Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding
Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding: A Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: yeşim dilki, student
- Phone Number: +905010732834
- Email: yesimdilki@ogr.iuc.edu.tr
Study Contact Backup
- Name: gülçin bozkurt, Professor Doctor
- Phone Number: +905336349093
- Email: gbozkurt@iuc.edu.tr
Study Locations
-
-
darıca
-
Kocaeli, darıca, Turkey (Türkiye), 41000
- Recruiting
- Kocaeli Darıca Farabi Eğitim Ve Araştırma Hastanesi
-
Contact:
- yeşim dilki, student
- Phone Number: +905010732834
- Email: yesimdilki@ogr.iuc.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: THERMOREGULATION BUNDLE GROUP
Newborns in this group will receive a Thermoregulation Package immediately after birth. The package includes the following:
|
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.
|
|
Other: CONTROL GROUP
Newborns in this group will receive routine delivery room care according to the standard hospital protocol.
No structured thermoregulation bundle will be applied.
|
Standard delivery room care according to institutional protocol.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
neonatal body temperature stability
Time Frame: with in first 60 minutes postpartum
|
Body temperature (°C) of the newborn measured at 1, 5, 30, and 60 minutes after birth.
|
with in first 60 minutes postpartum
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time to first breastfeeding
Time Frame: within first 1 hours postpartum
|
The time (in minutes) from birth to the first successful latch
|
within first 1 hours postpartum
|
|
Early Breastfeeding Success
Time Frame: Within the first 1 hours postpartum
|
Breastfeeding success assessed using the LATCH breastfeeding assessment tool.
|
Within the first 1 hours postpartum
|
|
incidence of neonatal hypothermia
Time Frame: Within the first 60 minutes after birth
|
The proportion of newborns with axillary temperature <36.5°C.
|
Within the first 60 minutes after birth
|
|
Apgar score
Time Frame: At 1 and 5 minutes after birth
|
Assessed at 1 and 5 minutes after birth using the Apgar scoring system (range: 0-10).
Higher scores indicate better neonatal condition.
|
At 1 and 5 minutes after birth
|
|
Oxygen saturation (SpO₂)
Time Frame: Within the first 60 minutes after birth
|
Peripheral oxygen saturation (%) measured at 1, 5, 30, and 60 minutes after birth.
|
Within the first 60 minutes after birth
|
|
Heart rate
Time Frame: Within the first 60 minutes after birth
|
Heart rate (beats per minute) measured at 1, 5, 30, and 60 minutes after birth.
|
Within the first 60 minutes after birth
|
|
Respiratory rate
Time Frame: Within the first 60 minutes after birth
|
Respiratory rate (breaths per minute) measured at 1, 5, 30, and 60 minutes after birth.
|
Within the first 60 minutes after birth
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: gülçin bozkurt, Professor Doctor, istanbul üniversitesi cerrahpaşa sağlık bilimleri fakültesi
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- IstanbulUC-SBF-YD-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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