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Hydrocortisone for Term Hypotension

N

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

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

Trial documents
1

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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