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Completed

NCT Number: NCT01954056

Hydrocortisone for Term Hypotension

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.

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Key information

Age range

34 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocortisone

Drug
  • 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Placebo

Drug

7 days of intravenous or intramuscular placebo (normal saline in equal volume)

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose

Primary outcomes

  1. Death

    Time frame: Birth to 22-26 months corrected gestational age

    This is measured as Yes if an infant died between birth and 22-26 months corrected gestational age; Otherwise, No.

  2. Number of Participants With Neurodevelopmental Impairment

    Time frame: Birth to 22-26 months corrected gestational age

    This is measured as Yes if an any hearing impairment or visual impairment is noted, if non-normal gross motor function level is noted, any seizures have been noted, or if the cognitive, language, or motor scores of the Bayley III score are more than 1 standard deviation below the average; Otherwise, No.

  3. Number of Participants With Death or Neurodevelopmental Impairment

    Time frame: Birth to 22-26 months corrected gestational age

    A composite outcome that measures the occurrence of death or neurodevelomental impairment between birth and 22-26 months corrected gestational age.

Secondary outcomes

  1. Duration of Mechanical Ventilation

    Time frame: Birth to 60 days of life

    This is measured as the number of days between birth and 60 days of life of mechanical ventialtion of laryngeal intubation.

  2. Days to Full Feeds

    Time frame: Birth to 60 days of life

    The day of life at which full nipple feeds were reached between birth and 60 days of life. Full nipple feeds are defined as at least 120 mg/kg/day.

  3. Number of Participants With Need for Gastronomy Tube

    Time frame: Birth to 60 days of life

    This is measured as Yes if a gastronomy tube was placed anytime prior to final status between birth and 60 days of life; Otherwise, No

  4. Duration of Oxygen Requirement

    Time frame: Birth to 60 days of life

    This is measured as the number of days between birth and 60 days of life that an infant was on oxygen in the hospital.

  5. Number of Participants With Need for Home Oxygen

    Time frame: Birth to 60 days of life

    This is measured as Yes if an infant was discharged to home while on oxygen between birth and 60 days of life; Otherwise, No.

  6. Hospital Length of Stay

    Time frame: Birth to 60 days of life

    This is measured as the number of days between birth and 60 days of life that an infant was in the hospital. Infants who died or transferred to another care facility were not included.

  7. Number of Participants With Renal Insufficiency

    Time frame: Birth to 60 days of life

    This is measured as Yes if an infant had renal insufficieny between birth and 60 days of life; Otherwise, No. Renal insufficiency is defined as creatinine less than 2 during 7 days after first treatment

  8. Number of Participants With Necrotizing Enterocolitis

    Time frame: Birth to 60 days of life

    This is measured as Yes if an infant necrotizing enterocolitis (NEC) between birth and 60 days of life; Otherwise, No. NEC could be proven with or without surgery

  9. Number of Participants With Need for ECMO Therapy

    Time frame: Birth to 60 days of life

    This is measured as Yes if an infant received ECMO treatment anytime between birth and 60 days of life; Otherwise, No. Extracorporeal membrane oxygenation (ECMO) is a treatment that uses a pump to circulate blood through an artificial lung back into the bloodstream of a very ill baby.

  10. Number of Participants With Inotrope Exposure

    Time frame: 24 hours prior to study drug administration through 3 days post study drug administration.

    This is measured as Yes if an infant was receiving inotropes on the specific day after the initiation of study drug.

  11. Inotrope Duration

    Time frame: 24 hours prior to study drug administration through 3 days post study drug administration.

    This is calculated as the number of days on inotropes starting 24 hours prior to initiation of study drug, during the 7-day study drug administration period, and for 3 days after the study drug.

  12. Maximum Inotrope Dose

    Time frame: From start of study drug administration (7 days) through 3 days post study drug administration.

    This is calculated as the maximum dose of all inotropes in the 10 days following the initiation of study drug administration. For the purposes of this calculation, dopamine and dobutamine doses were considered equivalent and 0.01 mcg/kg/min of epinephrine was equal to 5 mcg/kg/min of dopamine.

  13. Oxygenation Index

    Time frame: Birth to 60 days of life

    This is calculated as fraction of inspired oxygen (FiO2), as a percentage, multiplied by the mean airway pressure divided by partial pressure of oxygen in arterial blood (PaO2), during study drug administration. A lower oxygenation index is better.

  14. Respiratory Severity

    Time frame: Birth to 60 days of life

    This is calculated as fraction of inspired oxygen (FiO2), as a percentage, multiplied by the mean airway pressure during study drug administration. Higher score means more severe.

  15. Number of Participants With Fluid Boluses Given

    Time frame: Birth to 60 days of life

    This is measured as Yes if an infant received fluid boluses anytime before or during study drug administration between birth and 60 days of life; Otherwise, No.

  16. Number of Boluses Given

    Time frame: Birth to 60 days of life

    The number of fluid boluses given per participant, if any, before or during study drug administration between birth and 60 days of life

Sponsors and collaborators

Lead sponsor

NICHD Neonatal Research Network

Network

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Center for Research Resources (NCRR)

Registry information

Official study title

Hydrocortisone Treatment of Cardiovascular Insufficiency in Term and Late Preterm Infants: A Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 1, 2013
Registry last updated
Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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