Morbidity;InfantTNS-SECRETSNCT06543524
Survival and nEonatal outComes of veRy Low Birth wEight Infants in Türkiye: Turkish Neonatal Society SECRETS-TR Study
An observational study of Morbidity;Infant, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this multi-center study was to evaluate the mortality rate and early neonatal outcomes of very low birth weight (VLBW) infants hospitalized in neonatal intensive care units (NICUs) in Türkiye. Read more about this study
- Who is it for?
- Ages 60 minutes to 1 day
- Conditions the study is for
- Morbidity;Infant
- What is being tested?
- Care of premature infants
- How many people
- 3,150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Apr 2021to 28 Sep 2023
- 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 60 minutes to 1 day
- All sexes
- No healthy volunteers
- Child
Study population: Very low birth weight preterm infants with BW≤1500 grams and with gestational age (GA) of 24 0/7 weeks to 31 6/7 weeks and admitted to NICU within the first 24 hours of life
Who may be able to join
- Preterm infants with BW≤1500 grams and with gestational age (GA) of 24 0/7 weeks to 31 6/7 weeks,
- All inborn and outborn infants admitted to NICU within the first 24 hours of life
- Presence of parental consent
Who cannot join
- The larger infants than inclusion criteria,
- Infants who died in the delivery room,
- Infants admitted to NICU after first 24 hours of life,
- Infants with major congenital/chromosomal abnormalities
- Refusal of parental consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
BasaksehirCamSakuraSehirH
Istanbul, Please Select, 34552
About this study
The aim of this multi-center study was to evaluate the mortality rate and early neonatal outcomes of very low birth weight (VLBW) infants hospitalized in neonatal intensive care units (NICUs) in Türkiye. It was promoted by the Turkish Neonatology Society (TNS) and research was approved by the Cam and Sakura City Hospital Ethical Committee.
It was conducted between 28 April 2021 and 02 January 2023 and written informed consents from the families of included patients were obtained.
Read more
A total of 74 level III and IV NICUs participated to the study. All the centers had an oppurtunity to follow-up these high risk premature infants in terms of their medical staff, equipment and other neonatology sources.
The inclusion criteria consisted of preterm infants with birth weight (BW)≤1500 grams and with gestational age (GA) of 24 0/7 weeks to 31 6/7 weeks, all inborn and outborn infants admitted to NICU within the first 24 hours of life and approval of parental consent.The survival status, maternal, perinatal and neonatal characteristics, risk factors and early neonatal outcomes of all infants were recorded.
Read the detailed description
The study includes the selected cohort of approximately 3000 very low birth weight preterm infants born in one year period in Turkey in level III/IV neonatal intensive care units (NICUs). Detailed information on antenatal (growth, infection), natal (neonatal resuscitation, non-invasive/invasive ventilation and surfactant administration in the delivery room) and postnatal clinical course in NICUs (ventilatory support, circulation, intestinal and cranial event status,growth, exitus) were recorded. The mortality and overall spesific morbidities of the study population will be evaluated. Also, subgroup analysis for extremely low birth weight infants, micropremies, gray zone infants (22 to 24 weeks of gestational age) will also be performed for local data of Turkey and will be used for development of local guidelines and improvements in the care of preterm infants.
- Conditions
- Morbidity;Infant
- Being tested
- Care of premature infants
- Keywords
- prematurity,, very low birth weight infant, outcomes, mortality, morbidity
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care of premature infantsOther
No intervention was performed
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
mortality rate of infants participated to the study
Measured: during hospitalization period, with an average of 6 months.
