CompletedNot Applicable

Non-Nutritive Sucking vs Non-Nutritive Sucking Combined With Breast Milk on the Neonatal Comfort

Turkey (Türkiye)30 participantsStarted 2021-11-01

Plain-language summary

The aim of the study is to determine the effect of the use of non-nutritive sucking vs non-nutritive sucking combined with breast milk on neonatal comfort during diaper change in preterm infants.

Who can participate

Age range

1 Day – 28 Days

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: * The preterm infants whose parents agree to participate in the research and sign the informed consent form; * Who have no congenital anomaly; * Who have no chronic disease; * Who have undergone no surgical procedure; * Who have no neurological symptoms; * Who have no NEC (necrotizing enterocolitis) diagnosis; * Who are not sedated; * Who are not hypoglycemic; * Who have been administered no pharmacological analgesic method 4 hours before; * Who are born between ≥28 and ≤36+6 gestation weeks, or are in between ≥28 and ≤36+6 gestation weeks during the procedure. Exclusion Criteria: * The infants whose parents do not agree to participate in the research and do not sign the informed consent form; * Who have a congenital anomaly; * Who have a chronic disease; * Who had undergone a surgical procedure; * Who have neurological symptoms; * Who have NEC (necrotizing enterocolitis) diagnosis; * Who are sedated; * Who are hypoglycemic; * Who have been administered no pharmacological analgesic method 4 hours prior; * Who were between \<28 and \>36+6 gestation weeks.

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

Change in Comfort Level

Timeframe: 5 minutes before, immediately before, during, immediately after, and 5 minutes after the procedure.The change in these time intervals will be assessed.

Trial details

NCT IDNCT05097495

SponsorAcibadem University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-23

View on ClinicalTrials.gov More Infant, Premature trials

Who can participate

Age range

1 Day – 28 Days

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.