Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

List	Outcome	Time frame	Description
Primary	Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life	24 hours of life	Optimal mean blood pressure (OMBP) will be defined as either a 10% increase in mean blood pressure value or a 2-3 mmHg rise in mean blood pressure value AND an improvement in tissue perfusion as demonstrated by a resolution in the specified clinical symptom (designated upon enrollment) within 4-6 hours of having reached OMBP
Secondary	Heart Rate Change From Baseline	96 hours or until hypotension completely resolved and medications stopped	Heart rate change from baseline during study drug administration
Secondary	Acid-base Status	96 hours or until hypotension resolved and medication completely stopped
Secondary	Hyponatremia	96 hours or until medication completely stopped
Secondary	Urine Output	96 hours or until hypotension resolved and medication completely stopped
Secondary	Evidence of Ischemic Changes	96 hours or until medication completely stopped	Physical examinations were done on at least a twice daily basis to evaluate for any ischemic lesions (especially on the limbs) of all subjects. The presence of any lesion considered to be due to ischemia would have been reported in this data.
Secondary	Necrotizing Enterocolitis	until hospital discharge, up to 12 weeks
Secondary	Ventilator Days	Until hospital discharge, up to 15 months
Secondary	Presence of Patent Ductus Arteriosus (PDA)	until hospital discharge, up to 12 weeks
Secondary	Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound	Until hospital discharge, up to 15 months
Secondary	Retinopathy of Prematurity Stage 3 or Higher	Until hospital discharge, up to 15 months	All subjects were followed by an ophthalmologist with initial exam at 4-6 weeks of age. The Stages describe the ophthalmoscopic findings at the junction between the vascularized and avascular retina. Each subject is followed until cleared by ophthalmology. For this outcome measure, the most severe stage of disease was used in analysis. Stage 1 is a faint demarcation line. Stage 2 is an elevated ridge. Stage 3 is extraretinal fibrovascular proliferation (neovascularization). Stage 4 is sub-total retinal detachment. Stage 5 is total retinal detachment. Stages 1 and 2 do not lead to blindness. However, they can progress to the more severe stages.
Secondary	Presence of Bronchopulmonary Dysplasia (BPD)	36 weeks postmenstrual age	Infants were evaluated for oxygen need at 36 weeks postmenstrual age. If they required supplemental oxygen, they were diagnosed with BPD
Secondary	All Cause Mortality	admission to hospital discharge, up to 15 months

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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