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Sleep-wakefulness Status in Preterm Infants

Comparison of the Effects of Three Stair Positioning Pillows and Positioning Materials on the Sleep-Wakefulness Status of Preterm Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06664749
Enrollment
60
Registered
2024-10-29
Start date
2023-02-05
Completion date
2023-12-20
Last updated
2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

preterm, infants, neonatal intensive care unit

Brief summary

This study was conducted to compare the effectiveness of three stair positioning pillows and positioning materials on the sleep-wakefulness status of preterm infants.

Detailed description

It is known that newborns have similar brain activity in the intrauterine period and REM sleep activity, and they sleep more than adults and spend most of their sleep in the REM sleep period. Therefore, sleep quality in the newborn period is directly related to healthy development. Providing a developmentally supportive position in neonatal intensive care units (NICU) is necessary not only for neuromotor and musculoskeletal development, but also for physiological function and stability, thermal regulation, bone density, neurobehavioral organization, calmness and comfort, skin integrity, optimal musculoskeletal development, facilitation of sleep, growth and brain development. Excessive noise in the NICU, prolonged bright lights, separation from the mother, frequent invasive procedures and pain experience are among the factors that disrupt, shorten and create stress in the sleep duration of preterm babies. It is very important to support the sleep of preterm babies in the NICU in order to improve their growth and development, especially their brain development. It is known that therapeutic positions, which are one of the individualized developmental care practices, are effective on sleep.This study was conducted to compare the effectiveness of three stair positioning pillows and positioning materials on the sleep-wakefulness status of preterm infants.

Interventions

OTHERThree stair position pillow group

Preterm infants were monitored with three stair position pillows.

OTHERPositioning material group

Preterm infants were monitored with positioning material pillows.

Sponsors

Harran University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
30 Weeks to 34 Weeks
Healthy volunteers
Yes

Inclusion criteria

* Preterm infants who were postmenstrual age ≥30 and ≤34, * had an appropriate weight for gestational age (AGA), * were spontaneously breathing (extubated and not receiving any oxygen support), * had no history of previous intubation, routinely had caffeine in their diet, and * whose parents volunteered to participate in the study were included in the study.

Exclusion criteria

* Preterm infants who were \<30 and \>34 years postmenstrual, * had bradycardia, * received an analgesic 4 hours before that could affect sleep, * had sepsis, * congenital anomalies, * intracranial hemorrhage, * hyperbilirubinemia, * hypoglycemia, * underwent surgery, * received any oxygen support, or were on mechanical ventilation were excluded from the study.

Design outcomes

Primary

MeasureTime frameDescription
Sleep3 hoursMeasured with an actigraphy device. Unit is minutes.
wakefulness3 hoursMeasured with an actigraphy device. Unit is minutes.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026