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Trial · NCT06429007

A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury

NCT06429007, Phase 1, Enrolling by invitation, Boston Children's Hospital

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury. Trials, record NCT06429007. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06429007

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury
NCT number
NCT06429007
Status
Enrolling by invitation
Phases
Phase 1
Enrollment
30 participants, estimated
Lead sponsor
Boston Children's Hospital
Conditions
Hypoxic-Ischemic Encephalopathy, HIE, Neurodevelopment, Infant Development
Interventions
Metformin
First posted
2024-05-24
Last updated
2026-02-17

Source ClinicalTrials.gov

Registered outcomes4

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

ListOutcomeTime frameDescription
PrimarySafety profile of kidney function12 weeksA renal function panel (chem 10 with renal function) will be performed prior to the initiation of therapy and at all subsequent study visits.
PrimarySafety profile of liver function12 weeksA liver function test (LFT) will be performed prior to the initiation of therapy and at all subsequent study visits.
PrimaryRecruitment feasibility12 weeksTo assess feasibility, the number of eligible patients will be compared to the number of patients who consent to participate in the study.
SecondaryValidity of neonatal model of metformin pharmacokinetics12 weeksPlasma metformin levels will be analyzed by investigators with whole blood obtained at study visits.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
40850908DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06429007

GET https://conductscience.org/api/trials/v1/NCT06429007/registered