The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant P… (NCT03939169) | Clinical Trial Compass
TerminatedNot Applicable
The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP)
Stopped: Change in Principal Investigator Role
France4 participantsStarted 2019-11-15
Plain-language summary
Out of the most commonly performed procedures in neonates, naso-gastric tube insertion is rated as the fifth most painful. The pain is often under estimated due to the frequency with which the procedure is carried out. It has been shown that the environment in which the procedure is performed (e.g with skin to skin contact and specific positioning), reduces the discomfort felt by the newborn. However, this has not yet been proven with regards to naso-gastric tube insertion.
Who can participate
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 baby born between the 32th and the 35th weeks of amenorrhea plus 6 days
* Prescription of enteral nutrition via naso-gastric tube
* Naso-gastric tube in-situ
* Informed consent of both parents
Exclusion Criteria:
For the newborn
* Under respiratory assistance
* With nasal or buccal malformation
* With abnormal heart rhythm or congenital heart disease
* With hemodynamic instability
* Transfer to type 3 neonatal unit
* With a DAN score \> 0 before treatment
* With an umbilical venous catheter in-situ
* Fed with thickened milk
* Prescription of analgesic medications
For the parents
* Minor
* Under legal protection
* Difficulties which do not permit the mother to carry out skin-to skin contact or holding support
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.