Metformin for Bronchopulmonary Dysplasia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if metformin, a medication commonly used for diabetes, can protect and promote lung growth in premature infants with bronchopulmonary dysplasia (BPD). Researchers are assessing how well premature babies tolerate metformin to establish a safe dose. The trial consists of two parts: one for older premature babies already diagnosed with BPD and another for extremely premature babies at risk of developing it. Parents of premature infants born before 29 weeks who face lung issues and require breathing support might consider this trial. As an Early Phase 1 trial, this research focuses on understanding metformin's effects in premature infants, offering a chance to contribute to groundbreaking knowledge in neonatal care.
Do I need to stop my current medications for the trial?
The trial information does not specify whether participants need to stop their current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that metformin is likely to be safe for premature infants?
Research shows that metformin is usually safe for use. Studies have found that metformin can reduce lung injury and inflammation, potentially protecting lung health by lowering inflammation and preventing damage to lung tissue. This potential makes it a candidate for treating conditions like bronchopulmonary dysplasia (BPD) in premature babies.
However, this trial is in its early stages, and specific information about how very premature babies handle it is limited. Early trials primarily focus on safety, so more will be learned as the study progresses. Metformin is already used safely for other conditions, such as diabetes, providing some confidence in its safety. Since premature babies might react differently, researchers will monitor them closely.12345Why do researchers think this study treatment might be promising for bronchopulmonary dysplasia?
Researchers are excited about using Metformin for bronchopulmonary dysplasia because it offers a novel approach compared to standard treatments. Most existing therapies for this condition focus on managing symptoms and include oxygen therapy and mechanical ventilation. Metformin, however, is known for its anti-inflammatory and antioxidant properties, which might directly address the underlying inflammation and oxidative stress involved in bronchopulmonary dysplasia. This could potentially lead to improved outcomes by targeting the root causes rather than just alleviating symptoms. Additionally, Metformin is a well-known medication, primarily used for diabetes, which might allow for a faster and safer transition into treating this new indication.
What evidence suggests that metformin might be an effective treatment for bronchopulmonary dysplasia?
Research has shown that metformin might help with lung problems in premature babies, such as bronchopulmonary dysplasia (BPD). Studies have found that metformin can lessen lung damage by reducing swelling and scarring in the lungs. It also seems to support better lung growth by lowering stress and harm in lung cells. Early results suggest that metformin might improve lung conditions by calming the body's defense system when it overreacts. This trial will explore different dosages of metformin to determine its effectiveness and safety for lung issues in premature infants.12567
Who Is on the Research Team?
G. Ganesh Konduri, MD, MS
Principal Investigator
Medical College of Wisconsin
Are You a Good Fit for This Trial?
This trial is for premature infants diagnosed with bronchopulmonary dysplasia (BPD). It includes two phases: older preemies at 36-44 weeks gestation and extremely young preemies who are 7-30 days old with a high risk of BPD. Specific eligibility criteria details were not provided.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 0 Treatment
Participants receive oral metformin in varying doses for 3, 7, or 14 days to assess safety and tolerance in premature infants with BPD
Phase 1 Treatment
Participants receive oral metformin in varying doses for 3, 7, or 14 days to assess safety and tolerance in extremely premature infants at risk of BPD
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and pharmacokinetic evaluations
What Are the Treatments Tested in This Trial?
Interventions
- Metformin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor