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 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT02747069
Eligibility Criteria:
Inclusion Criteria:
* All must have written informed consent from the participant's mother
* Phase 1: Any neonate requiring NICU admission and routine monitoring with ECG.
* Phase 2: Preterm infants ≤32 weeks gestation delivered into a plastic bag/wrap
Exclusion Criteria:
* Phase 1: Infants undergoing comfort care (palliative care). Infants deemed too sick, as assessed by the clinical team caring for them, to tolerate additional procedures. This is unusual but would normally include infants who become more unstable with increased handling
* Phase 2: Infants \>32 weeks gestation Infants where resuscitation is unlikely to be instigated (eg. known lethal condition)
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
4 Months
Study:
NCT02747069
Study Brief:
Protocol Section:
NCT02747069