CompletedNot Applicable

Evaluation of Cerebral Oxygenation Results in Premature Infant

Turkey (Türkiye)106 participantsStarted 2020-12-20

Plain-language summary

The general purpose of this project is; Evaluation of cerebral oxygenation results in premature infants. These results will be evaluated in two different applications. The first practice and the first sub-aim of the study is to determine the effect of kangaroo care on cerebral oxygenation (rSO2) in premature infants. The second application and purpose is to determine the effect of giving the infant the facilitated tucking position by hand and the nesting bed on the cerebral oxygenation (rSO2) of the infant during the heel blood collection process. The study will be conducted between December 2020 and December 2021 at Level III NICU at the Medical Faculty Hospital in Konya.

Who can participate

Age range

24 Weeks – 37 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: * Adjusted gestational age of 28-36(+6) weeks at time of registration Exclusion Criteria: * Mechanical ventilation, * Major congenital abnormalities, * Surgical or severe medical morbidity (bronchopulmonary dysplasia, NEC, sepsis, or intraventricular bleeding) * The mother is under 18 years of age * The mother is not willing to do kangaroo care

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

The first sub-purpose Outcome: rSO2 level

Timeframe: Change from baseline and 70 min

The first sub-purpose Outcome: physiological parameters of the premature infant- heart rate (min).

Timeframe: Change from baseline and 70 min

The first sub-purpose Outcome: physiological parameters of the premature infant- SpO2 level

Timeframe: Change from baseline and 70 min

The first sub-purpose Outcome: Neonates COMFORTneo scale

Timeframe: Change from baseline and 70 min

The first sub-purpose Outcome: physiological parameters of the premature infant-respiratory rate (min)

Timeframe: Change from baseline and 70 min

Trial details

NCT IDNCT04725435

SponsorSelcuk University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-20

View on ClinicalTrials.gov More Cerebral Oxygenation trials

Plain-language summary

Who can participate

Age range

24 Weeks – 37 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.

What they're measuring

The first sub-purpose Outcome: rSO2 level

Timeframe: Change from baseline and 70 min

The first sub-purpose Outcome: physiological parameters of the premature infant- heart rate (min).

Timeframe: Change from baseline and 70 min

The first sub-purpose Outcome: physiological parameters of the premature infant- SpO2 level

Timeframe: Change from baseline and 70 min

The first sub-purpose Outcome: Neonates COMFORTneo scale

Timeframe: Change from baseline and 70 min

The first sub-purpose Outcome: physiological parameters of the premature infant-respiratory rate (min)

Timeframe: Change from baseline and 70 min