Actively Recruiting

Age: 6Years - 18Years
All Genders
NCT06534307

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

Led by Jena University Hospital · Updated on 2024-08-02

228

Participants Needed

13

Research Sites

199 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Mother participated in one of the PETN studies
  • Child is older than 5 years
  • Completion of questionnaires for self-reported data
  • Written consent provided for physical examination
Not Eligible

You will not qualify if you...

  • Physical or mental conditions preventing physical examination

AI-Screening

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Trial Site Locations

Total: 13 locations

1

Universitäts-Frauenklinik Tübingen

Tübingen, Baden-Wurttemberg, Germany, 72076

Not Yet Recruiting

2

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany, 89075

Not Yet Recruiting

3

Klinikum der Universität München

München, Bavaria, Germany, 81377

Not Yet Recruiting

4

Städtisches Klinikum München

München, Bavaria, Germany, 81545

Not Yet Recruiting

5

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany, 30625

Not Yet Recruiting

6

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany, 53127

Not Yet Recruiting

7

Universitätsklinikum Dresden

Dresden, Saxony, Germany, 01307

Not Yet Recruiting

8

Uniklinikum Leipzig

Leipzig, Saxony, Germany, 04103

Not Yet Recruiting

9

Krankenhaus St. Elisabeth und St. Barbara

Halle, Saxony-Anhalt, Germany, 06110

Not Yet Recruiting

10

Universitätsklinikum Schleswig Holstein

Kiel, Schleswig-Holstein, Germany, 24105

Not Yet Recruiting

11

Universitätsklinikum Jena

Jena, Thuringia, Germany, 07747

Actively Recruiting

12

Berlin Charité Campus Mitte

Berlin, Germany, 10117

Not Yet Recruiting

13

Berlin Vivantes Klinikum Neukölln

Berlin, Germany, 12351

Not Yet Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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