CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 820 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00882284
NCT00882284N/ACompleted

Hydrocortisone Treatment of Hypotension in Term and Late Preterm Infants: An Observational Study

NICHD Neonatal Research Network·observational·Posted Apr 16, 2009·Updated Mar 22, 2019

In Brief

An observational study for Infant, Newborn and 2 related conditions. Completed, enrolled 820 participants across 17 sites.

Detailed Summary

This observational study collects information on the current incidence and management of hypotension in babies born at term or late preterm that are admitted to Neonatal Intensive Care Units (NICUs) within the Neonatal Research Network (NRN). Participants include all newborn infants born at 34 0/7 weeks gestation or greater who are admitted to NICU Network centers and intubated and mechanically ventilated at less than 72 hours of age. The information gathered will provide a framework for the design of a potential randomized controlled trial for the treatment of hypotension in neonates. This observational study is for a time-limited enrollment period of 4-6 months; NRN centers will continue to enroll until at least 50 patients are enrolled per center (for approximately 800-1,000 subjects total).

Study Details

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 16, 2009
Enrollment StartApr 1, 2009
Primary CompletionDec 1, 2009
TodayJul 1, 2026
Enrollment to primary: 8 monthsPosted 17.2 years ago