Maternal Odor as a Developmental Care Intervention for Apnea of Prematurity (NCT07689669) | Clinical Trial Compass
CompletedNot Applicable
Maternal Odor as a Developmental Care Intervention for Apnea of Prematurity
Turkey (Türkiye)60 participantsStarted 2022-11-01
Plain-language summary
Apnea of prematurity is one of the most common complications in preterm infants hospitalized in neonatal intensive care units. This randomized controlled trial was conducted to evaluate the effect of maternal odor exposure as a developmental care intervention on apnea frequency, physiological parameters, and growth outcomes in preterm infants. Sixty preterm infants were randomly assigned to either a maternal odor intervention group or a routine care control group. The intervention group received maternal odor using a cotton cloth carrying the mother's natural scent for five consecutive days. The primary outcome was the daily number of apnea episodes. Secondary outcomes included oxygen saturation, heart rate, respiratory rate, body temperature, weight, and head circumference.
Who can participate
Age range
5 Days – 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:
* Preterm infants born between 26 and 37 weeks of gestation
* Birth weight between 1000 and 2500 g
* Hospitalized in the neonatal intensive care unit for at least 5 days
* Receiving oral or enteral feeding
* Written informed consent obtained from parent(s) or legal guardian(s)
Exclusion Criteria:
* Endotracheal intubation, mechanical ventilation, or nasal continuous positive airway pressure
* Receiving oxygen therapy
* Congenital heart disease
* Suspected or confirmed sepsis
* Intracranial hemorrhage
* Receiving analgesic, sedative, or muscle relaxant therapy
* Previous surgical procedure
* Development of a medical condition requiring withdrawal from the study or hospitalization for less than 5 days
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.