NCT06543524

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,150 (actual)
• Sponsor: Başakşehir Çam & Sakura City Hospital · Other Government
• Sex: All
• Age: 60 Minutes – 1 Day
• Healthy volunteers: Not accepted

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.

Conditions

• Morbidity;Infant

Interventions

Type	Name	Description
OTHER	Care of premature infants	No intervention was performed

Timeline

• Start date: 2021-04-28
• Primary completion: 2023-09-28
• Completion: 2023-09-28
• First posted: 2024-08-09
• Last updated: 2024-08-09

Locations

1 site across 1 country: Turkey (Türkiye)