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

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.

Conditions

• Intrauterine Growth Restriction
• Pentaerithrityl Teratnitrate in Pregnancy
• Long-Term Effects to Children

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

DIAGNOSTIC_TEST

physical examination

physical development examination including height (in cm), weight (in g) and tanner states

DIAGNOSTIC_TEST

metabolic examination

metabolic development using blood analysis including blood components, metabolic parameters (Glucose, HbA1c, cholestrol)

BEHAVIORAL

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.

DIAGNOSTIC_TEST

electroencephalogram

neurocognitive development

OTHER

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.

OTHER

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.

OTHER

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.

DIAGNOSTIC_TEST

kidney function tests

urine examination (proteomics, cytokines, lipidomics)

OTHER

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.

DIAGNOSTIC_TEST

cardiovacular examination

measurement of pulse wave velocity

Sponsors & Collaborators

• Jena University Hospital

  lead OTHER

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-01

Primary Completion

2027-03-31

Completion

2028-03-31

Countries

• Germany

Study Locations