Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants (NCT02508571) | Clinical Trial Compass
CompletedNot Applicable
Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants
South Korea189 participantsStarted 2015-07
Plain-language summary
This is randomized controlled trial investigating the effects of direct swallowing training and oral sensorimotor stimulation in preterm infants on oral feeding performance.
Who can participate
Age range
22 Weeks – 31 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:
* Preterm infants : before 32+0 weeks gestation
* Infants who are receiving full tube feeding (more than 120 ml/kg/day)
* Infants who discontinue of nasal continuous positive airway pressure before postmenstrual age 33+0 weeks
* 'Feeders and growers'
* The parents of the subject voluntarily sign the informed consent
Exclusion Criteria:
* Major congenital anomalies : face, central nervous system, gastrointestine, heart, etc
* Gastrointestinal complications
* Chronic medical complications : Intraventricular hemorrhage ≥ Grade III, periventricular leukomalacia, surgical necrotizing enterocolitis
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
1
Days From Start to Independent Oral Feeding
Timeframe: From date of starting oral feeding until the date of independent, full oral feeding, an expected average of 3 weeks