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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Primary outcome measure(s)

• childrens behaviour — up to 2 years after study inclusion
  total score of either CBCL/16-18R or YSR/11-18R

Trial sites (13)

More Jena University Hospital trials in Germany