Swaddling and Facilitated Tucking During Nasal CPAP in Newborns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial will compare three groups of newborns on nasal CPAP: fetal position, swaddling, and usual care. Data will be collected using standardized pain and stress scales and physiological measures in the NICU at Recep Tayyip Erdogan University between May and December 2026. Enrollment targets 114 newborns (38 per experimental group and 38 controls) with an additional 10% reserve, and randomization will be performed online. The study aims to determine if positioning strategies during CPAP can improve comfort and reduce stress without introducing safety concerns. Ethics approval will be obtained and trial registration completed after approval.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Those receiving nasal CPAP support,
* Newborns between 34 0/7 weeks and 36 6/7 weeks of gestation,
* Those without congenital anomalies,
* Those without a health problem that prevents positioning,
* Those without mental or neurological problems.

Exclusion Criteria:

* Those with pneumothorax,
* Newborns who received opioids or sedatives 4 hours before the procedure,
* Intubated newborns
* Newborns with a gestational age greater than 37 weeks

Where it's running

• Recep Tayyip Erdogan University
  Rize, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Gamzegül ALTAY, PhD
• Email: gamzegulaltay25@gmail.com
• Phone: +905456119296

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.