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

NCT05243537 | Unknown

• 1 other identifier: S66020
• Study Type: observational
• Target: 250
• Locations: 2 countries
• Sites: 2

Brief 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

Qt Interval; Preterm Birth

Keywords

QTc; ELBW neonates; preterms; pharmacovigilance

Outcome Measures

Primary Outcomes (1)

• QTc time interval

  QTc time interval (in msec) in former preterms or healthy term controls

  1 year

Study Arms (1)

QTc time interval in former preterm neonates, or term born healthy controls

former preterms and healthy term controls are defined as described in the cohort as previously published (Salaets et al, Pediatr Res 2021; Gervais et al, Pediatr Res 2020; Bassareo et al, J Matern Fetal Neonatal Med 2011). This includes both the perinatal characteristics as well as the characteristics collected at assessment (pediatric age or young adulthood) In all cases, an ECG was collected at rest, and these individual values (preterm or healthy term controls will be pooled.

Other: ECG (diagnostic)

Interventions

ECG (diagnostic) OTHER

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

QTc time interval in former preterm neonates, or term born healthy controls

Eligibility Criteria

• Age: 8 Years - 25 Years
• Gender Eligibility Details: QTc interval is known to be different between both genders
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The Bassareo cohort, Gervais cohort and Salaets cohort have been described in the original papers. we intent to pool the individual data of these cohorts (all these cohorts were constructed based on probability sampling) Bassareo, P. P. et al. Significant QT interval prolongation and long QT in young adult ex-preterm newborns with extremely low birth weight. J. Matern. Fetal Neonatal Med. 24, 1115-1118 (2011). Gervais, A. S. et al. Electrocardiographic features at rest and during exercise in young adults born preterm below 30 weeks of gestation. Pediatr. Res. 88, 305-311 (2020). Salaets, T. QTc intervals are not prolonged in former ELBW infants at pre-adolescent age. Pediatr. Res. 2021, online.

You may qualify if:

• included as 'case' in one of the cohorts retrieved by a systematic search on QTc values in former preterm neonates compared to healthy controls, or.
• included a 'control' in one of the cohorts retrieved by a systematic search on QTc values in former preterm neonates compared to healthy controls.

You may not qualify if:

• not included as 'case' in any of the cohorts retrieved by systematic search on QTc values in former preterm neonates compared to healthy controls
• not included as 'control' in any of the cohorts retrieved by systematic search on QTc values in former preterm neonates compared to healthy controls

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• St. Justine's Hospital: collaborator

Study Sites (2)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitair Sainte-Justine

Montreal, Quebec, Canada

Location

Related Publications (4)

• Gervais AS, Flahault A, Chan T, Bastien-Tardif C, Al-Simaani A, Cloutier A, Luu TM, Abadir S, Nuyt AM. Electrocardiographic features at rest and during exercise in young adults born preterm below 30 weeks of gestation. Pediatr Res. 2020 Aug;88(2):305-311. doi: 10.1038/s41390-020-0814-9. Epub 2020 Mar 2.

  PMID: 32120379 BACKGROUND

• Bassareo PP, Fanos V, Puddu M, Cadeddu C, Balzarini M, Mercuro G. Significant QT interval prolongation and long QT in young adult ex-preterm newborns with extremely low birth weight. J Matern Fetal Neonatal Med. 2011 Sep;24(9):1115-8. doi: 10.3109/14767058.2010.543600. Epub 2011 Jan 10.

  PMID: 21219107 BACKGROUND

• Salaets T, Raaijmakers A, Zhang ZY, Yu YL, Wei DM, Staessen JA, Allegaert K. QTc intervals are not prolonged in former ELBW infants at pre-adolescent age. Pediatr Res. 2022 Sep;92(3):848-852. doi: 10.1038/s41390-021-01877-w. Epub 2021 Dec 2.

  PMID: 34857877 RESULT

• Vanthienen J, Petrov MV, Luu TM, Cloutier A, Raaijmakers A, Staessen JA, Zhang Z, Salaets T, Laenen A, Smits A, Nuyt AM, Flahault A, Allegaert K. The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls. Drug Saf. 2023 Sep;46(9):897-904. doi: 10.1007/s40264-023-01335-y. Epub 2023 Jul 28.

  PMID: 37505401 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

epicatechin gallate

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• karel allegaert, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 17, 2022
• Study Start: January 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: November 1, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Locations

CA (1); BE (1)