rate of prematurity-related morbidities
rates of prematurity-related morbidities in infants participated to the study
Measured: during hospitalization period or at the time of discharge whichever came first, assessed through study completion, an average of 6 months
Secondary outcomes (1)
Duration of hospitalization
Length of hospitalization as day
Measured: at the time of discharge of the Neonatal Intensive Care Unit (NICU), an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start28 Apr 2021
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbidity;InfantStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Collaborators
- Turkish Neonatal Society
- Responsible party
- Principal investigator, Merih CETINKAYA, Başakşehir Çam & Sakura City Hospital
- Investigators
- Merih Cetinkaya, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543524
- Sponsor's protocol ID
- TNS001
- Acronym
- TNS-SECRETS
- Status last verified
- Aug 2024
- First submitted
- 28 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival and nEonatal outComes of veRy Low Birth wEight Infants in Türkiye: Turkish Neonatal Society SECRETS-TR Study
- ClinicalTrials.gov ID
- NCT06543524
- Acronym / sponsor ID
- TNS-SECRETS / TNS001
- Conditions
- Morbidity;Infant
- Keywords
- prematurity,, very low birth weight infant, outcomes, mortality, morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,150 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Collaborators
- Turkish Neonatal Society
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 9 Aug 2024 (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.
The aim of this multi-center study was to evaluate the mortality rate and early neonatal outcomes of very low birth weight (VLBW) infants hospitalized in neonatal intensive care units (NICUs) in Türkiye. It was promoted by the Turkish Neonatology Society (TNS) and research was approved by the Cam and Sakura City Hospital Ethical Committee.
It was conducted between 28 April 2021 and 02 January 2023 and written informed consents from the families of included patients were obtained.
A total of 74 level III and IV NICUs participated to the study. All the centers had an oppurtunity to follow-up these high risk premature infants in terms of their medical staff, equipment and other neonatology sources.
The inclusion criteria consisted of preterm infants with birth weight (BW)≤1500 grams and with gestational age (GA) of 24 0/7 weeks to 31 6/7 weeks, all inborn and outborn infants admitted to NICU within the first 24 hours of life and approval of parental consent.The survival status, maternal, perinatal and neonatal characteristics, risk factors and early neonatal outcomes of all infants were recorded.
Detailed description
The study includes the selected cohort of approximately 3000 very low birth weight preterm infants born in one year period in Turkey in level III/IV neonatal intensive care units (NICUs). Detailed information on antenatal (growth, infection), natal (neonatal resuscitation, non-invasive/invasive ventilation and surfactant administration in the delivery room) and postnatal clinical course in NICUs (ventilatory support, circulation, intestinal and cranial event status,growth, exitus) were recorded. The mortality and overall spesific morbidities of the study population will be evaluated. Also, subgroup analysis for extremely low birth weight infants, micropremies, gray zone infants (22 to 24 weeks of gestational age) will also be performed for local data of Turkey and will be used for development of local guidelines and improvements in the care of preterm infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 minutes to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Very low birth weight preterm infants with BW≤1500 grams and with gestational age (GA) of 24 0/7 weeks to 31 6/7 weeks and admitted to NICU within the first 24 hours of life
Key inclusion criteria (3 listed)
- Preterm infants with BW≤1500 grams and with gestational age (GA) of 24 0/7 weeks to 31 6/7 weeks,
- All inborn and outborn infants admitted to NICU within the first 24 hours of life
- Presence of parental consent
Key exclusion criteria (5 listed)
- The larger infants than inclusion criteria,
- Infants who died in the delivery room,
- Infants admitted to NICU after first 24 hours of life,
- Infants with major congenital/chromosomal abnormalities
- Refusal of parental consent
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 |
|---|---|---|
| Care of premature infantsNo intervention was performed | Other | – |
Primary outcome
mortality rate
Time frame: during hospitalization period, with an average of 6 months.
mortality rate of infants participated to the study
rate of prematurity-related morbidities
Time frame: during hospitalization period or at the time of discharge whichever came first, assessed through study completion, an average of 6 months
rates of prematurity-related morbidities in infants participated to the study
1 secondary outcome
Duration of hospitalization
Time frame: at the time of discharge of the Neonatal Intensive Care Unit (NICU), an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Merih Cetinkaya principal investigator
Başakşehir Çam & Sakura City Hospital
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 Morbidity;Infant, run by Başakşehir Çam & Sakura City Hospital 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 9 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
mortality rate (time frame: during hospitalization period, with an average of 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2024.