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

NCT06543524 | Completed

• 1 other identifier: TNS001
• Study Type: observational
• Target: 3,150
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbidity;Infant

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Duration of hospitalization

  at the time of discharge of the Neonatal Intensive Care Unit (NICU), an average of 1 year.

Interventions

Care of premature infants OTHER

No intervention was performed

Eligibility Criteria

• Age: 60 Minutes - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead
• Turkish Neonatal Society: collaborator

Study Sites (1)

BasaksehirCamSakuraSehirH

Istanbul, Please Select, 34552, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Merih Cetinkaya

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: August 9, 2024
• Study Start: April 28, 2021
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)