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Sleep-wakefulness Status in Preterm Infants

H

Harran University

Status

Completed

Conditions

Sleep

Treatments

Other: Positioning material group
Other: Three stair position pillow group

Study type

Interventional

Funder types

Other

Identifiers

NCT06664749
HRU-BOZDAG-003

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

30 to 34 weeks old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Three stair position pillow group
Experimental group
Description:
Three stair position pillows were used for preterm infants.
Treatment:
Other: Three stair position pillow group
Positioning material group
Experimental group
Description:
Positioning materials were used for preterm infants.
Treatment:
Other: Positioning material group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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