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

NCT07453264 | Recruiting

• 1 other identifier: IstanbulUC-SBF-YD-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thermoregulation; Neonatal Hypothermia; Neonatal Adaptation

Keywords

thermoregulation bundle; term newborn; neonatal hypothermia; skin-to-skin contact; delivery room care; physiological parameters

Outcome Measures

Primary Outcomes (1)

• neonatal body temperature stability

  Body temperature (°C) of the newborn measured at 1, 5, 30, and 60 minutes after birth.

  with in first 60 minutes postpartum

Secondary Outcomes (7)

• time to first breastfeeding

  within first 1 hours postpartum

• Early Breastfeeding Success

  Within the first 1 hours postpartum

• incidence of neonatal hypothermia

  Within the first 60 minutes after birth

• Apgar score

  At 1 and 5 minutes after birth

• Oxygen saturation (SpO₂)

  Within the first 60 minutes after birth

Study Arms (2)

THERMOREGULATION BUNDLE GROUP

EXPERIMENTAL

Newborns in this group will receive a Thermoregulation Package immediately after birth. The package includes the following: 1. The delivery room temperature should be between 23-26 degrees Celsius. 2. Skin-to-skin contact should be initiated as soon as the baby is born. 3. The baby should be dried starting from the head with a warm towel and a hat should be put on. 4. The baby should be covered with a warm towel during skin-to-skin contact. 5. The baby should be breastfed immediately (within the first 30-60 minutes). All components of the package will be applied according to an all-or-nothing approach.

Other: Thermoregulation bundle

CONTROL GROUP

OTHER

Newborns in this group will receive routine delivery room care according to the standard hospital protocol. No structured thermoregulation bundle will be applied.

Other: routine care

Interventions

Thermoregulation bundle OTHER

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.

THERMOREGULATION BUNDLE GROUP

routine care OTHER

Standard delivery room care according to institutional protocol.

CONTROL GROUP

Eligibility Criteria

• Age: 2 Hours - 2 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Kocaeli Darıca Farabi Eğitim Ve Araştırma Hastanesi

Kocaeli, darıca, 41000, Turkey (Türkiye)

RECRUITING

Study Officials

• gülçin bozkurt, Professor Doctor

  istanbul üniversitesi cerrahpaşa sağlık bilimleri fakültesi

  STUDY DIRECTOR

Central Study Contacts

yeşim dilki, student

CONTACT

+905010732834; yesimdilki@ogr.iuc.edu.tr

gülçin bozkurt, Professor Doctor

CONTACT

+905336349093; gbozkurt@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention (thermoregulation bundle applied immediately after birth), blinding of participants, care providers, and outcome assessors is not feasible. Therefore, the study is conducted as open-label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: study director

Model Details: Participants will be randomly assigned to either the thermoregulation bundle group or the routine care group in a parallel design. The intervention will be applied immediately after birth during the first hour of life. Outcomes will be compared between groups.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 5, 2026
• Study Start: November 1, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)