Long-term follow-up of children born to mothers with pregnancy complications
Official title: Langzeiteffekt Einer Pentaerithrityltetranitrat (PETN)-Behandlung in Der Schwangerschaft - Nachbeobachtung Der Kinder Der PETN-Studien
Run by Jena University Hospital · NCT06534307 · Data updated 2026-11-12
This study looks at how children born to mothers with pregnancy complications, like restricted growth due to poor blood flow, develop over time to see if their health and behavior differ from those born without these issues.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Years to 18 Years |
| Sex | All |
| Enrollment | 228 (estimated) |
| Sponsor | Jena University Hospital Academic / other |
| Locations | 13 sites (Tübingen, Baden-Wurttemberg and 12 other locations) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2028 |
| Registry record updated | August 2, 2024 |
| Trial ID | NCT06534307 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 6 years and older who were born to mothers who participated in the PETN studies.
✕Probably not a fit
Patients who do not meet the inclusion criteria or have physical and mental conditions that prevent participation in physical examinations may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the long-term effects on children born from pregnancies affected by intrauterine growth restriction (IUGR) due to impaired placental blood flow. It follows children from previous studies where mothers were treated with Pentaerithrityl Teratnitrate (PETN) or placebo. The study will evaluate various aspects of child development, including physical health, cognitive abilities, and behavioral outcomes, starting from the age of 6. Data will be collected through questionnaires, physical examinations, and metabolic assessments to compare growth-retarded children with those who had normal growth.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term health and developmental needs of children born from high-risk pregnancies, potentially guiding future interventions.
How similar studies have gone: Other studies have shown significant associations between intrauterine growth restriction and long-term health outcomes, indicating that this follow-up approach is built on established findings.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Universitätsklinikum Jena
Jena, Thuringia, Germany Recruiting -
Universitäts-Frauenklinik Tübingen
Tübingen, Baden-Wurttemberg, Germany Not yet recruiting -
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany Not yet recruiting -
Klinikum der Universität München
München, Bavaria, Germany Not yet recruiting -
Städtisches Klinikum München
München, Bavaria, Germany Not yet recruiting -
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany Not yet recruiting
Show 7 more locations
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Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany Not yet recruiting -
Universitätsklinikum Dresden
Dresden, Saxony, Germany Not yet recruiting -
Uniklinikum Leipzig
Leipzig, Saxony, Germany Not yet recruiting -
Krankenhaus St. Elisabeth und St. Barbara
Halle, Saxony-Anhalt, Germany Not yet recruiting -
Universitätsklinikum Schleswig Holstein
Kiel, Schleswig-Holstein, Germany Not yet recruiting -
Berlin Charité Campus Mitte
Berlin, Germany Not yet recruiting -
Berlin Vivantes Klinikum Neukölln
Berlin, Germany Not yet recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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-
Understanding how nutrition affects growth in premature infants
This study looks at how the food that premature babies eat in the NICU affects their growth and development over three years.
-
Identifying Women at Risk for Placental Dysfunction
This study is trying to see if a new tool can help identify pregnant women at risk for placental problems by looking at their health information and blood tests.
-
Investigating cardiovascular risks in women after complicated pregnancies
This study looks at how having high blood pressure during pregnancy might affect women's heart health later on and whether certain blood tests can help predict their risk for heart problems.
-
Maternal supplementation to improve fetal brain development in growth-restricted pregnancies
This study is testing if giving pregnant women supplements to help their babies' brain development can improve outcomes for babies who are not growing well in the womb.
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Screening and planned delivery to prevent preeclampsia at term
This study is testing a new blood test to see if it can help predict preeclampsia in first-time pregnant women and if inducing labor early can lower the chances of complications for both mom and baby.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.