Clinical trial NCT04126863: Omphaloceles and Associated Malformations
Official title: Omphaloceles and Associated Malformations in Preterm and Term Newborns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Omphalocele
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 118
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm and term babies with omphalocele ≤ 28 days of life

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* preterm and term newborns ≤ 28 days
* present omphalocele

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of patients with Omphalocele
timeFrame: two years
measure: Number of patients with omphaloceles and associated malformations, especially pulmonary hypertension
timeFrame: two years
measure: Two-years outcome
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department of Neonatology
Study officials:
affiliation: University Childrens Hospital Tübingen
name: Christian Poets, Prof.
role: STUDY_DIRECTOR
References: