Metformin for Premature Infants With Bronchopulmonary Dysplasia

DRUG

Metformin (open-label)

Enteric metformin 5mg/kg/day in two divided doses will be given for three days to two subjects

DRUG

Metformin (open-label)

Enteric metformin 10mg/kg/day in two divided doses will be given for three days to two subjects.

DRUG

Metformin (open-label)

Enteric metformin 20mg/kg/day in two divided doses will be given for seven days to three subjects.

DRUG

Metformin (open-label)

Enteric metformin 25mg/kg/day in two divided doses will be given for 14 days to three subjects.

DRUG

Metformin (open-label)

Enteric metformin 15mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, the next Cohort will increase to 25mg/kg/day (Cohort 2) or decrease to 10mg/kg/day (Cohort 3)

DRUG

Metformin (open-label)

Enteric metformin 25mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, either 25mg/kg/day or 15mg/kg/day will be dose selected for the next Cohort (Cohort 4)

DRUG

Metformin (open-label)

Enteric metformin 10mg/kg/day in a single daily dose will be given for three days to 3-6 subjects. Depending on tolerance, either 10mg/kg/day dose selected for the next Cohort (Cohort 4) or the study will be stopped due to excessive toxicity.

DRUG

Metformin (open-label)

The dose for this cohort will be selected from either Cohort 2 or 3 based on tolerance. Enteric metformin 10-25mg/kg/day in a single daily dose will be given for seven days to 6 subjects.

DRUG

Metformin (open-label)

The dose for this cohort will be the same as Cohort 4. Enteric metformin 10-25mg/kg/day in a single daily dose will be given for 14 days to 6 subjects.

Number of participants who tolerate metformin

Time frame: 14 days after administration of the first dose of metformin

Number of subjects who receive enteral doses of metformin and complete the study days without an adverse event while continuing enteral feedings

Number of participants with treatment-related adverse events

Time frame: 14 days after administration of the first dose of metformin

Number of participants who develop hypoglycemia defined as blood glucose value \<50

Number of participants with treatment-related metabolic acidosis

Time frame: 14 days after administration of the first dose of metformin

Number of subjects who develop lactic acid levels \> 5mmol/L

Number of subjects with treatment-related feeding problems

Time frame: 14 days after administration of the first dose of metformin

Number of subjects who require a decrease in enteral feeding volume by \>50% from baseline

Number of subjects who require dose adjustments of metformin

Time frame: 14 days after administration of the first dose of metformin

Number of subjects who need decreases in dose or discontinuation of metformin due to hepatic or renal dysfunction

Number of subjects with respiratory deterioration

Time frame: 14 days after administration of the first dose of metformin

Number of subjects who develop pneumonia and increases in oxygen concentration and ventilator support during the study

Number of subjects who complete pharmacokinetic evaluation of metformin

Time frame: 14 days after administration of the first dose of metformin

Number of subjects who have at least one metformin concentration in blood measured at 1, 4 and 12 hours after an enteric dose

Pharmacokinetic analysis of metformin

Time frame: 14 days after administration of the first dose of metformin

Area under the curve of Plasma Concentration Versus Time (AUC) of metformin over a time frame of 1, 4 and 12 hours after an enteric dose of metformin.

Number of subjects who complete the treatment protocol

Time frame: 14 days after administration of the first dose of metformin

Number of subjects who complete the study doses of enteric metformin

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.