Hydrocortisone for Term Hypotension

NICHD Neonatal Research Network

Status and phase: Completed; Phase 3

Conditions: Cardiovascular Insufficiency; Infant, Newborn, Diseases

Treatments: Drug: Hydrocortisone; Drug: Placebo

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT01954056

U10HD053109 (U.S. NIH Grant/Contract)

U10HD021373 (U.S. NIH Grant/Contract)

U10HD027853 (U.S. NIH Grant/Contract)

U10HD068270 (U.S. NIH Grant/Contract)

U10HD021364 (U.S. NIH Grant/Contract)

U10HD027880 (U.S. NIH Grant/Contract)

U10HD036790 (U.S. NIH Grant/Contract)

U10HD027856 (U.S. NIH Grant/Contract)

U10HD040492 (U.S. NIH Grant/Contract)

U10HD027851 (U.S. NIH Grant/Contract)

U10HD068244 (U.S. NIH Grant/Contract)

U10HD040689 (U.S. NIH Grant/Contract)

U10HD068284 (U.S. NIH Grant/Contract)

NICHD-NRN-0052

U10HD068263 (U.S. NIH Grant/Contract)

U10HD034216 (U.S. NIH Grant/Contract)

U10HD021385 (U.S. NIH Grant/Contract)

U10HD027904 (U.S. NIH Grant/Contract)

U10HD068278 (U.S. NIH Grant/Contract)

U10HD040461 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 34+ weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Hydrocortisone

Active Comparator group

Description:

hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line

Treatment:

Drug: Hydrocortisone

Placebo

Placebo Comparator group

Description:

Saline placebo

Treatment:

Drug: Placebo