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NCT07865897
Elevated Midline Positioning During Diaper Change in Preterm Infants
Conditions: Infant, Premature, Diseases, Premature Birth of Newborn, Pain
Sex: All
Ages: 4 Days – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Akdeniz University
Summary
Diaper changing is one of the most frequent routine care procedures in the neonatal intensive care unit (NICU) and is known to cause physiological instability and behavioral stress responses in preterm infants. During a conventional diaper change the infant is often kept in a side-lying position with the head turned to one side, which may impair jugular venous drainage. In contrast, 30-degree head-of-bed elevation with the head kept in the midline has been shown to lower intracranial pressure and is a core component of intraventricular hemorrhage prevention care bundles. No randomized controlled trial has yet examined the effect of this position during diaper change.
The purpose of this randomized controlled trial is to determine whether 30-degree elevated midline positioning during a routine diaper change, compared with standard care (diaper change in a flat, side-lying position), reduces oxygen desaturation and bradycardia episodes, lowers pain/stress scores measured with the Neonatal Infant Pain Scale (NIPS), and shortens the time needed for heart rate and oxygen saturation to return to baseline in stable preterm infants born at 28-34 weeks of gestation.
Eighty infants (40 per group) in the level III NICU of Antalya City Hospital, Türkiye, will be randomly assigned to one of the two groups. Each infant will be evaluated during a single diaper change performed after 96 hours of postnatal age.
Eligibility Criteria
Inclusion Criteria:
* Born between 28 and 34 weeks of gestation
* Hemodynamically stable (not requiring inotropic support)
* Not receiving invasive mechanical ventilation (infants on room air, CPAP or high-flow nasal cannula may be included)
* Continuous SpO2 and heart rate monitoring in place
* Completion of at least the first 72-96 hours of postnatal life (the study procedure is not performed before 96 hours of postnatal age)
* Written informed consent obtained from a parent
Exclusion Criteria:
* Receiving invasive mechanical ventilation
* Major congenital or chromosomal anomaly
* Previously diagnosed grade III-IV intraventricular hemorrhage or other significant intracranial pathology
* Hemodynamic instability requiring inotropic support
* Surgical or orthopedic conditions in which positioning is contraindicated, or skin integrity problems
* Analgesic or sedative medication administered within the 6 hours before the procedure
* Withdrawal of parental consent at any stage
Source: ClinicalTrials.gov (NCT07865897). StuddyBuddy aggregates publicly available trial information.