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Prematurity, Early Vascular Aging and Cardiorespiratory Fitness (PrEVAFit) – The impact of preterm birth and physical fitness on vascular health in children and adolescents.

Prematurity, Early Vascular Aging and Cardiorespiratory Fitness (PrEVAFit) – The impact of preterm birth and physical fitness on vascular health in children and adolescents. - PrEVAFit

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00039981
Enrollment
120
Registered
2026-04-27
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

P07.3

Interventions

Group 1: N=60 neonates, including n=50 preterm-born (gestational age =36+6 WoG, at least n=5 per week of gestation from 28+0 WoG
cross-sectional). Participants will undergo a single assessment at a corrected age of 40 weeks of gestation. Parental history and medical records will be reviewed for maternal conditions, causes of pr
cross-sectional). Participants will undergo a single assessment. Parental history and medical records will be reviewed for maternal conditions, causes of prematurity, and postnatal clinical course. Th

Sponsors

Klinik für Kardiologie und Angiologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 17 Years

Inclusion criteria

Inclusion criteria: Neonates: Informed consent from at least one parent / legal guardian. Adolescents: Age-appropriate information and consent from the child, as well as informed consent from at least one parent/legal guardian.

Exclusion criteria

Exclusion criteria: Neonates: Relevant anatomical malformations (especially cerebral, cardiac, and musculoskeletal); pulmonary hypertension; oxygen therapy; catecholamine-dependent circulatory depression; acute neurological disease (Grade IV intracranial hemorrhage, epilepsy); status post (S/P) severe necrotizing enterocolitis with intestinal resection. Adolescents: Status post oncological disease involving chemotherapy or radiotherapy; symptomatic congenital heart defect or one currently requiring treatment; cerebral palsy; epilepsy; chronic eye disease (glaucoma); disease-related limitation of maximal physical exertion (e.g., pulmonary hypertension, acute injuries, motor disorders, or relevant mobility restrictions); inability to follow specific instructions (e.g., documented severe cognitive impairment, psychiatric disorder); acute mental/psychiatric illness requiring pharmacological treatment (e.g., schizophrenia, depression).

Design outcomes

Primary

MeasureTime frame
Pre-post changes in the clinical and molecular vascular profile (composite score) following high-intensity aerobic exercise.

Secondary

MeasureTime frame
- Association of gestational age with the clinical and molecular vascular profile (composite score) in neonates and adolescents. - Comparison of extracellular vesicles in preterm-born versus term-born neonates. - Comparison of vascular inflammatory profile (cytokines) in preterm-born versus term-born neonates. - Comparison of epigenetic age (NeoAge Clock) in preterm-born versus term-born neonates. - Comparison of microbiomic profile in in preterm-born versus term-born neonates. - Comparison of vascular inflammatory profile (cytokines) in preterm-born versus term-born adolescents. - Comparison of epigenetic age (NeoAge Clock) in preterm-born versus term-born adolescents. - Comparison of the microbiomic profile in in preterm-born versus term-born adolescents. - Comparison of the proteomic profile in in preterm-born versus term-born adolescents. - Moderation of the association of FMD with gestational age by a composite lifestyle score, VO2peak and a cardiovascular risk score (BMI, blood pressure, HbA1c, lipid profile, triglycerides) in adolescents. - Moderation of the association of baPWV with gestational age by a composite lifestyle score, VO2peak and a cardiovascular risk score (BMI, blood pressure, HbA1c, lipid profile, triglycerides) in adolescents. - Moderation of the association of SVA (AVR, arteriolar diameter, venular diameter) with gestational age by a composite lifestyle score, VO2peak and a cardiovascular risk score (BMI, blood pressure, HbA1c, lipid profile, triglycerides) in adolescents. - Moderation of the association of cIMT with gestational age by a composite lifestyle score, VO2peak and a cardiovascular risk score (BMI, blood pressure, HbA1c, lipid profile, triglycerides) in adolescents.

Countries

Germany

Contacts

Public ContactKarsten Königstein

Universitätskinderklinik

karsten.koenigstein@med.ovgu.de+49 391 67 24865

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026