Thermoregulation bundle at birth to help newborns keep warm and start breastfeeding
Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 2 Hours to 2 Hours |
| Sex | All |
| Sponsor | Istanbul University - Cerrahpasa Academic / other |
| Locations | 1 site (Kocaeli, darıca) |
| Trial ID | NCT07453264 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Kocaeli, darıca
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.