Omphaloceles and Associated Malformations

Omphalocele Clinical Trial

Official title:

Omphaloceles and Associated Malformations in Preterm and Term Newborns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04126863
• Other study ID #: 425/2019BO1
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2022
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• preterm and term newborns = 28 days

• present omphalocele

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Hernia, Umbilical
• Omphalocele

Locations

Country	Name	City	State
Germany	Department of Neonatology	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

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