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Trial · NCT07120971

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of participants who tolerate metformin14 days after administration of the first dose of metforminNumber of subjects who receive enteral doses of metformin and complete the study days without an adverse event while continuing enteral feedings
PrimaryNumber of participants with treatment-related adverse events14 days after administration of the first dose of metforminNumber of participants who develop hypoglycemia defined as blood glucose value \<50
PrimaryNumber of participants with treatment-related metabolic acidosis14 days after administration of the first dose of metforminNumber of subjects who develop lactic acid levels \> 5mmol/L
PrimaryNumber of subjects with treatment-related feeding problems14 days after administration of the first dose of metforminNumber of subjects who require a decrease in enteral feeding volume by \>50% from baseline
PrimaryNumber of subjects who require dose adjustments of metformin14 days after administration of the first dose of metforminNumber of subjects who need decreases in dose or discontinuation of metformin due to hepatic or renal dysfunction
PrimaryNumber of subjects with respiratory deterioration14 days after administration of the first dose of metforminNumber of subjects who develop pneumonia and increases in oxygen concentration and ventilator support during the study
PrimaryNumber of subjects who complete pharmacokinetic evaluation of metformin14 days after administration of the first dose of metforminNumber of subjects who have at least one metformin concentration in blood measured at 1, 4 and 12 hours after an enteric dose
PrimaryPharmacokinetic analysis of metformin14 days after administration of the first dose of metforminArea 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.
PrimaryNumber of subjects who complete the treatment protocol14 days after administration of the first dose of metforminNumber of subjects who complete the study doses of enteric metformin
SecondaryIncidence of bronchopulmonary dysplasia14 days after administration of the first dose of metforminNumber of subjects who are diagnosed with bronchopulmonary dysplasia
SecondaryIncidence of necrotizing enterocolitis14 days after administration of the first dose of metforminNumber of subjects who are diagnosed with necrotizing enterocolitis
SecondaryIncidence of retinopathy of prematurity14 days after administration of the first dose of metforminNumber of subjects who are diagnosed with retinopathy of prematurity
SecondaryIncidence of intraventricular hemorrhage14 days after administration of the first dose of metforminNumber of subjects who are diagnosed with intraventricular hemorrhage
SecondaryIncidence of patent ductus arteriosus14 days after administration of the first dose of metforminNumber of subjects who are diagnosed with patent ductus arteriosus

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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