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

• ClinicalTrials.gov Identifier: NCT04760509
• Recruitment Status: Active, not recruiting
• First Posted: February 18, 2021
• Last Update Posted: February 18, 2021
• Sponsor: Hacettepe University
• Information provided by (Responsible Party): Umit Ayse Tandircioglu, Hacettepe University

Study Description

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.

Condition or disease	Intervention/treatment
Neural Tube Defects; Newborn Morbidity	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.

Detailed 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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 80 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Short- Term Follow up Of Neonates Born With Neural Tube Defect
• Actual Study Start Date: February 1, 2021
• Estimated Primary Completion Date: September 30, 2021
• Estimated Study Completion Date: December 31, 2021

Groups and Cohorts

Intervention Details:

• 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.
  Other Name: meningomyelosel

Outcome Measures

Primary Outcome Measures :

1. the day of surgery to be performed in the postnatal period [ Time Frame: 8 months ]
   It is aimed to demonstrate the effects of early or late surgery day on the baby in the postnatal period.

Eligibility Criteria

• Ages Eligible for Study: up to 28 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-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.

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Contacts and Locations

Locations

Turkey

Umit Ayse Tandircioglu

Ankara, Turkey, 06230

Sponsors and Collaborators

Hacettepe University

More Information

Publications of Results:

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

Other Publications:

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.

• Responsible Party: Umit Ayse Tandircioglu, Medical Doctor, Hacettepe University
• ClinicalTrials.gov Identifier: NCT04760509
• Other Study ID Numbers: GO201150
• First Posted: February 18, 2021
• Last Update Posted: February 18, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: The method and data collection tools of the study: The committee, 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Umit Ayse Tandircioglu, Hacettepe University:

newborn; neural tube defects; meningomyelosel

Additional relevant MeSH terms:

Neural Tube Defects; Spinal Dysraphism; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities