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Completed

NCT Number: NCT05898022

Pragmatic Research on Diuretic Management in Early BPD Pilot

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?

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Thoracic Injuries Ventilator-Induced Lung Injury Wounds and Injuries

Age range

2 week–10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory University, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • <28 weeks gestation at birth
  • Post-Menstrual Age (PMA) of 29-32 weeks gestation
  • Requiring invasive positive pressure respiratory support or NIPPV/NIMV and FiO2 ≥ 25% or requiring non-invasive positive pressure respiratory support (NCPAP≥ 5 cm H20, 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

Exclusion criteria

  • Major congenital anomalies (e.g., known renal anomalies, congenital heart disease, congenital diaphragmatic hernia, or chromosomal anomalies)
  • In infants who had electrolyte testing in the week prior to enrollment, those with a serum creatinine > 1.7 mg/dL, BUN >50 mg/dL, Na <125 mmoL/L, K ≤ 2.5 mmol/L, or Ca ≤ 6 mg/dL. Not having electrolyte testing in the week prior to enrollment is not an exclusion criterion.
  • Current treatment with Dexamethasone or hydrocortisone for respiratory failure. Treatment with chronic steroids for history of adrenal insufficiency or cardiovascular instability is not an exclusion criterion.
  • Treatment with any longer-acting diuretic (e.g., chlorothiazide, hydrochlorothiazide, acetazolamide) within 5 days of enrollment where exposure may result in carryover effects that confound the N-of-1 trial
  • Active order for standing, regularly scheduled diuretics (e.g., chronic diuretics)
  • Non-English speaking
  • Current treatment with ibuprofen or indocin

Treatment and study plan

Furosemide (plus potassium chloride)

Drug

Furosemide is a loop diuretic that inhibits the reabsorption of sodium and chloride in the proximal and distal tubules as well as the loop of Henle. Participants will receive 2 mg/kg enteral furosemide daily during treatment periods when they receive study drug. To prevent hypokalemia and hypochloremia associated with furosemide use, participants will also receive 1 mg/kg of potassium chloride enterally twice per day when receiving furosemide. Each patient will have 8 days of total exposure to furosemide over the 16-day N-of-1 trial.

Placebo (plus placebo electrolyte solution)

Drug

During treatment periods when participants receive placebo, they will receive a volume of sterile water equivalent to the study drug dose. Participants will also receive a placebo electrolyte solution equivalent to the volume of potassium chloride that would be given.

Primary outcomes

  1. Percent of Enrolled Infants Who Completed the Full N-of-1 Trial, Remain on Respiratory Support at the Conclusion of the N-of-1 Trial, and Were Identified as a Responder

    Time frame: 23 Days

  2. Percent of Providers Willing to Support Randomizing a Responder Infant

    Time frame: 30 Days

Secondary outcomes

  1. Percent of Enrolled Infants Completing Full N-of-1 Trial and Identified as Responder

    Time frame: 23 days

  2. Percent of Enrolled Infants Completing Full N-of-1 Trial

    Time frame: 23 days

  3. Percent of Enrolled Infants on Respiratory Support at the Conclusion of the N-of-1 Trial

    Time frame: 23 days

  4. Rate of Chronic Diuretic Use Among Responders

    Time frame: 30 days

  5. Rate of Chronic Diuretic Use Among Non-responders

    Time frame: 30 days

  6. Percent of Parents Willing to Randomize Responder Infant

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Emory University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • RTI International
  • Rainbow Babies and Children's Hospital

Registry information

Official study title

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

Acronym: PRIMED

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2023
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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