CompletedNot Applicable

Comparison Three Methods on Endotracheal Aspiration in Preterm Infants

Turkey (Türkiye)100 participantsStarted 2024-02-03

Plain-language summary

Stress and pain control are vital for newborns, especially preterm babies. While painful procedures cause physiological changes in the short term, they negatively affect brain development in the long term. Non-pharmacological interventions with proven efficacy include: fetal position, sucrose, breastfeeding, breast milk, maternal presence, non-nutritive sucking, swaddling (wrapping) and skin-to-skin contact, as well as developmentally supportive positioning. Evaluating the effectiveness of nursing practices to be performed on babies, scientifically proving the most beneficial application that will both alleviate pain and increase their comfort in painful procedures such as aspiration and being more beneficial to babies are among the most basic benefits. Thanks to these applications, it is predicted that your baby will experience less pain and provide more comfort. Therefore, this study aim to comparison the effects of facilitated tucking, swaddling and prone position applied during endotracheal aspiration on pain, comfort and physiological parameters in preterm infants.

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: * Having 28-35 weeks of gestation, * Follow-up as intubated in SIMV mode on mechanical ventilator, * Follow-up on a ventilator between 1-10 days, * Having a body weight of ≥1000 g, * Those who have not taken any opioid or sedative medication until 4 hours before the procedure will be included. Exclusion Criteria: * Presence of congenital anomaly, * Chest tube inserted * Intracranial bleeding, * Presence of condition/anomaly that will prevent prone tilting, * Those with a history of epileptic seizures will be excluded.

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

Pain scores

Timeframe: 6 minutes

Comfort score

Timeframe: 6 minutes

physiological parameter (Heart rate)

Timeframe: 6 minutes

physiological parameter (oxygen saturation)

Timeframe: 6 minutes

Trial details

NCT IDNCT05434364

SponsorIstanbul University - Cerrahpasa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-03

View on ClinicalTrials.gov More Preterm 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.