Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT03939169
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03939169
Study Brief:
Protocol Section:
NCT03939169