been challenging. The Pragmatic Research on Diuretic Management in Early BPD (PRIMED) study is a feasibility pilot study to help us get information to design a larger trial of diuretic management for BPD. Key questions this study will answer include: (1) Can we use an N-of-1 trial to determine whether a particular baby responds to furosemide? In an N-of-1 trial, a baby is switched between furosemide and placebo to compare that particular infant's response on and off diuretics. It is a more rigorous approach to the informal trials of therapy that are often conducted in clinical care. We hope to learn how many babies have a short-term response to furosemide (responders); (2) how many babies will still be on respiratory support at the end of the N-of-1 trial? This will help us determine how many patients would be eligible to randomize to chronic diuretic therapy in the second phase of the larger trail, and (3) if a baby is identified as a short-term responder, how many parents and physicians would be willing to randomize the baby to chronic diuretics (3 months) versus placebo in the longer trial?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14 days
Maximum Age: 2 months
Healthy Volunteers: f
View:

• \<28 weeks gestation at birth

• Post-Menstrual Age (PMA) of 29-32 weeks gestation

• Requiring invasive positive pressure respiratory support and FiO2 ≥ 25% or requiring non-invasive positive pressure respiratory support (NCPAP≥ 5 cm H20, NIPPV/BiPhasic CPAP) and FiO2 ≥ 30%.

• Receiving enteral feedings of 120 mL/kg/day or greater

• Expected to be hospitalized for at least 28 days after enrollment

Locations
United States
Georgia
Emory University
RECRUITING
Atlanta
North Carolina
RTI International
ACTIVE_NOT_RECRUITING
Durham
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Case Western Reserve University, Rainbow Babies and Children's Hospital
RECRUITING
Cleveland
Contact Information
Primary
Heather Kaplan, MD, MSCE
heather.kaplan@cchmc.org
513-803-0478
Backup
Anna Maria Hibbs, MD, MSCE
annamaria.hibbs@uhhospitals.org
216-844-3387
Time Frame
Start Date: 2023-08-17
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 30
Treatments
Other: N-of-1 Trial
Each individual N-of-1 trial will have 2 blocks. In each block patients will crossover between furosemide (plus potassium chloride) for 1 week and placebo (plus placebo electrolyte solution) for 1 week. The total arm length (length of the N-of-1 Trial/Crossover) is 28 days. Patients may receive furosemide (plus potassium chloride) and placebo (plus placebo electrolyte solution) in one of four different treatment order sequences, however, treatment order will not be analyzed for the primary outcomes of feasibility/responder status.
Sponsors
Collaborators: Emory University, RTI International, Rainbow Babies and Children's Hospital, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov

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