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Recruiting Not applicable

Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding

NCT07453264 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-11-01
Last updated
2026-05-05

Condition(s) studied

ThermoregulationNeonatal HypothermiaNeonatal Adaptation

Investigational drug(s) / intervention(s)

Thermoregulation bundleroutine care

Thermoregulation bundle: A structured set of evidence-based thermal care interventions applied immediately after birth, including maintaining appropriate delivery room temperature, immediate drying with warm linens, removal of wet towels, application of a hat, early skin-to-skin contact for the first hour, and covering the newborn with a warm blanket. The bundle is implemented using an all-or-nothing approach.

routine care: Standard delivery room care according to institutional protocol.

Study summary

Maintaining neonatal body temperature (thermoregulation), particularly during the first hour after birth, is critical for survival and successful adaptation to the extrauterine environment. Implementation of a thermoregulation bundle is expected to facilitate faster stabilization of physiological parameters and to positively influence the initiation of breastfeeding as well as overall breastfeeding success. The effects of a thermoregulation bundle applied at birth on neonatal physiological parameters-including body temperature, respiratory rate, heart rate, and oxygen saturation-and on breastfeeding outcomes will be evaluated.

Eligibility

Sex
ALL
Min age
2 Hours
Max age
2 Hours
Healthy volunteers
No
Inclusion Criteria: * 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 ≥ 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. Exclusion Criteria: * The baby being preterm/postterm, * Starting formula feeding, * The baby having special care needs (intensive care, etc.), * The baby having intrauterine growth restriction (IUGR), genetic disease, etc.

Primary outcome measure(s)

  • neonatal body temperature stability — with in first 60 minutes postpartum
    Body temperature (°C) of the newborn measured at 1, 5, 30, and 60 minutes after birth.

Trial sites (1)

FacilityCityRegionStatus
Kocaeli Darıca Farabi Eğitim Ve Araştırma Hastanesi Kocaeli darıca Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07453264 on ClinicalTrials.gov ↗ ← All trials in Turkey