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Survival and nEonatal outComes of veRy Low Birth wEight Infants in Türkiye: Turkish Neonatal Society SECRETS-TR Study

Survival and nEonatal outComes of veRy Low Birth wEight Infants in Türkiye: Turkish Neonatal Society SECRETS-TR Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06543524
Acronym
TNS-SECRETS
Enrollment
3150
Registered
2024-08-09
Start date
2021-04-28
Completion date
2023-09-28
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbidity;Infant

Keywords

prematurity,, very low birth weight infant, outcomes, mortality, morbidity

Brief 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. 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.

Interventions

OTHERCare of premature infants

No intervention was performed

Sponsors

Turkish Neonatal Society
CollaboratorOTHER
Başakşehir Çam & Sakura City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Minutes to 1 Days
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
mortality rateduring hospitalization period, with an average of 6 months.mortality rate of infants participated to the study
rate of prematurity-related morbiditiesduring hospitalization period or at the time of discharge whichever came first, assessed through study completion, an average of 6 monthsrates of prematurity-related morbidities in infants participated to the study

Secondary

MeasureTime frameDescription
Duration of hospitalizationat the time of discharge of the Neonatal Intensive Care Unit (NICU), an average of 1 year.Length of hospitalization as day

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026