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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT04007120
Eligibility Criteria:
Inclusion Criteria:
* Preterm infants between 32 weeks 0 days and 34 weeks 6 days of PMA
* Born between 24 weeks 0 days and 29 weeks 6 days of estimated GA
* Requiring minimal or no respiratory support (i.e., supplemental oxygen with \<2 liters per minute of nasal cannula flow acceptable)
* Body weight appropriate for gestational age
* Written informed consent obtained from at least one of the parents or legal guardians
Exclusion Criteria:
* Requiring invasive or noninvasive respiratory support (e.g., mechanical ventilation, CPAP)
* Clinically unstable (i.e. unable to maintain SpO2 between 90-95 % , escalating respiratory support in the past 24 hours)
* Major congenital anomaly (chromosomal, renal, cardiac, hepatic, neurologic or pulmonary malformations)
* Significant cardiac disorder (i.e., pulmonary hypertension)
* History of major surgical procedure
* Any condition that would preclude receiving study drug or performing any study-related procedures
* Participation in any other investigational drug study
* History of hypersensitivity or intolerance to cromolyn sodium
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
32 Months
Maximum Age:
35 Months
Study:
NCT04007120
Study Brief:
Protocol Section:
NCT04007120