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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2023
CompletedFirst Submitted
Initial submission to the registry
October 26, 2024
CompletedFirst Posted
Study publicly available on registry
October 29, 2024
CompletedOctober 29, 2024
October 1, 2024
5 months
October 26, 2024
October 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Sleep
Measured with an actigraphy device. Unit is minutes.
3 hours
wakefulness
Measured with an actigraphy device. Unit is minutes.
3 hours
Study Arms (2)
Three stair position pillow group
EXPERIMENTALThree stair position pillows were used for preterm infants.
Positioning material group
EXPERIMENTALPositioning materials were used for preterm infants.
Interventions
Preterm infants were monitored with three stair position pillows.
Preterm infants were monitored with positioning material pillows.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fatma Bozdağ
Sanliurfa, 633000, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
fatma bozdağ
Harran University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 26, 2024
First Posted
October 29, 2024
Study Start
February 5, 2023
Primary Completion
July 17, 2023
Study Completion
December 20, 2023
Last Updated
October 29, 2024
Record last verified: 2024-10