Swaddling versus nesting to reduce pain and stress in newborns on nasal CPAP

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, two-arm trial will enroll 100 newborns receiving nasal CPAP for transient tachypnea in a single NICU and assign them to either swaddling or nesting. Researchers will monitor heart rate, respiratory rate, oxygen saturation, and pain/stress signs using the ALPS-Neo scale while maintaining controlled environmental conditions. A painless saliva sample will be taken to measure stress biomarkers and measurements will be recorded before and after the assigned comfort intervention. The interventions are routine, noninvasive positioning techniques applied by trained staff and parents will provide consent prior to participation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Birth week greater than 35 weeks and birth weight greater than 2000 grams
* Requirement for nasal CPAP/noninvasive mechanical ventilation
* Legal guardians' consent to participate in the study
* Postnatal diagnosis of transient tachypnea of the newborn

Exclusion Criteria:

Mother:

* Taking cortisol-containing medication during the antenatal period
* Taking narcotics during the antenatal period
* Having chorioamnionitis
* Having a metabolic disorder (adrenal insufficiency, etc.)

Newborn:

* Amniotic fluid stained with meconium
* Being intubated
* Having an Apgar score below 6
* Receiving analgesic or narcotic drugs for sedation
* The newborn receiving cortisol-containing medication
* Being unable to obtain a saliva sample or the sample being contaminated with blood
* Signs of nasal injury during noninvasive mechanical ventilation
* Congenital defects (spina bifida, gastroschisis, etc.) that prevent positioning using the swaddling or cradling methods
* Resuscitation
* Cerebral hypoxia-ischemia
* Non-respiratory causes (congenital pneumonia, respiratory distress syndrome, congenital heart disease, hypocalcemia, persistent hypoglycemia, development of sepsis)
* Hypocalcemia (low calcium level detected in blood gas sample taken while establishing an intravenous line prior to nCPAP)

Where it's running

• Kütahya Health Sciences University
  Merkez, Kütahya, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Canan Sümeyra Özyurt, Asist. Prof. Dr., PHD
• Email: canansumeyra.gun@ksbu.edu.tr
• Phone: 05458125720

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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.