Hydrocortisone for Term Hypotension

Status Completed

Clinical Trial Summary

This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.

Clinical Trial Description

Cardiovascular insufficiency is common and potentially life-threatening in critically ill term and late preterm newborns admitted to the newborn intensive care unit (NICU) in the first few days of age. This study proposes to conduct a multicenter, randomized, masked, placebo-controlled trial within the Neonatal Research Network (NRN). This trial will evaluate the effects of a 7-day course of hydrocortisone therapy on short-term morbidity, cardiovascular function, long-term neurodevelopment, and mortality in critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01954056
Study type	Interventional
Source	NICHD Neonatal Research Network
Contact
Status	Completed
Phase	Phase 3
Start date	June 19, 2014
Completion date	March 20, 2018

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