Sleep-wakefulness Status in Preterm Infants

Not Applicable

Completed

• Conditions: Sleep

• Registration Number: NCT06664749
• Lead Sponsor: Harran University

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.

Study Timeline

• Study Start: 2023-02-05
• Primary Completion: 2023-07-17
• Study Completion: 2023-12-20
• Status Verified: 2024-10
• Study First Submitted: 2024-10-26
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sleep	3 hours	Measured with an actigraphy device. Unit is minutes.
wakefulness	3 hours	Measured with an actigraphy device. Unit is minutes.

Trial Locations

Locations (1)

Fatma Bozdağ; 🇹🇷 Şanlıurfa, Turkey