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

NCT06534307 | Recruiting

• 1 other identifier: ZKSJ0133
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 13

Brief 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

Outcome Measures

Primary Outcomes (1)

• childrens behaviour

  total score of either CBCL/16-18R or YSR/11-18R

  up to 2 years after study inclusion

Secondary Outcomes (16)

• physical development height

  up to 2 years after study inclusion

• physical development weight

  up to 2 years after study inclusion

• age appropriate development

  up to 2 years after study inclusion

• cognitive, motoric, and exectuve function

  up to 2 years after study inclusion

• physical development

  age above 10 years

Study Arms (2)

Placebo

children of mothers that have been taken placebos during participation of PETN study

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

PETN

children of mothers that have been taken in PETN during participation of PETN study

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

Interventions

Questionnaire Child Behaviour Checklist BEHAVIORAL

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.

Also known as: CBCL/6-18R

PETN; Placebo

Questionnaire Young Self Report BEHAVIORAL

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.

Also known as: YSR/11-18R

PETN; Placebo

physical examination DIAGNOSTIC_TEST

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

PETN; Placebo

metabolic examination DIAGNOSTIC_TEST

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

PETN; Placebo

Questionnaire Reynolds Intellectual Assessment Scales and Screening BEHAVIORAL

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.

Also known as: RIAS

PETN; Placebo

electroencephalogram DIAGNOSTIC_TEST

neurocognitive development

Also known as: EEG

PETN; Placebo

Questionnaire Movement Assessment Battery for Children OTHER

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.

Also known as: M-ABC-2

PETN; Placebo

Questionnaire Continuous Performance Test OTHER

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.

Also known as: CPT

PETN; Placebo

Questionnaire Diagnostic System for Mental Disorders OTHER

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.

Also known as: FBB-ADHS

PETN; Placebo

kidney function tests DIAGNOSTIC_TEST

urine examination (proteomics, cytokines, lipidomics)

PETN; Placebo

Questionnaire Five to Fifteen OTHER

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.

Also known as: FTF 5-15R

PETN; Placebo

cardiovacular examination DIAGNOSTIC_TEST

measurement of pulse wave velocity

Also known as: Arteriograph

PETN; Placebo

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

all live born children from participants of the PETN-studies

You may qualify if:

• mothers participation in one of the PETN studies
• age above 5 years
• completion of questionnaires for self reported data
• written consent for physical examination

You may not qualify if:

• physical and mental states preventing physical examination

Sponsors & Collaborators

• Jena University Hospital: lead

Study Sites (13)

Universitäts-Frauenklinik Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

NOT YET RECRUITING

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89075, Germany

NOT YET RECRUITING

Klinikum der Universität München

München, Bavaria, 81377, Germany

NOT YET RECRUITING

Städtisches Klinikum München

München, Bavaria, 81545, Germany

NOT YET RECRUITING

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

NOT YET RECRUITING

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

NOT YET RECRUITING

Universitätsklinikum Dresden

Dresden, Saxony, 01307, Germany

NOT YET RECRUITING

Uniklinikum Leipzig

Leipzig, Saxony, 04103, Germany

NOT YET RECRUITING

Krankenhaus St. Elisabeth und St. Barbara

Halle, Saxony-Anhalt, 06110, Germany

NOT YET RECRUITING

Universitätsklinikum Schleswig Holstein

Kiel, Schleswig-Holstein, 24105, Germany

NOT YET RECRUITING

Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

RECRUITING

Berlin Charité Campus Mitte

Berlin, 10117, Germany

NOT YET RECRUITING

Berlin Vivantes Klinikum Neukölln

Berlin, 12351, Germany

NOT YET RECRUITING

Biospecimen

Retention: NONE RETAINED

DNA-methylation and gene expression

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Physical Examination; Mass Screening; Electroencephalography; ABCB10 protein, human; 2-cyclohexylidenhydrazo-4-phenyl-thiazole; Kidney Function Tests

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Diagnostic Techniques, Neurological; Electrodiagnosis; Diagnostic Techniques, Urological

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head of Department of Obstetrics

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: August 2, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (13)