Actively Recruiting
Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study
Led by Baskent University Ankara Hospital · Updated on 2024-11-04
120
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
B
Baskent University Ankara Hospital
Lead Sponsor
A
Ankara University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how standardized skin-to-skin care in neonatal intensive care units (NICUs) affects preterm infants born at or before 32 weeks of gestation. This multi-center, prospective clinical study led by the Turkish Neonatal Society aims to see if early and regular skin-to-skin contact increases the rate of exclusive mothers' milk feeding at discharge and improves clinical outcomes such as reducing neonatal sepsis, intraventricular hemorrhage, necrotizing enterocolitis, and shortening hospital stays. The study involves eight hospitals across Turkey where staff receive training on a protocol for skin-to-skin care. The care is started early—after 72 hours for infants born before 28 weeks and as soon as stable for those born between 28 and 32 weeks—and is applied regularly for at least one hour per session. Data is collected from two groups: infants discharged in the two months before staff training and infants discharged four to six months after training, comparing outcomes before and after the intervention. Participants' feeding details and clinical outcomes are recorded during their hospital stay and at discharge. Researchers track the rate of exclusive mothers' milk feeding as the primary outcome. Secondary outcomes include rates of serious infections, brain hemorrhage, severe intestinal disease, and hospital stay length. The study continues until discharge, averaging about three months, with data analyzed to understand the impact of the skin-to-skin care protocol.
CONDITIONS
Brief Title
Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born at gestational age ≤ 32 weeks
You will not qualify if you...
- Death before NICU discharge
- Abdominal wall defects
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until NICU discharge, approximately up to 3 months
Participants receive early and regular skin-to-skin care sessions in the neonatal intensive care unit, following a standardized protocol tailored to gestational age and stabilization status.
Daily skin-to-skin care sessions lasting at least one hour each
Duration - Up to discharge, approximately 3 months
Data on clinical outcomes such as feeding type at discharge, neonatal infections, intraventricular hemorrhage, necrotizing enterocolitis, and length of hospital stay are collected and analyzed.
Assessments at discharge
Trial Site Locations
Total: 1 location
1
Baskent University
Ankara, Turkey (Türkiye)
Actively Recruiting
Research Team
S
Sezin Unal, Prof, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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