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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05033275
Other study ID # 2047262
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date May 30, 2024

Study information

Verified date May 2024
Source University of Missouri-Columbia
Contact Akshaya Vachharajani, MD
Phone 5738822282
Email vachharajaniaj@health.missouri.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Babies born to mothers with pregestational diabetes will be screened with parental consent for sacral agenesis


Description:

Parent/s of babies born to mothers with pregestational diabetes who have normal clinical examination and have no radiographs showing a normal sacrum will be approached for a spinal US


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date May 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Infants born to mothers with pregestational diabetes - Normal spinal examination Exclusion Criteria: - Infants born to mothers with pregestational diabetes - Abnormal spinal examination such as a sacral dimple - Radiograph with abnormal sacrum - Spanish speaking parents

Study Design


Locations

Country Name City State
United States MU Columbia Missouri

Sponsors (1)

Lead Sponsor Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Babies with sacral agenesis identified with screening of asymptomatic babies with a spinal ultrasound All babies who have tethered cord on spinal US will be referred to neurosurgery 12 months
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