Clinical trial NCT06543524: Survival and nEonatal outComes of veRy Low Birth wEight Infants in Türkiye: Turkish Neonatal Society SECRETS-TR Study
Official title: Survival and nEonatal outComes of veRy Low Birth wEight Infants in Türkiye: Turkish Neonatal Society SECRETS-TR Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbidity;Infant
Keywords: prematurity,
very low birth weight infant
outcomes
mortality
morbidity
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Turkish Neonatal Society
First posted: 2024-08-09
Enrollment: 3150
Sex: ALL
Minimum age (years): 60
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: mortality rate
timeFrame: during hospitalization period, with an average of 6 months.
measure: rate of prematurity-related morbidities
timeFrame: during hospitalization period or at the time of discharge whichever came first, assessed through study completion, an average of 6 months
Secondary outcomes:
measure: Duration of hospitalization
timeFrame: at the time of discharge of the Neonatal Intensive Care Unit (NICU), an average of 1 year.
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: BasaksehirCamSakuraSehirH
state: Please Select
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Merih Cetinkaya
role: PRINCIPAL_INVESTIGATOR
References: