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

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 Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Other: Three stair position pillow group; Other: Positioning material group

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Şanlıurfa, Turkey, 633000
    • Fatma Bozdağ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Three stair position pillow group; Three stair position pillows were used for preterm infants.	Other: Three stair position pillow group; Preterm infants were monitored with three stair position pillows.
Experimental: Positioning material group; Positioning materials were used for preterm infants.	Other: Positioning material group; Preterm infants were monitored with positioning material pillows.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep	Measured with an actigraphy device. Unit is minutes.	3 hours
wakefulness	Measured with an actigraphy device. Unit is minutes.	3 hours

Collaborators and Investigators

• Sponsor: Harran University
• Investigators: Principal Investigator: fatma bozdağ, Harran University

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2023
• Primary Completion (Actual): July 17, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: October 26, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: preterm; infants; neonatal intensive care unit
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: HRU-BOZDAG-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No