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

Last updated: August 1, 2024
Sponsor: Jena University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Birth Defects

Treatment

kidney function tests

cardiovacular examination

Questionnaire Reynolds Intellectual Assessment Scales and Screening

Clinical Study ID

NCT06534307
ZKSJ0133
  • Ages 6-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • mothers participation in one of the PETN studies

  • age above 5 years

  • completion of questionnaires for self reported data

  • written consent for physical examination

Exclusion Criteria - only physical examination:

  • physical and mental states preventing physical examination

Study Design

Total Participants: 228
Treatment Group(s): 12
Primary Treatment: kidney function tests
Phase:
Study Start date:
June 01, 2024
Estimated Completion Date:
March 31, 2028

Study Description

Pregnancies in which impaired uterine blood flow is detected by Doppler measurements during routine examinations in the second trimester are at high risk of developing fetal growth restriction (FGR). FGR affects 10% of pregnancies and is the leading cause of perinatal mortality and morbidity. In addition, intrauterine growth restriction places a lifelong burden on the physical and mental health of affected children. Epidemiological studies have shown that children with FGR have an increased risk of developing type 2 diabetes mellitus, hypertension, dyslipidemia and a high BMI. In addition, the affected children show disorders in hormonal balance and pubertal development as well as specific impairments of various cognitive and neurocognitive functions. There is also a link between FGR and lower cognitive ability in preschool children, school-age children and young adults, as well as lower communication, language and reading skills in school-age children. Neuronal development (e.g. EEG frequency spectra, resting-state networks) and executive functions are also impaired by FGR.

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.

Connect with a study center

  • Universitäts-Frauenklinik Tübingen

    Tübingen, Baden-Württemberg 72076
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm, Baden-Württemberg 89075
    Germany

    Site Not Available

  • Klinikum der Universität München

    München, Bayern 81377
    Germany

    Site Not Available

  • Städtisches Klinikum München

    München, Bayern 81545
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, Niedersachsen 30625
    Germany

    Site Not Available

  • Universitätsklinikum Bonn

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Site Not Available

  • Universitätsklinikum Dresden

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Uniklinikum Leipzig

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Krankenhaus St. Elisabeth und St. Barbara

    Halle, Sachsen-Anhalt 06110
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig Holstein

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Universitätsklinikum Jena

    Jena, Thüringen 07747
    Germany

    Active - Recruiting

  • Berlin Charité Campus Mitte

    Berlin, 10117
    Germany

    Site Not Available

  • Berlin Vivantes Klinikum Neukölln

    Berlin, 12351
    Germany

    Site Not Available

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