Thermoregulation bundle at birth to help newborns keep warm and start breastfeeding
Official title: Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding: A Randomized Controlled Trial
Run by Istanbul University - Cerrahpasa · NCT07453264 · Data updated 2026-11-12
This project will test whether a thermoregulation bundle applied immediately after a term vaginal birth helps newborns keep a normal body temperature and improves early breastfeeding success.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Hours to 2 Hours |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Istanbul University - Cerrahpasa Academic / other |
| Locations | 1 site (Kocaeli, darıca) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | March 30, 2026 |
| Study ends | August 30, 2026 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT07453264 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants eligible are term (38–42 weeks) singleton newborns delivered vaginally with birthweight 2500–4000 g, Apgar score ≥7 at 1 minute, and both mother and baby able to breastfeed.
✕Probably not a fit
Preterm or postterm infants, babies who require special or intensive care, those with intrauterine growth restriction or genetic disease, or infants who start formula feeding are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will apply a set of delivery-room thermoregulation measures (the bundle) to some term, singleton newborns and compare them to newborns receiving routine care. Physiological parameters including body temperature, respiratory rate, heart rate, and oxygen saturation will be recorded during the first hour after birth. Breastfeeding initiation and early breastfeeding success will also be tracked. Outcomes will be compared between the bundle and routine-care groups at a single hospital site.
Why it matters
Potential benefit: If successful, the bundle could reduce neonatal hypothermia and help more babies start and continue breastfeeding.
How similar studies have gone: Prior studies of skin-to-skin contact and specific warming measures have reduced hypothermia and supported breastfeeding, though comprehensive delivery-room thermoregulation bundles are less frequently tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Kocaeli Darıca Farabi Eğitim Ve Araştırma Hastanesi
Kocaeli, darıca, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: yeşim dilki, student
- Email: yesimdilki@ogr.iuc.edu.tr
- Phone: +905010732834
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AI-guided prediction of blood pressure changes in spinal cord injury using perfusion index during a cool-temperature test
This study tests whether perfusion index can reliably predict changes in systolic blood pressure in people with spinal cord injury during a controlled cool temperature challenge.
-
Immediate skin-to-skin contact after cesarean to support newborn heart rate variability
This project will test whether placing newborns skin-to-skin with their mothers immediately after a planned cesarean helps mothers and babies show higher heart rate variability in the first hours after birth.
-
Investigating why newborns and premature infants are prone to hypothermia
This study looks at why newborns, especially premature ones, have trouble keeping warm and tries to understand how their bodies manage temperature in different situations.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.