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 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT01852695
Eligibility Criteria:
Inclusion Criteria:
* \< 33 weeks gestational age at birth;
* On no respiratory support or low level respiratory support (i.e., oxygen by cannula or mask, or continuous positive airway pressure (CPAP);
* A primary caregiver parent who is willing and able to commit to spending at least 8 hours per day with her/his infant between the hours of 0700 and 2000;
* Parental consent.
Exclusion Criteria:
* Palliative care;
* Major life threatening congenital anomaly;
* Critical illness (unlikely to survive);
* On high level of respiratory support (mechanical ventilator, high frequency oscillatory or jet ventilation, extra-corporeal membrane oxygenation)
* Parental request for early transfer to another hospital;
* Parental inability to participate (e.g., health, social or language issues that might inhibit their ability to communicate with the healthcare team).
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
33 Weeks
Study:
NCT01852695
Study Brief:
Protocol Section:
NCT01852695