Clinical Trial

Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study

Study acronym: TR-SSCinNICU
Recruiting
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Record status
This record was last updated November 4, 2024 (before its estimated April 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study is a multi-center, prospective pre-post clinical study conducted under the leadership of the Turkish Neonatal Society. It aims to investigate the effects of a standardized skin-to-skin care in NICU, initiated early and applied regularly, on recieving exclusive mothers' milk at discharge and clinical outcomes for preterm infants born ≤ 32 weeks of gestation. 1. Primary Objective: To evaluate the rate of receiving exclusive mothers' milk at discharge for infants born ≤ 32 weeks of gestation who have received skin-to-skin care in accordance with the study protocol. 2. Secondary Objective: To evaluate the rates of neonatal sepsis, intraventricular hemorrhage, and necrotizing enterocolitis (stage 2 and above) as well as the length of hospital stay for infants born at or below 32 weeks of gestation who have received skin-to-skin care in accordance with the study protocol.
Trial Details
NCT Number NCT06672913
Lead Sponsor Baskent University Ankara Hospital
Collaborators: Ankara University, Gazi University, Hacettepe University, Marmara University, Umraniye Education and Research Hospital, Trakya University, Ege University, Ondokuz Mayıs University, Cukurova University, Sanliurfa Harran University, Cumhuriyet University, Uludag University, Kocaeli University, Aydin Adnan Menderes University, Konya City Hospital, Baskent University
Conditions Premature, Skin to Skin Contact, Breast Feeding, Necrotizing Enterocolitis, Retinopathy of Prematurity
Enrollment 120 participants
Start Date 2024-09-01
Primary Completion 2025-04-01 (estimated)
Study Completion 2025-06-01 (estimated)
Updated on ClinicalTrials.gov 2024-11-04