Clinical trial NCT06534307: Long-term Follow-up of Children Born in the PETN Studies
Official title: Langzeiteffekt Einer Pentaerithrityltetranitrat (PETN)-Behandlung in Der Schwangerschaft - Nachbeobachtung Der Kinder Der PETN-Studien
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intrauterine Growth Restriction
Pentaerithrityl Teratnitrate in Pregnancy
Long-Term Effects to Children
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 228
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all live born children from participants of the PETN-studies

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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: childrens behaviour
timeFrame: up to 2 years after study inclusion
Secondary outcomes:
measure: physical development height
timeFrame: up to 2 years after study inclusion
measure: physical development weight
timeFrame: up to 2 years after study inclusion
measure: age appropriate development
timeFrame: up to 2 years after study inclusion
measure: cognitive, motoric, and exectuve function
timeFrame: up to 2 years after study inclusion
measure: physical development
timeFrame: age above 10 years
measure: cardiovascular development
timeFrame: age of 6 to 8 years
measure: IQ development
timeFrame: age of 6 to 8 years
measure: motoric development
timeFrame: age of 6 to 8 years
measure: attention behaviour
timeFrame: age of 6 to 8 years
measure: symptoms of attention and activity disorders
timeFrame: age of 6 to 8 years
measure: neurocognitive development
timeFrame: age of 6 to 8 years
measure: neurocognitive development
timeFrame: age of 6 to 8 years
measure: neurocognitive development
timeFrame: age of 6 to 8 years
measure: neurocognitive development
timeFrame: age of 6 to 8 years
measure: neurocognitive development
timeFrame: age of 6 to 8 years
measure: epigenetic analysis
timeFrame: age of 6 to 8 years
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Universitäts-Frauenklinik Tübingen
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-Württemberg
city: München
country: Germany
facility: Klinikum der Universität München
state: Bayern
city: München
country: Germany
facility: Städtisches Klinikum München
state: Bayern
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: Nordrhein-Westfalen
city: Halle
country: Germany
facility: Krankenhaus St. Elisabeth und St. Barbara
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
state: Sachsen
city: Leipzig
country: Germany
facility: Uniklinikum Leipzig
state: Sachsen
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig Holstein
state: Schleswig-Holstein
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thüringen
city: Berlin
country: Germany
facility: Berlin Charité Campus Mitte
city: Berlin
country: Germany
facility: Berlin Vivantes Klinikum Neukölln
Study officials:
References: