About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infants born at gestational age ≤ 32 weeks
Disqualifiers
Death before NICU discharge
Abdominal wall defects
Trial design
Single group
Treatments tested in this trial
skin to skin contact care
BehavioralEarly and regular skin to skin contact in NICU GA: \< 28 weeks: After the 72nd hour GA: 28 - 32 weeks: As soon as stabilization is ensured
Treatment groups
Trial outcomes
Primary outcomes
Mothers' Milk at Discharge
Number of infants receiving Exclusive Mothers' Milk at Discharge
Secondary outcomes
Intraventricular hemorrhage
Number of infants with intraventricular hemorrhage diagnosed by cranial ultrasound
Necrotizing enterocolitis (stage 2 and above)
Number of infants with necrotizing enterocolitis (stage 2 and above) according to Bell's criteria
Early neonatal sepsis
Number of infants with sepsis within first three days of admission; culture positive or clinical
Late neonatal sepsis
Number of infants with sepsis after the third day of admission; culture positive or clinical
Sponsors and contacts
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Baskent University Ankara Hospital
Lead sponsor
Ankara University
Collaborator
Gazi University
Collaborator
Hacettepe University
Collaborator
Marmara University
Collaborator
Umraniye Education and Research Hospital
Collaborator
Trakya University
Collaborator
Ege University
Collaborator
Ondokuz Mayıs University
Collaborator
Cukurova University
Collaborator
Sanliurfa Harran University
Collaborator
Cumhuriyet University
Collaborator
Uludag University
Collaborator
Kocaeli University
Collaborator
Aydin Adnan Menderes University
Collaborator
Konya City Hospital
Collaborator
Baskent University
Collaborator