Long-term follow-up of children born in the PETN studies

Long-term follow-up of children born in the PETN studies - LOOP

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00033628

Enrollment

228

Registered

2024-03-04

Start date

2024-05-29

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

P05

Interventions

Group 1: The children of mothers with high-risk pregnancies who were treated with PETN or placebo during pregnancy are invited to participate in a two-stage assessment of physical and (neuro)cognitive

optional: stool sample to record epigenetic changes 2. On-site visit at the study center (basic visit) for children of the PETN multicenter study (approx. 3h): Clinical examination at the study cente

Eligibility

Sex/Gender

All

Age

6 Years to No maximum

Inclusion criteria

Inclusion criteria: Participation in the study: - Participation of the mother in one of the PETN studies during pregnancy with the participating child - Age of the child: = 6 years - Presence of completed questionnaires (will be considered as consent of a custodial person/adult child to participate) Use of the stool sample: - Presence of written consent from a person with custody On-site examination of a PETN multicenter study child: - Written consent of a person with custody to be contacted - Availability of the completed questionnaires - written consent of a person with custody after verbal explanation before the start of the examinations - if possible and desired: written consent of the child after age-appropriate verbal information before the start of the examinations

Exclusion criteria

Exclusion criteria: For on-site visit: mental and physical conditions that hinder appropriate test performance

Design outcomes

Primary

Measure	Time frame
Total test score of the parent questionnaire on the behavior of children and adolescents (CBCL/6-18R or YSR/11-18R)	—

Secondary

Measure	Time frame
- Weight and height (reported) - General development results (age-appropriate development according to the U-examination and FTF 5-15-R questionnaire) - cognitive, motor and executive functions (scores of the 8 domains of the FTF 5-15-R) - socio-economic status	—

Countries

Germany

Contacts

Public ContactTanja Groten

Klinik für Geburtsmedizin

LOOP@med.uni-jena.de0049 3641 93 90 523

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026