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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT01954056
Eligibility Criteria:
Inclusion Criteria:
* Gestational age greater than or equal to 34 weeks at birth
* Admitted to the center NICU by 48 hours of age
* Intubated and mechanically ventilated for a minimum of 2 hours before 72 hours postnatal age
Exclusion Criteria:
* Receiving ECMO
* Intubated for the sole purpose of anticipated surgery or airway anomalies
* Treatment will be limited based on poor prognosis
* Receiving dexamethasone or hydrocortisone
* Receiving ibuprofen or indomethacin
* Congenital heart disease
* Hypotension thought to result from specific, immediately remediable factors including placental hemorrhage, acute hemorrhage or tension pneumothorax
* Pituitary hypoplasia or congenital adrenal hyperplasia
* Any chromosomal disorder
* Hypertension in the absence of inotrope therapy as defined by mean arterial blood pressure \> 95th percentile
* Initiation of whole body cooling for moderate or severe neonatal encephalopathy
* Brain disorders or any other known structural abnormality
* Major anomalies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
34 Weeks
Study:
NCT01954056
Study Brief:
Protocol Section:
NCT01954056