NCT04760509

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

February 15, 2021

Last Update Submit

February 17, 2021

Conditions

Keywords

newbornneural tube defectsmeningomyelosel

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

Eligibility Criteria

Age0 Days - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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)

Location

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.

    BACKGROUND
  • McLone DG. Care of the neonate with a myelomeningocele. Neurosurg Clin N Am. 1998 Jan;9(1):111-20.

MeSH Terms

Conditions

Neural Tube Defects

Condition Hierarchy (Ancestors)

Nervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

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

Locations