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Long-term Follow-up of Children Born in the PETN Studies
Sponsor: Jena University Hospital
Summary
In every 10th pregnancy, the child in the uterus is insufficiently nourished, a so-called growth retardation. This occurs when the child cannot reach its growth potential due to an undersupply in the uterus. This inadequate supply is considered a developmental cause for the later development of physical diseases like cardiovascular diseases, sugar metabolism disorders and obesity as well as mental developmental problems (for example problems in cognitive skills, deficits in language development, concentration and attention). From 2002 to 2008, 111 patients with impaired placental blood flow were included in a small study and treated with Pentalong or placebo. From 2017 to 2022, the positive effects of the study treatment were tested on a larger number of patients. A total of 317 pregnant women were included at 14 participating study centers in Germany. In this follow-up study, the development of the children born in the two studies will be examined. The study consists of two independent parts: firstly, questionnaires are answered by the former participants and secondly, an on-site visit is carried out to check the physical and mental health of the child.
Official title: Langzeiteffekt Einer Pentaerithrityltetranitrat (PETN)-Behandlung in Der Schwangerschaft - Nachbeobachtung Der Kinder Der PETN-Studien
Key Details
Gender
All
Age Range
6 Years - 18 Years
Study Type
OBSERVATIONAL
Enrollment
228
Start Date
2024-06-01
Completion Date
2028-03-31
Last Updated
2024-08-02
Healthy Volunteers
No
Conditions
Interventions
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.
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.
physical examination
physical development examination including height (in cm), weight (in g) and tanner states
metabolic examination
metabolic development using blood analysis including blood components, metabolic parameters (Glucose, HbA1c, cholestrol)
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.
electroencephalogram
neurocognitive development
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.
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.
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.
kidney function tests
urine examination (proteomics, cytokines, lipidomics)
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.
cardiovacular examination
measurement of pulse wave velocity
Locations (13)
Universitäts-Frauenklinik Tübingen
Tübingen, Baden-Wurttemberg, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Klinikum der Universität München
München, Bavaria, Germany
Städtisches Klinikum München
München, Bavaria, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Universitätsklinikum Dresden
Dresden, Saxony, Germany
Uniklinikum Leipzig
Leipzig, Saxony, Germany
Krankenhaus St. Elisabeth und St. Barbara
Halle, Saxony-Anhalt, Germany
Universitätsklinikum Schleswig Holstein
Kiel, Schleswig-Holstein, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Berlin Charité Campus Mitte
Berlin, Germany
Berlin Vivantes Klinikum Neukölln
Berlin, Germany