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Preterm Infants Physiological Parameters and Sleep-Wakefulness Status

NCT05673213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-01-09

No results posted yet for this study

Summary

This research was carried out between December 2021 and May 2022 as a randomized controlled experimental design. In the study, between 28-35 weeks of gestation preterm infants were divided into two groups as the experimental group (n=30) and the control group (n=30). The block randomization method was used to ensure that the infants were similar in terms of both weeks and weight due to the large interval between the weeks and to ensure the balance between the groups. Infants in the control group were followed in the routine prone position of the neonatal intensive care unit, while infants in the experimental group were followed in the prone position with three-stair positioning pillows.

Conditions

  • Sleep

Interventions

OTHER

Three-stair positioning pillows group

The infant was cared for, fed and treated by the primary nurse responsible for the infant between 08:30 and 08:55. No intervention was made to the preterm infant between 09:00-12:00 and the infant was allowed to rest. Preterm infants were followed for 3 hours (09:00-12:00) with three-stair positioning pillows. Between these hours, the oxygen saturation and heart rate of the preterm infants in were counted by the researcher with a pulse oximeter device and recorded 18 times in 10 minutes. Sleep-wakefulness status was recorded by taking 15-second recordings with the Actigraphy measuring device.

Sponsors & Collaborators

  • Harran University

    lead OTHER

Principal Investigators

  • Fatma BOZDAĞ, Lecturer · Harran University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
35 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-03-15
Completion
2022-05-28

Countries

  • Turkey (Türkiye)

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05673213 on ClinicalTrials.gov