Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543524
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Survival and nEonatal outComes of veRy Low Birth wEight Infants in Türkiye Turkish Neonatal Society SECRETS-TR Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Survival and nEonatal outComes of veRy Low Birth wEight Infants in Türkiye Turkish Neonatal Society SECRETS-TR Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TNS-SECRETS
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 BW1500 grams and with gestational age GA of 24 07 weeks to 31 67 weeks all inborn and outborn infants admitted to NICU within the first 24 hours of life and approval of parental consentThe survival status maternal perinatal and neonatal characteristics risk factors and early neonatal outcomes of all infants were recorded
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 BW1500 grams and with gestational age GA of 24 07 weeks to 31 67 weeks all inborn and outborn infants admitted to NICU within the first 24 hours of life and approval of parental consentThe 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 IIIIV neonatal intensive care units NICUs Detailed information on antenatal growth infection natal neonatal resuscitation non-invasiveinvasive ventilation and surfactant administration in the delivery room and postnatal clinical course in NICUs ventilatory support circulation intestinal and cranial event statusgrowth 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None