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QTc Intervals in Former Preterm/Extreme Low Birth Weight Infants: a Pooled Study Proposal

NCT05243537 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2023-05-18

No results posted yet for this study

Summary

Pooling effort to collect previously reported data on QTc time in former preterm neonates, and compare these data to controls. At present and based on a recently conducted systematic search, there are conflicting data on the potential QT interval prolongation (all Bazett) in former extreme low birth weight (ELBW, \<1000 g) infants or preterms.

Consequently, if investigators truly want to assess the presence or absence of either a difference or a prolongation of QTc intervals in this specific population, pooling of published data is likely the most effective approach (potential number of cases = 24 + 49 + 93 = 166; potential number of controls in the same studies = 24 + 53 + 87 = 164), preferably based on individual data.

Although the sample is to a large extent pragmatic (as available), the investigators hereby aim to target the 5 ms QTc prolongation applied by the authorities (FDA, EMA) in paired healthy adult volunteer studies as 'golden' standard as primary outcome variable \[EMA guideline, FDA guidance\].

Conditions

Interventions

OTHER

ECG (diagnostic)

ECG collection (once, at rest), in both cases and controls

Sponsors & Collaborators

  • St. Justine's Hospital

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • karel allegaert, MD, PhD · UZ Leuven

Eligibility

Min Age
8 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-04-01
Completion
2023-11-01

Countries

  • Belgium
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05243537 on ClinicalTrials.gov