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

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.

Study Overview

• Status: Completed
• Conditions: Morbidity;Infant
• Intervention / Treatment: Other: Care of premature infants

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 Type: Observational
• Enrollment (Actual): 3150

Contacts and Locations

Study Locations

• Turkey
  • Please Select
    • İstanbul, Please Select, Turkey, 34552
      • BasaksehirCamSakuraSehirH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality rate	mortality rate of infants participated to the study	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	during hospitalization period or at the time of discharge whichever came first, assessed through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospitalization	Length of hospitalization as day	at the time of discharge of the Neonatal Intensive Care Unit (NICU), an average of 1 year.

Collaborators and Investigators

• Sponsor: Başakşehir Çam & Sakura City Hospital
• Collaborators: Turkish Neonatal Society
• Investigators: Principal Investigator: Merih Cetinkaya, Başakşehir Çam & Sakura City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): September 28, 2023

Study Registration Dates

• First Submitted: July 28, 2024
• First Submitted That Met QC Criteria: August 4, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: outcomes; mortality; morbidity; very low birth weight infant; prematurity,
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: TNS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No