Long-term follow-up of children born to mothers with pregnancy complications
Langzeiteffekt Einer Pentaerithrityltetranitrat (PETN)-Behandlung in Der Schwangerschaft - Nachbeobachtung Der Kinder Der PETN-Studien
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 |
|---|---|
| Enrollment | 228 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Jena University Hospital Academic / other |
| Locations | 13 sites (Tübingen, Baden-Wurttemberg and 12 other locations) |
| Trial ID | NCT06534307 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tübingen, Baden-Wurttemberg and 12 other locations
- 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)
- 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)
- Universitätsklinikum Jena — Jena, Thuringia, Germany (Recruiting)
- Berlin Charité Campus Mitte — Berlin, Germany (Not_yet_recruiting)
- Berlin Vivantes Klinikum Neukölln — Berlin, Germany (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.