Hydrocortisone for Term Hypotension

• Status: Completed
• Trial end date: 2018-03-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NICHD Neonatal Research Network
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Center for Research Resources (NCRR)
• Treatments: Benzyl Alcohol; Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

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