CompletedNot Applicable

Preterm Infants Physiological Parameters and Sleep-Wakefulness Status

Turkey (Türkiye)60 participantsStarted 2021-12-01

Plain-language 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.

Who can participate

Age range

28 Weeks – 35 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Only being diagnosed as preterm as a result of the examination performed by the physician, * Parent's willingness to participate in the research, * The infant is between 28-35 weeks of gestation, * Being in appropriate weight according to the week of gestation, * Having a history of intubation and being extubated. Exclusion Criteria: * Surgical procedure has been applied, * Diagnosed with sepsis, * Congenital anomaly, * Taking analgesics 4 hours before, which may affect sleep, * Having hyperbilirubinemia, * Having hypoglycemia, * Presence of intracranial bleeding, * Receiving any oxygen support (nasal O2, incubator O2, etc.), * Intubated infants were not included in the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sleep Status/minute

Timeframe: 3 hours

Wakefulness Status/minute

Timeframe: 3 hours

Physiological Parameters (oxygen saturation /%)

Timeframe: 3 hours

Physiological Parameters (heart rate/minute )

Timeframe: 3 hours

Physiological Parameters (respiratory rate/minute )

Timeframe: 3 hours

Trial details

NCT IDNCT05673213

SponsorHarran University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-15

View on ClinicalTrials.gov More Sleep trials

Plain-language summary

Who can participate

Age range

28 Weeks – 35 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.