Effects of a Valved Feeding System in Late-preterm Newborns: the Safe Oral Feeding Trial (NCT04400175) | Clinical Trial Compass
CompletedNot Applicable
Effects of a Valved Feeding System in Late-preterm Newborns: the Safe Oral Feeding Trial
Italy40 participantsStarted 2020-12-01
Plain-language summary
Comparing with a randomized controlled trial two different feeding systems in two groups of late-preterm newborns for evaluating which is more efficient in promoting the coordination in the process of sucking-swallowing-breathing and better cardiorespiratory stability.
The B-ESP group will be fed with a feeding system with a valved ergonomic teat; the B-STD with a standard feeding system.
Who can participate
Age range
1 Day – 5 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:
* Gestational age 34+0 - 36+6 weeks at birth;
* Exclusive oral feeding;
* Bottle-feeding for at least a meal a day;
Exclusion Criteria:
* Newborns with exclusive breastfeeding;
* Newborns with congenital anomalies, perinatal asphyxia, respiratory or neurological issues, genetic syndromes, infections, metabolic diseases;
* Ongoing administration of medication able to interfere with esophageal or respiratory function;
* Newborns who require respiratory support, including oxygen-therapy via nasal-cannula;
* Newborns who require oral or nasal feeding tube;
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
Evaluating the level of coordination in the sucking-swallowing-breathing pattern in the B-ESP group compared with the B-STD