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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT04715451
Eligibility Criteria:
Inclusion Criteria:
* Born very preterm (\<32 weeks postmenstrual age (PMA))
* At least 12 hours and less than 2 months old
* Expected to survive \> 3 days
* No congenital anomaly or genetic disorder with expected survival less than term equivalent
* No malformations requiring surgery within 1 month of life
* Central intravenous lines removed
* Approval of the primary neonatologist, ideally not a study team member, to approach family for consent
* Appropriate parent or guardian to provide informed consent
Exclusion Criteria:
* Life expectancy \< 3 days
* Severe congenital anomaly or genetic disorder with life expectancy \<40 weeks PMA
* Seizures
* Need for seizure medication
* Hypertension for age requiring medication
* Severe hematologic crisis such as disseminated intravascular coagulation
* Hydrops fetalis
* Clinical concern or diagnosis of toxoplasmosis, cytomegalovirus rubella or syphilis infection
* Clinical concern or diagnosis of severe acute respiratory distress syndrome coronavirus 2 (SARS CoV-2) or coronavirus disease (COVID-19)
* Central intravenous access and reliance on parenteral nutrition \>50%
* Respiratory support greater than nasal canulae or nasal continuous positive airway pressure (CPAP) (i.e. ventilator dependent)
* Active infection, including need for antibiotics greater than 5 days (i.e. confirmed infection)
* Complex congenital heart disease
* Known chromosomal abnormalities
* Clinical or echocardiographic signs of symptomatic pulmonary hypertension
* Profound perinatal hypoxia-ischemia
* Receiving treatment for pain control
* Sustained tachypnea \>80 breaths/minute
* Need for volume expansion or administration of inotropes
* No one available or willing to provide consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Weeks
Maximum Age:
37 Weeks
Study:
NCT04715451
Study Brief:
Protocol Section:
NCT04715451