Neural Tube DefectsSTFUONBWNTDNCT04760509
Short- Term Follow up Of Neonates Born With Neural Tube Defect
An observational study of Neural Tube Defects and Newborn Morbidity, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Neural Tube Defects, Newborn Morbidity
- What is being tested?
- In this study, the short-term follow-up of patients with neural tube defects in the neonatal intensive care unit will be evaluated retrospectively.
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Patients whose file records cannot be reached will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Neural Tube Defects, Newborn Morbidity
- Being tested
- In this study, the short-term follow-up of patients with neural tube defects in the neonatal intensive care unit will be evaluated retrospectively.
- Keywords
- newborn, neural tube defects, meningomyelosel
- Medical subject headings
- Neural Tube Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In this study, the short-term follow-up of patients with neural tube defects in the neonatal intensive care unit will be evaluated retrospectively.Other
Also called meningomyelosel
there is no intervention. It is retrospective study.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Feb 2021
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neural Tube DefectsStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umit Ayse Tandircioglu, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760509
- Sponsor's protocol ID
- GO201150
- Acronym
- STFUONBWNTD
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
McLone DG. Care of the neonate with a myelomeningocele. Neurosurg Clin N Am. 1998 Jan;9(1):111-20.
PubMed 9405769
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short- Term Follow up Of Neonates Born With Neural Tube Defect
- ClinicalTrials.gov ID
- NCT04760509
- Acronym / sponsor ID
- STFUONBWNTD / GO201150
- Conditions
- Neural Tube Defects, Newborn Morbidity
- Keywords
- newborn, neural tube defects, meningomyelosel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients whose file records cannot be reached will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In this study, the short-term follow-up of patients with neural tube defects in the neonatal intensive care unit will be evaluated retrospectively.Also: meningomyeloselthere is no intervention. It is retrospective study. | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- BackgroundRichard 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.
- Results publication: PubMed 9405769McLone DG. Care of the neonate with a myelomeningocele. Neurosurg Clin N Am. 1998 Jan;9(1):111-20.
- Individual participant dataSharing planned: Undecided. 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.
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Neural Tube Defects (NTDs)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neural Tube Defects and Newborn Morbidity, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the day of surgery to be performed in the postnatal period (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04760509, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.