Long-term Follow-up of Children Born in the PETN Studies
NCT Number: NCT06534307
Acronym: LOOP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Intrauterine Growth Restriction|Pentaerithrityl Teratnitrate in Pregnancy|Long-Term Effects to Children
Interventions: BEHAVIORAL: Questionnaire Child Behaviour Checklist|BEHAVIORAL: Questionnaire Young Self Report|DIAGNOSTIC_TEST: physical examination|DIAGNOSTIC_TEST: metabolic examination|BEHAVIORAL: Questionnaire Reynolds Intellectual Assessment Scales and Screening|DIAGNOSTIC_TEST: electroencephalogram|OTHER: Questionnaire Movement Assessment Battery for Children|OTHER: Questionnaire Continuous Performance Test|OTHER: Questionnaire Diagnostic System for Mental Disorders|DIAGNOSTIC_TEST: kidney function tests|OTHER: Questionnaire Five to Fifteen|DIAGNOSTIC_TEST: cardiovacular examination
Sponsor: Jena University Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 228
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2028-03-31
Locations: Universitäts-Frauenklinik Tübingen, Tübingen, Baden-Württemberg, 72076, Germany|Universitätsklinikum Ulm, Ulm, Baden-Württemberg, 89075, Germany|Klinikum der Universität München, München, Bayern, 81377, Germany|Städtisches Klinikum München, München, Bayern, 81545, Germany|Medizinische Hochschule Hannover, Hannover, Niedersachsen, 30625, Germany|Universitätsklinikum Bonn, Bonn, Nordrhein-Westfalen, 53127, Germany|Krankenhaus St. Elisabeth und St. Barbara, Halle, Sachsen-Anhalt, 06110, Germany|Universitätsklinikum Dresden, Dresden, Sachsen, 01307, Germany|Uniklinikum Leipzig, Leipzig, Sachsen, 04103, Germany|Universitätsklinikum Schleswig Holstein, Kiel, Schleswig-Holstein, 24105, Germany|Universitätsklinikum Jena, Jena, Thüringen, 07747, Germany|Berlin Charité Campus Mitte, Berlin, 10117, Germany|Berlin Vivantes Klinikum Neukölln, Berlin, 12351, Germany

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.

Primary Outcome Measures: childrens behaviour, total score of either CBCL/16-18R or YSR/11-18R, up to 2 years after study inclusion
Secondary Outcome Measures: physical development height, height of the child in cm, up to 2 years after study inclusion|physical development weight, weight of the child in kg, up to 2 years after study inclusion|age appropriate development, age appropriate development documented as "yes or no" question in german routine examination plan ("Kinderuntersuchungsheft") in the last 6 years at caregivers, up to 2 years after study inclusion|cognitive, motoric, and exectuve function, scores of the eight domains of the FTF 5-15-R, up to 2 years after study inclusion|physical development, self reported tanner states, age above 10 years|cardiovascular development, pulse wave velosity, age of 6 to 8 years|IQ development, scores of RIAS test, age of 6 to 8 years|motoric development, total score of M-ABC-2, age of 6 to 8 years|attention behaviour, scores of the four domains of the cpt, age of 6 to 8 years|symptoms of attention and activity disorders, total scores of DISYPS-III, age of 6 to 8 years|neurocognitive development, results of EEG power measurement in alpha band, age of 6 to 8 years|neurocognitive development, results of EEG power measurement in beta band, age of 6 to 8 years|neurocognitive development, results of EEG power measurement in gamma band, age of 6 to 8 years|neurocognitive development, results of EEG power measurement in delta band, age of 6 to 8 years|neurocognitive development, results of EEG power measurement in theta band, age of 6 to 8 years|epigenetic analysis, DNA-methylation, age of 6 to 8 years