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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorJena University Hospital

About this trial

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

Qualifiers

mothers participation in one of the PETN studies

age above 5 years

completion of questionnaires for self reported data

written consent for physical examination

Disqualifiers

physical and mental states preventing physical examination

Trial design

Treatments tested in this trial

  • Questionnaire Child Behaviour Checklist
  • Questionnaire Young Self Report
  • physical examination
  • metabolic examination
  • Questionnaire Reynolds Intellectual Assessment Scales and Screening
  • electroencephalogram
  • Questionnaire Movement Assessment Battery for Children
  • Questionnaire Continuous Performance Test
  • Questionnaire Diagnostic System for Mental Disorders
  • kidney function tests
  • Questionnaire Five to Fifteen
  • cardiovacular examination

Treatment groups

228 Participants
are divided into 2 treatment groups

Sponsors and collaborators