Long-term Follow-up of Children Born in the PETN Studies
- Conditions
- Intrauterine Growth RestrictionPentaerithrityl Teratnitrate in PregnancyLong-Term Effects to Children
- Registration Number
- NCT06534307
- Lead Sponsor
- Jena University Hospital
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 228
- mothers participation in one of the PETN studies
- age above 5 years
- completion of questionnaires for self reported data
- written consent for physical examination
Exclusion Criteria - only physical examination:
- physical and mental states preventing physical examination
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method childrens behaviour up to 2 years after study inclusion total score of either CBCL/16-18R or YSR/11-18R
- Secondary Outcome Measures
Name Time Method epigenetic analysis age of 6 to 8 years DNA-methylation
IQ development age of 6 to 8 years scores of RIAS test
physical development weight up to 2 years after study inclusion weight of the child in kg
age appropriate development up to 2 years after study inclusion age appropriate development documented as "yes or no" question in german routine examination plan ("Kinderuntersuchungsheft") in the last 6 years at caregivers
cardiovascular development age of 6 to 8 years pulse wave velosity
motoric development age of 6 to 8 years total score of M-ABC-2
symptoms of attention and activity disorders age of 6 to 8 years total scores of DISYPS-III
physical development height up to 2 years after study inclusion height of the child in cm
cognitive, motoric, and exectuve function up to 2 years after study inclusion scores of the eight domains of the FTF 5-15-R
physical development age above 10 years self reported tanner states
attention behaviour age of 6 to 8 years scores of the four domains of the cpt
neurocognitive development age of 6 to 8 years results of EEG power measurement in theta band
Trial Locations
- Locations (13)
Universitäts-Frauenklinik Tübingen
🇩🇪Tübingen, Baden-Württemberg, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Baden-Württemberg, Germany
Klinikum der Universität München
🇩🇪München, Bayern, Germany
Städtisches Klinikum München
🇩🇪München, Bayern, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Niedersachsen, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Krankenhaus St. Elisabeth und St. Barbara
🇩🇪Halle, Sachsen-Anhalt, Germany
Universitätsklinikum Dresden
🇩🇪Dresden, Sachsen, Germany
Uniklinikum Leipzig
🇩🇪Leipzig, Sachsen, Germany
Universitätsklinikum Schleswig Holstein
🇩🇪Kiel, Schleswig-Holstein, Germany
Scroll for more (3 remaining)Universitäts-Frauenklinik Tübingen🇩🇪Tübingen, Baden-Württemberg, Germany