NCT04126863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

October 12, 2023

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

September 19, 2019

Last Update Submit

October 11, 2023

Conditions

Omphalocele

Outcome Measures

Primary Outcomes (3)

  • 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

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Preterm and term babies with omphalocele ≤ 28 days of life

You may qualify if:

  • preterm and term newborns ≤ 28 days
  • present omphalocele

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neonatology

Tübingen, 72074, Germany

Location

MeSH Terms

Conditions

Hernia, Umbilical

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, VentralHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Christian Poets, Prof.

    University Childrens Hospital Tübingen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2019

First Posted

October 15, 2019

Study Start

July 1, 2019

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

October 12, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)