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

The Effect of Swaddling and Nesting Methods on Pain and Stress Levels in Newborns Undergoing Noninvasive Mechanical Ventilation

This study will test whether swaddling or nesting helps reduce pain and stress in newborns who are receiving nasal CPAP (noninvasive breathing support).

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 0 Days to 28 Days
• Sex: All
• Sponsor: Kutahya Health Sciences University (Academic / other)
• Locations: 1 site (Merkez, Kütahya)
• Trial ID: NCT07335263 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Newborns born at ≥35 weeks gestation, weighing >2000 g, diagnosed with transient tachypnea and receiving nasal CPAP in the NICU whose legal guardians provide consent are eligible.

Not a fit: Infants who are intubated, have congenital defects that prevent swaddling or nesting, have nasal injury, are receiving systemic analgesics or narcotics, or cannot provide an uncontaminated saliva sample may not benefit or be eligible.

Why it matters

Potential benefit: If successful, one of these simple positioning methods could lower pain and stress during respiratory support and improve short-term comfort and physiological stability for newborns.

How similar studies have performed: Previous small or observational studies and routine clinical experience suggest swaddling and nesting can reduce behavioral and physiological signs of stress in newborns, but randomized comparisons in infants on nCPAP are limited.

Eligibility criteria

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 this trial is running

Merkez, Kütahya

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

Study contacts

• Study coordinator: Canan Sümeyra Özyurt, Asist. Prof. Dr., PHD

Conditions Stress; Non Pharmacological Intervention; Newborn Diseases