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Completed

NCT Number: NCT06664749

Sleep-wakefulness Status in 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.

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Key information

Age range

30 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fatma Bozdağ

Sanliurfa, 633000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Three stair position pillow group

Other

Preterm infants were monitored with three stair position pillows.

Positioning material group

Other

Preterm infants were monitored with positioning material pillows.

Primary outcomes

  1. Sleep

    Time frame: 3 hours

    Measured with an actigraphy device. Unit is minutes.

  2. wakefulness

    Time frame: 3 hours

    Measured with an actigraphy device. Unit is minutes.

Sponsors and collaborators

Lead sponsor

Harran University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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