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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT04368767
Eligibility Criteria:
Inclusion Criteria:
* Infants between 34 weeks and 0/7 days through 35 weeks and 6/7 days gestational age
* Medically stable as determined by a Neonatal Acute Physiology- Perinatal Extension SNAPPE -II (SNAPPE-II) score of less than 9
* Mothers able to read and write English
* Mothers have no medical contraindications to holding their infant in SSC for up to 2 hours
Exclusion Criteria:
* Surgery in the first week of life
* Intraventricular hemorrhage (IVH) of grade 3 or 4
* Opioids, benzodiazepines, muscle relaxants, phenobarbital, and/or dilantin
* Plasma creatinine of \>1 mg/dl
* Severe cyanotic heart disease or severe respiratory distress
* Abdominal wall or intestinal anomaly or injury (NEC)
* Facial anomaly or other known chromosomal anomaly
* Life-threatening congenital anomaly or are so critically ill that they are unlikely to survive or are receiving palliative care
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT04368767
Study Brief:
Protocol Section:
NCT04368767