Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07865897 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Elevated Midline Positioning During Diaper Change in Preterm Infants

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Study description shortened, about 45 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07865897
Lead Sponsor Akdeniz University
Conditions
(from sponsor)
Infant, Premature, Diseases, Premature Birth of Newborn, Pain
Related terms Bradycardia, Infant, Premature, Diseases, Pain, Premature Birth
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov