Short- Term Follow up Of Neonates Born With Neural Tube Defect

Newborn Morbidity Clinical Trial

— STFUONBWNTD  

Official title:

Short- Term Follow up Of Neonates Born With Neural Tube Defect

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04760509
• Other study ID #: GO201150
• Status: Active, not recruiting
• Start date: February 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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 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 neonatal surgery intensive care unit for the last fifteen years will be evaluated retrospectively.Information of patients hospitalized with a diagnosis of neural tube defect in the neonatal intensive care unit 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 of patients, maternal diseases, birth weights, birth weeks, delivery types, neurological examinations, laboratory findings, imaging (such as graphy, tomography, ultrasonography), surgery notes, additional anomalies from the hospital system retrospectively will be saved. Immediately after babies with NTD are born, the defect should be protected in the delivery room with a wet sterile sponge and the baby should be placed in a lateral or prone position. Since the risk of meningitis is high and the destruction of the neural tissue within the pouch will increase within days, the sac repair should be performed within the first 72 hours. Antibiotics should be initiated empirically in these patients with high risk of meningitis. In the postoperative follow-up; The patient should be monitored in terms of wound infection of the repaired sac, bosom leakage, fistula formation and hydrocephalus. In this study, the short-term follow-up of patients with neural tube defects in the neonatal intensive care unit will be evaluated retrospectively. As a result of this data evaluation to be made over the hospital information system, "Hacettepe University Neonatal Intensive Care Unit patient follow-up with NTD" will contribute to the literature.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• Babies who have been hospitalized in the Neonatal Intensive Care Unit of Hacettepe University Ihsan Dogramaci Children's Hospital and who have been operated due to neural tube defects will be taken.

Exclusion Criteria:

• Patients whose file records cannot be reached will not be included.

Related Conditions & MeSH terms

• Neural Tube Defects
• Newborn Morbidity
• Spinal Dysraphism

Intervention

Other:
• In this study, the short-term follow-up of patients with neural tube defects in the neonatal intensive care unit will be evaluated retrospectively.
there is no intervention. It is retrospective study.

Locations

Country	Name	City	State
Turkey	Umit Ayse Tandircioglu	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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