Long-term Follow-up of Children Born in the PETN Studies
NCT ID: NCT06534307
Last Updated: 2024-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
228 participants
OBSERVATIONAL
2024-06-01
2028-03-31
Brief Summary
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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.
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Detailed Description
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In the follow-up study, the children will be examined from the age of 6. Here, the effects of PETN on the development of children of women with high-risk pregnancies can be further investigated and a comparative study of growth-retarded and normal-growth children can also be carried out.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Placebo
children of mothers that have been taken placebos during participation of PETN study
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
PETN
children of mothers that have been taken in PETN during participation of PETN study
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age above 5 years
* completion of questionnaires for self reported data
* written consent for physical examination
Exclusion Criteria
6 Years
18 Years
ALL
No
Sponsors
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Jena University Hospital
OTHER
Responsible Party
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Tanja Groten
Deputy Head of Department of Obstetrics
Locations
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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
Countries
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Facility Contacts
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Karl O Kagan, Dr.
Role: primary
Harald Abele, Prof. Dr.
Role: backup
Ulrike Friebe-Hoffmann, PD Dr.
Role: primary
Christoph Hübener, Dr.
Role: primary
Laura de Vries, Dr.
Role: primary
Ninette Scharle
Role: backup
Constantin von Kaisenberg, Pr. Dr.
Role: primary
Matthias Jentschke, Dr.
Role: backup
Mateja Condic
Role: primary
Julia Welz
Role: backup
Matej Komar, Dr.
Role: primary
Jennifer L Winkler, Dr.
Role: backup
Anne Tauscher, Dr.
Role: primary
Susanne Schrey-Petersen, Dr.
Role: backup
Sven Seeger, Dr.
Role: primary
Yvonne Jäger, Dr.
Role: backup
Ulrich Pecks, PD Dr.
Role: primary
Christel Eckmann, Prof. Dr.
Role: backup
Ekkehard Schleußner, Prof. Dr.
Role: backup
Stefan Verlohren, PD Dr.
Role: primary
Wolfgang Schlembach, PD Dr.
Role: primary
Other Identifiers
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ZKSJ0133
Identifier Type: -
Identifier Source: org_study_id
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