Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-2
SponsorIstanbul University - Cerrahpasa
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Thermoregulation bundle
Other interventionA 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
Other interventionStandard delivery room care according to institutional protocol.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: THERMOREGULATION BUNDLE GROUPExperimental treatment 1 intervention
Group B: CONTROL GROUPOther 1 intervention
Trial outcomes
Primary outcomes
1
neonatal body temperature stability
Body temperature (°C) of the newborn measured at 1, 5, 30, and 60 minutes after birth.
Time frame
with in first 60 minutes postpartumSecondary outcomes
1
time to first breastfeeding
The time (in minutes) from birth to the first successful latch
Time frame
within first 1 hours postpartum2
Early Breastfeeding Success
Breastfeeding success assessed using the LATCH breastfeeding assessment tool.
Time frame
Within the first 1 hours postpartum3
incidence of neonatal hypothermia
The proportion of newborns with axillary temperature \<36.5°C.
Time frame
Within the first 60 minutes after birth4
Apgar score
Assessed at 1 and 5 minutes after birth using the Apgar scoring system (range: 0-10). Higher scores indicate better neonatal condition.
Time frame
At 1 and 5 minutes after birthSponsors and contacts
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Source ClinicalTrials.gov