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:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT05175560
Eligibility Criteria:
Inclusion Criteria:
Parents or caregivers :
* Have a baby aged \>3 weeks to \~3-4 months (who is not yet able to role over; see exclusion criteria);
* Have a baby who sleeps in its own bed (i.e. different sleeping surface than parents; same room is allowed);
* Live in the Netherlands;.
* Are able to speak and read Dutch or English.
Exclusion Criteria:
Parents or caregivers
* with a baby who can already roll over (belly to back and back to belly);
* with a baby who is under supervision of an HCP because of health, feeding or developmental problems ;
* are unwilling or unable to provide informed consent on behalf of themselves, their baby and siblings;
* are unwilling or unable to comply with the study requirements;
* do not give permission to use their, or that of potential siblings, audio-video image data recorded during the study as described in the information letter and privacy notice;
* are not able to fill in the questionnaires and baby sleep diary.
Sex:
ALL
Minimum Age:
3 Weeks
Maximum Age:
4 Months
Study:
NCT05175560
Study Brief:
Protocol Section:
NCT05175560