Omphaloceles and Associated Malformations

Omphaloceles and Associated Malformations in Preterm and Term Newborns

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.

Study Overview

• Status: Completed
• Conditions: Omphalocele

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 Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

• Study Contact: Name: Kerstin Gründler, Dr.; Phone Number: 07071-29-82621; Email: Kerstin.Gruendler@med.uni-tuebingen.de
• Study Contact Backup: Name: Rangmar Goelz, Dr.; Phone Number: 07071-29-82621; Email: Rangmar.Goelz@med.uni-tuebingen.de

Study Locations

• Germany
  • Tübingen, Germany, 72074
    • Department of Neonatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Preterm and term babies with omphalocele ≤ 28 days of life

Description

Inclusion Criteria:

• preterm and term newborns ≤ 28 days
• present omphalocele

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Omphalocele	Collection of data to calculate the prevalence of omphaloceles	two years
Number of patients with omphaloceles and associated malformations, especially pulmonary hypertension	Collection of data to calculate the prevalence of omphalocele associated malformations	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)	two years

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Study Director: Christian Poets, Prof., University Childrens Hospital Tübingen

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral; Hernia, Umbilical
• Other Study ID Numbers: 425/2019BO1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No