Omphaloceles and Associated Malformations

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.

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Key information

Conditions

Omphalocele Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Abdominal Hernia, Umbilical Hernia, Ventral Infant, Newborn, Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neonatology

Tübingen, 72074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

preterm and term newborns ≤ 28 days
present omphalocele

Exclusion criteria

none

Treatment and study plan

Primary outcomes

Number of patients with Omphalocele

Time frame: two years

Collection of data to calculate the prevalence of omphaloceles
Number of patients with omphaloceles and associated malformations, especially pulmonary hypertension

Time frame: two years

Collection of data to calculate the prevalence of omphalocele associated malformations
Two-years outcome

Time frame: two years

Monitoring of weighting and thriving and of psychomotor development on the basis of a general developmental screening tool (ages & stages questionnaire)

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Omphaloceles and Associated Malformations in Preterm and Term Newborns

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Oct 15, 2019
Registry last updated: Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed