CompletedNot Applicable

Sleep-wakefulness Status in Preterm Infants

Turkey (Türkiye)60 participantsStarted 2023-02-05

Plain-language 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.

Who can participate

Age range

30 Weeks – 34 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: * 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.

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

Timeframe: 3 hours

wakefulness

Timeframe: 3 hours

Trial details

NCT IDNCT06664749

SponsorHarran University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-17

View on ClinicalTrials.gov More Sleep trials

Who can participate

Age range

30 Weeks – 34 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.