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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.
Pregnancies in which impaired uterine blood flow is detected by Doppler measurements during routine examinations in the second trimester are at high risk of developing fetal growth restriction (FGR). FGR affects 10% of pregnancies and is the leading cause of perinatal mortality and morbidity. In addition, intrauterine growth restriction places a lifelong burden on the physical and mental health of affected children. Epidemiological studies have shown that children with FGR have an increased risk of developing type 2 diabetes mellitus, hypertension, dyslipidemia and a high BMI. In addition, the affected children show disorders in hormonal balance and pubertal development as well as specific impairments of various cognitive and neurocognitive functions. There is also a link between FGR and lower cognitive ability in preschool children, school-age children and young adults, as well as lower communication, language and reading skills in school-age children. Neuronal development (e.g. EEG frequency spectra, resting-state networks) and executive functions are also impaired by FGR.
In the follow-up study, the children will be examined from the age of 6. Here, the effects of PETN on the development of children of women with high-risk pregnancies can be further investigated and a comparative study of growth-retarded and normal-growth children can also be carried out.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | children of mothers that have been taken placebos during participation of PETN study |
| |
| PETN | children of mothers that have been taken in PETN during participation of PETN study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| childrens behaviour | total score of either CBCL/16-18R or YSR/11-18R | up to 2 years after study inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| physical development height | height of the child in cm | up to 2 years after study inclusion |
| physical development weight | weight of the child in kg |
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Inclusion Criteria:
Exclusion Criteria - only physical examination:
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all live born children from participants of the PETN-studies
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäts-Frauenklinik Tübingen | Not yet recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
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DNA-methylation and gene expression
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| 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. |
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| physical examination | Diagnostic Test | physical development examination including height (in cm), weight (in g) and tanner states |
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| metabolic examination | Diagnostic Test | metabolic development using blood analysis including blood components, metabolic parameters (Glucose, HbA1c, cholestrol) |
|
| 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. |
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| electroencephalogram | Diagnostic Test | neurocognitive development |
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| 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. |
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| 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. |
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| 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. |
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| kidney function tests | Diagnostic Test | urine examination (proteomics, cytokines, lipidomics) |
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| 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. |
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| cardiovacular examination | Diagnostic Test | measurement of pulse wave velocity |
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| up to 2 years after study inclusion |
| age appropriate development | age appropriate development documented as "yes or no" question in german routine examination plan ("Kinderuntersuchungsheft") in the last 6 years at caregivers | up to 2 years after study inclusion |
| cognitive, motoric, and exectuve function | scores of the eight domains of the FTF 5-15-R | up to 2 years after study inclusion |
| physical development | self reported tanner states | age above 10 years |
| cardiovascular development | pulse wave velosity | age of 6 to 8 years |
| IQ development | scores of RIAS test | age of 6 to 8 years |
| motoric development | total score of M-ABC-2 | age of 6 to 8 years |
| attention behaviour | scores of the four domains of the cpt | age of 6 to 8 years |
| symptoms of attention and activity disorders | total scores of DISYPS-III | age of 6 to 8 years |
| neurocognitive development | results of EEG power measurement in alpha band | age of 6 to 8 years |
| neurocognitive development | results of EEG power measurement in beta band | age of 6 to 8 years |
| neurocognitive development | results of EEG power measurement in gamma band | age of 6 to 8 years |
| neurocognitive development | results of EEG power measurement in delta band | age of 6 to 8 years |
| neurocognitive development | results of EEG power measurement in theta band | age of 6 to 8 years |
| epigenetic analysis | DNA-methylation | age of 6 to 8 years |
| Universitätsklinikum Ulm | Not yet recruiting | Ulm | Baden-Wurttemberg | 89075 | Germany |
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| Klinikum der Universität München | Not yet recruiting | München | Bavaria | 81377 | Germany |
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| Städtisches Klinikum München | Not yet recruiting | München | Bavaria | 81545 | Germany |
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| Medizinische Hochschule Hannover | Not yet recruiting | Hanover | Lower Saxony | 30625 | Germany |
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| Universitätsklinikum Bonn | Not yet recruiting | Bonn | North Rhine-Westphalia | 53127 | Germany |
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| Universitätsklinikum Dresden | Not yet recruiting | Dresden | Saxony | 01307 | Germany |
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| Uniklinikum Leipzig | Not yet recruiting | Leipzig | Saxony | 04103 | Germany |
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| Krankenhaus St. Elisabeth und St. Barbara | Not yet recruiting | Halle | Saxony-Anhalt | 06110 | Germany |
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| Universitätsklinikum Schleswig Holstein | Not yet recruiting | Kiel | Schleswig-Holstein | 24105 | Germany |
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| Universitätsklinikum Jena | Recruiting | Jena | Thuringia | 07747 | Germany |
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| Berlin Charité Campus Mitte | Not yet recruiting | Berlin | 10117 | Germany |
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| Berlin Vivantes Klinikum Neukölln | Not yet recruiting | Berlin | 12351 | Germany |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D008403 | Mass Screening |
| D004569 | Electroencephalography |
| C412459 | ABCB10 protein, human |
| C000708228 | 2-cyclohexylidenhydrazo-4-phenyl-thiazole |
| D007677 | Kidney Function Tests |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |
| D003943 | Diagnostic Techniques, Neurological |
| D004568 | Electrodiagnosis |
| D003950 | Diagnostic Techniques, Urological |
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