NCT Number: NCT06534307
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.
Interested in participating?
Request Info6 year–18 year
All sexes
Observational
Universitäts-Frauenklinik Tübingen, Tübingen, Baden-Wurttemberg, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
- only physical examination:
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.
Other names: CBCL/6-18R
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.
Other names: YSR/11-18R
physical development examination including height (in cm), weight (in g) and tanner states
metabolic development using blood analysis including blood components, metabolic parameters (Glucose, HbA1c, cholestrol)
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.
Other names: RIAS
neurocognitive development
Other names: EEG
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 names: M-ABC-2
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 names: CPT
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.
Other names: FBB-ADHS
urine examination (proteomics, cytokines, lipidomics)
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.
Other names: FTF 5-15R
measurement of pulse wave velocity
Other names: Arteriograph
Time frame: up to 2 years after study inclusion
total score of either CBCL/16-18R or YSR/11-18R
Time frame: up to 2 years after study inclusion
height of the child in cm
Time frame: up to 2 years after study inclusion
weight of the child in kg
Time frame: 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
Time frame: up to 2 years after study inclusion
scores of the eight domains of the FTF 5-15-R
Time frame: age above 10 years
self reported tanner states
Time frame: age of 6 to 8 years
pulse wave velosity
Time frame: age of 6 to 8 years
scores of RIAS test
Time frame: age of 6 to 8 years
total score of M-ABC-2
Time frame: age of 6 to 8 years
scores of the four domains of the cpt
Time frame: age of 6 to 8 years
total scores of DISYPS-III
Time frame: age of 6 to 8 years
results of EEG power measurement in alpha band
Time frame: age of 6 to 8 years
results of EEG power measurement in beta band
Time frame: age of 6 to 8 years
results of EEG power measurement in gamma band
Time frame: age of 6 to 8 years
results of EEG power measurement in delta band
Time frame: age of 6 to 8 years
results of EEG power measurement in theta band
Time frame: age of 6 to 8 years
DNA-methylation
Jena University Hospital
Other
Langzeiteffekt Einer Pentaerithrityltetranitrat (PETN)-Behandlung in Der Schwangerschaft - Nachbeobachtung Der Kinder Der PETN-Studien
Acronym: LOOP
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