Omphaloceles and Associated Malformations

Completed

• Conditions: Omphalocele

• Registration Number: NCT04126863
• Lead Sponsor: University Hospital Tuebingen

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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-15
• Status Verified: 2022-05
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• preterm and term newborns ≤ 28 days
• present omphalocele

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with Omphalocele	two years	Collection of data to calculate the prevalence of omphaloceles
Two-years outcome	two years	Monitoring of weighting and thriving and of psychomotor development on the basis of a general developmental screening tool (ages \& stages questionnaire)
Number of patients with omphaloceles and associated malformations, especially pulmonary hypertension	two years	Collection of data to calculate the prevalence of omphalocele associated malformations

Trial Locations

Locations (1)

Department of Neonatology; 🇩🇪 Tübingen, Germany