Long-term Follow-up of Children Born in the PETN Studies

RecruitingOBSERVATIONAL
Enrollment

228

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2028

Conditions
Intrauterine Growth RestrictionPentaerithrityl Teratnitrate in PregnancyLong-Term Effects to Children
Interventions
BEHAVIORAL

Questionnaire Child Behaviour Checklist

The Child Behavior Checklist comprises items assigned to 8 subscales describing various behavioral areas. These subscales can be summed up to scores for internalizing and externalizing problems as well as a total score. Checklist scores are reported on a T-scale. Range of T-scale from scores 20 to 100 (average performance between scores 40 and 60). Higher scores mean higher amount of problems.

BEHAVIORAL

Questionnaire Young Self Report

The Questionnaire Young Self Report comprises items assigned to 8 subscales describing various behavioral areas. These subscales can be summed up to scores for internalizing and externalizing problems as well as a total score.

DIAGNOSTIC_TEST

physical examination

physical development examination including height (in cm), weight (in g) and tanner states

DIAGNOSTIC_TEST

metabolic examination

metabolic development using blood analysis including blood components, metabolic parameters (Glucose, HbA1c, cholestrol)

BEHAVIORAL

Questionnaire Reynolds Intellectual Assessment Scales and Screening

"The RIAS is standardized intelligence test. The RIAS provides an Total Intelligence Index (GIX, estimate of the general intelligence/g-factor), Verbal Intelligence Index (VIX) and the Nonverbal Intelligence Index (NIX). Test scores are reported on a T-scale. Range of T-scale from scores 20 to 100 (average performance between scores 40 and 60). Higher scores mean better cognitive performance."

DIAGNOSTIC_TEST

electroencephalogram

neurocognitive development

OTHER

Questionnaire Movement Assessment Battery for Children

"The M-ABC-2 is an standardized test to assess the motoric development. Adding up subscores addressing manual dexterity, aiming and catching, and balance delivers a total score of the motoric performance.~Test scores are reported on a T-scale. Range of T-scale from scores 20 to 100 (average performance between scores 40 and 60). Higher scores mean better performance."

OTHER

Questionnaire Continuous Performance Test

The CPT measures selective attention, sustained attention as well as impulsive behavior. Checklist scores are reported on a T-scale. Range of T-scale from scores 20 to 100 (average performance between scores 40 and 60). Higher scores mean worse performance.

OTHER

Questionnaire Diagnostic System for Mental Disorders

The FBB-ADHS assesses a total score for ADHD-like behavior and subscores for the symptom trias of ADHD (attention deficit, motoric hyperactivity as well as impulsive behavior, Questionnaire scores are reported on a T-scale. Range of T-scale from scores 20 to 100 (average performance between scores 40 and 60). Higher scores mean higher amount of symptoms.

DIAGNOSTIC_TEST

kidney function tests

urine examination (proteomics, cytokines, lipidomics)

OTHER

Questionnaire Five to Fifteen

The FTF 5-15R is a questionnaire to evaluate the child's developmental outcome in different areas of everyday life (cognition, language, and motor impairment as well as social, emotional, and behavioral problems). Individual item scores are added up per area and divided by the number of items. This results in a common scale value. Range of Percentile scores from 0 to 100 (0-90: no developmental problem; 90 and higher: hint for developmental problem). Higher scores mean worse developmental outcome.

DIAGNOSTIC_TEST

cardiovacular examination

measurement of pulse wave velocity

Trial Locations (13)

10117

NOT_YET_RECRUITING

Berlin Charité Campus Mitte, Berlin

12351

NOT_YET_RECRUITING

Berlin Vivantes Klinikum Neukölln, Berlin

24105

NOT_YET_RECRUITING

Universitätsklinikum Schleswig Holstein, Kiel

30625

NOT_YET_RECRUITING

Medizinische Hochschule Hannover, Hanover

53127

NOT_YET_RECRUITING

Universitätsklinikum Bonn, Bonn

72076

NOT_YET_RECRUITING

Universitäts-Frauenklinik Tübingen, Tübingen

81377

NOT_YET_RECRUITING

Klinikum der Universität München, München

81545

NOT_YET_RECRUITING

Städtisches Klinikum München, München

89075

NOT_YET_RECRUITING

Universitätsklinikum Ulm, Ulm

01307

NOT_YET_RECRUITING

Universitätsklinikum Dresden, Dresden

04103

NOT_YET_RECRUITING

Uniklinikum Leipzig, Leipzig

06110

NOT_YET_RECRUITING

Krankenhaus St. Elisabeth und St. Barbara, Halle

07747

RECRUITING

Universitätsklinikum Jena, Jena

All Listed Sponsors
lead

Jena University Hospital

OTHER