CompletedNot Applicable

Effect of a Bathing Care Package on Comfort and Skin Moisture in Preterm Infants in a Neonatal Intensive Care Unit

Turkey (Türkiye)64 participantsStarted 2024-11-15

Plain-language summary

This completed study evaluated the effects of a bathing care package on the comfort level and skin hydration of preterm infants admitted to the neonatal intensive care unit (NICU). Preterm infants, born before 37 weeks of gestation, often experience skin dryness and discomfort due to their immature skin barrier. The bathing care package involved a gentle bathing procedure using warm water at a specific temperature, performed in a basin with a wrapping technique. This procedure was carried out under controlled room temperature and humidity conditions to maximize infant comfort. Comfort-enhancing techniques were also applied during and after the bath. Preterm infants were randomly assigned to either the intervention group receiving the bathing care package or the control group receiving the standard bathing care routinely practiced in the NICU. Data collected throughout the study demonstrated that the bathing care package helped maintain skin hydration and preserve comfort levels better than the standard care. The findings contribute to improving neonatal nursing protocols aimed at enhancing the well-being of preterm infants. All procedures were conducted with informed consent from parents or legal guardians and approved by the institutional ethics committee.

Who can participate

Age range

32 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: * Parental consent to participate in the study * Gestational age between 32 and 37 weeks * Admission to the Neonatal Intensive Care Unit * Spontaneous breathing * Stable physiological parameters * Birth weight above 1500 g * 24 hours have passed since birth (WHO) Exclusion Criteria: * Birth weight below 1500 g * Dependence on mechanical ventilation * Diagnosed with sepsis * Receiving sedatives and/or muscle relaxants * Chromosomal abnormality * Infant of a mother with hepatitis or HIV * Meconium aspiration * Chest tube, central venous catheter, drain, peritoneal dialysis catheter.

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

Neonatal comfort score

Timeframe: Before bath, and at 15 and 30 minutes after bath

Skin moisture level

Timeframe: Before bath, and at 15 and 30 minutes after bath

Trial details

NCT IDNCT07068737

SponsorKiymet Aygün

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-04

View on ClinicalTrials.gov More Preterm Birth trials