Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534307
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-14
Brief Title:
Long-term Follow-up of Children Born in the PETN Studies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Langzeiteffekt Einer Pentaerithrityltetranitrat PETN-Behandlung in Der Schwangerschaft - Nachbeobachtung Der Kinder Der PETN-Studien
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOOP
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
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 eg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None