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 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT01643057
Eligibility Criteria:
Inclusion Criteria:
Eligible subjects are infants currently inpatient in the NICU at Beth Israel Deaconess Medical Center and:
* Born premature, at a gestational age \< 36 weeks
* Demonstrate irregular breathing by having had at least one documented clinical apnea (\> 20 seconds), bradycardia (\< 100 bpm) and/or desaturation (\< 90%)
Exclusion Criteria:
Eligible infants meeting the inclusion criteria above will be excluded from participation in the study if he/she:
* Is at a Post Conceptual Age of \> 45 weeks at time of study (Calculated as: weeks of age at birth + weeks of age since birth)
* Has demonstrable pulmonary disease at time of study, i.e. Chronic Lung Disease, Infant Respiratory Distress Syndrome
* Has Hypoxic-Ischemic Encephalopathy including a cord pH of ≤ 7
* Has a congenital abnormality
* Has a genetic syndrome
* Has an anatomic brain anomaly
* Has hydrocephalus or intraventricular hemorrhage \> Grade 3 or 4
* Is anemic (hemoglobin \< 8g/dL)
* Has an infection at time of study
* Is undergoing therapeutic hypothermia
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01643057
Study Brief:
Protocol Section:
NCT01643057