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 @ 4:24 AM
Ignite Modification Date:
2025-12-25 @ 4:24 AM
NCT ID:
NCT02701920
Eligibility Criteria:
Inclusion Criteria:
* Written consent from the mother
* Realistic prospect of survival as determined by the attending clinical team
Phase 1:
\- Infants on NICU
Phase 2:
\- Infants on NICU requiring heart rate monitoring
Phase 3:
\- Newborn infants following non-emergency elective cesarean section
Phase 4:
\- Newborn infants who attending clinical team anticipate will require assessment of heart rate at time of birth
Feedback:
* Mothers of babies recruited into HeartLight study
* Healthcare professionals exposed to the new device
Exclusion Criteria:
Phase 1+2:
* Infants undergoing palliative care
* Infants too sick to tolerate additional procedures
Phase 3:
* Abnormal antenatal scans suggesting significant fetal abnormality (by definition these are not routine pregnancies).
* Any infant in whom resuscitation is likely to be required.
* If multiple births then only the first baby born shall be recruited (due to resource limitations with researchers attending the birth)
Phase 4:
* Infants \<23 weeks
* Infants that are not for active resuscitation as decided by the clinical team
* If multiple births then only the first baby born shall be recruited (due to resource limitations with researchers attending the birth)
Feedback:
Unable to obtain written informed consent
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
4 Months
Study:
NCT02701920
Study Brief:
Protocol Section:
NCT02701920