Short- Term Follow up Of Neonates Born With Neural Tube Defect
STFUONBWNTD
1 other identifier
observational
80
1 country
1
Brief Summary
Neural tube defects (NTD), which is the most common anomaly of the central nervous system, which can be diagnosed during antenatal period, brings many problems both in the neonatal period and in advanced ages. Open neural tube defects, in particular, progress with sensory-motor deficits due to the risk of infection and neural tissue loss from birth, and should be followed closely from the neonatal period. Newborns born with a neural tube defect should be operated within the first 72 hours postnatal and the defect should be closed. In this hospital, newborns with NTD are monitored in our neonatal surgery intensive care unit before and after surgery. Neonatal specialists, neurosurgeons and other specialists when there is an additional anomaly evaluate the baby as multidisciplinary. In this project, the short-term follow-up data of babies with NTD who have been followed up in this neonatal surgery intensive care unit for the last fifteen years will be evaluated retrospectively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 15, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFebruary 18, 2021
February 1, 2021
8 months
February 15, 2021
February 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the day of surgery to be performed in the postnatal period
It is aimed to demonstrate the effects of early or late surgery day on the baby in the postnatal period.
8 months
Interventions
there is no intervention. It is retrospective study.
Eligibility Criteria
The method and data collection tools of the study: the information of the patients hospitalized in the neonatal intensive care unit with a diagnosis of neural tube defect between January 1, 2006 and January 1, 2021 will be recorded in the file. In addition to demographic information such as antenatal follow-up data, maternal diseases, birth weights, birth weeks, delivery types of patients, neurological examinations, laboratory findings, imaging (such as graphy, tomography, ultrasonography), surgery during the follow-up in our unit.
You may qualify if:
- Babies who have been hospitalized in the Neonatal Intensive Care Unit of Hacettepe University İhsan Dogramaci Children's Hospital and who have been operated due to neural tube defects will be taken.
You may not qualify if:
- Patients whose file records cannot be reached will not be included.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Umit Ayse Tandircioglu
Ankara, 06230, Turkey (Türkiye)
Related Publications (2)
Richard J. Martin, MBBS, FRACP, Avroy A. Fanaroff, MD, FRCPE, FRCPCH, Michele C. Walsh, MD, MSE Fanaroff and Martin's Neonatal-Perinatal Medicine. Diseases of the Fetus and Infant. 11th Edition 1073- 1080.
BACKGROUNDMcLone DG. Care of the neonate with a myelomeningocele. Neurosurg Clin N Am. 1998 Jan;9(1):111-20.
PMID: 9405769RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
February 15, 2021
First Posted
February 18, 2021
Study Start
February 1, 2021
Primary Completion
September 30, 2021
Study Completion
December 31, 2021
Last Updated
February 18, 2021
Record last verified: 2021-02