An observational study in Omphalocele, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2023-10-12.
Sponsored by University Hospital Tuebingen · Observational
Major birth defects like omphalocele are diagnosed in 3-8% of all newborns in Germany each year. Prevention and treatment quality of congenital malformations are key concerns for child health. Poor long-term outcome is more likely in the presence of associated structural or chromosomal abnormalities that occur in approximately 50-77% of these infants. Furthermore, many newborns have respiratory failure and supposedly pulmonary hypertension - another reason for increased mortality.
As part of the Surveillance Unit for Rare Pediatric Conditions in Germany (Erhebungseinheit für seltene pädiatrische Erkrankungen in Deutschland), all neonatological departments receive over two years monthly reporting cards to notify the study centre of cases, which will be analysed based on anonymised questionnaires.
An observational study using anonymized questionnaires, enrolled over two years (01/07/2019 - 30/06/2021) via the Surveillance Unit for Rare Pediatric Conditions in Germany (ESPED - Erhebungseinheit für seltene pädiatrische Erkrankungen in Deutschland). The nationwide epidemiological data collection contents information about the incidence of omphalocele, associated malformations and risk factors for the occurrence of omphalocele, especially for pulmonary hypertension and its treatment.
We use the following inclusion criteria: preterm and term babies' ≤ 28 days of life.
The aim of our study is a reliable, population-related data acquisition about prevalence of omphalocele, associated malformations and possible risk factors and characteristic early warning symptoms regarding concomitant diseases. Thereby, in the future it will be possible to develop prevention strategies für early detection and treatment of omphalocele and the associated malformations/ diseases to improve outcome for these babies. A further aim is to follow-up the thriving and the psychomotor development of these babies in the age of two years.
67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.
This study's enrollment of 118 is close to the median of 118 across 25 observational studies indexed under Hernia, Umbilical.
Browse Hernia, Umbilical studies →University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.
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Preterm and term babies with omphalocele ≤ 28 days of life
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Exclusion Criteria:
Number of patients with Omphalocele
Collection of data to calculate the prevalence of omphaloceles
Time frame: two years
Number of patients with omphaloceles and associated malformations, especially pulmonary hypertension
Collection of data to calculate the prevalence of omphalocele associated malformations
Time frame: two years
Two-years outcome
Monitoring of weighting and thriving and of psychomotor development on the basis of a general developmental screening tool (ages \& stages questionnaire)
Time frame: two years
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2019 to primary completion in Jun 2022, 35 months.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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