Actively Recruiting
Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding: A Randomized Controlled Trial
Led by Istanbul University - Cerrahpasa · Updated on 2026-05-05
140
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Maintaining a newborn's body temperature during the first hour after birth is crucial for survival and adapting to life outside the womb. This trial evaluates how a thermoregulation bundle applied at birth affects newborns' body temperature, breathing rate, heart rate, oxygen levels, and breastfeeding outcomes. The study focuses on healthy, full-term babies and aims to support successful breastfeeding through improved thermal care. The thermoregulation bundle includes keeping the delivery room temperature between 23-26 degrees Celsius, immediate skin-to-skin contact, drying the baby starting from the head with a warm towel, placing a hat on the baby, covering the baby with a warm towel during skin-to-skin contact, and initiating breastfeeding within the first 30-60 minutes. One group of newborns receives this bundle, while the control group receives routine care following standard hospital protocols. Participants will be monitored closely during the first hour after birth for body temperature stability, heart rate, respiratory rate, oxygen saturation, and Apgar scores at 1 and 5 minutes. Researchers will also record the time to first breastfeeding and early breastfeeding success. The study begins shortly after birth and measures outcomes within 60 minutes postpartum, focusing on both physiological stability and breastfeeding initiation.
CONDITIONS
Brief Title
Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The baby is born vaginally
- It is a singleton pregnancy
- The baby is born at term (gestational age 38-42 weeks)
- The baby's Apgar score is 27 7 at 1 minute
- The baby's birth weight is between 2500-4000 grams
- The baby is exclusively breastfed
- The baby has no problems preventing breastfeeding
- The mother has no problems preventing breastfeeding
- There are no maternal or fetal complications
You will not qualify if you...
- The baby being preterm or postterm
- Starting formula feeding
- The baby having special care needs such as intensive care
- The baby having intrauterine growth restriction (IUGR), genetic disease, or similar conditions
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 - First hour after birth
Participants receive either the Thermoregulation Bundle immediately after birth, which includes maintaining delivery room temperature, immediate drying with warm linens, application of a hat, early skin-to-skin contact for the first hour, and covering the newborn with a warm blanket, or routine delivery room care according to hospital protocol.
1 visit at birth (in-person)
Duration - Within first 60 minutes postpartum
Participants are monitored for neonatal physiological parameters such as body temperature stability, Apgar score, oxygen saturation, heart rate, respiratory rate, and early breastfeeding success within the first 60 minutes after birth.
Continuous monitoring during the first hour after birth
Trial Site Locations
Total: 1 location
1
Kocaeli Darıca Farabi Eğitim Ve Araştırma Hastanesi
Kocaeli, darıca, Turkey (Türkiye), 41000
Actively Recruiting
Research Team
Y
yeşim dilki, student
G
gülçin bozkurt, Professor Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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