Hydrocortisone for Term Hypotension

NCT01954056 | Completed Phase 3 Results DMC

• 20 other identifiers: NICHD-NRN-0052U10HD021364U10HD040689U10HD021385U10HD027851U10HD027853U10HD027856U10HD027904U10HD027880U10HD034216U10HD021373U10HD040492U10HD053109U10HD040461U10HD068244U10HD068263U10HD068270U10HD068278U10HD068284U10HD036790
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Infant, Newborn, Diseases; Cardiovascular Insufficiency

Keywords

NICHD Neonatal Research Network; Mechanical ventilation; Intubation; Neurodevelopmental impairment

Outcome Measures

Primary Outcomes (3)

• Death

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

  Birth to 22-26 months corrected gestational age

• Number of Participants With Neurodevelopmental Impairment

  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.

  Birth to 22-26 months corrected gestational age

• Number of Participants With Death or Neurodevelopmental Impairment

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

  Birth to 22-26 months corrected gestational age

Secondary Outcomes (16)

• Duration of Mechanical Ventilation

  Birth to 60 days of life

• Days to Full Feeds

  Birth to 60 days of life

• Number of Participants With Need for Gastronomy Tube

  Birth to 60 days of life

• Duration of Oxygen Requirement

  Birth to 60 days of life

• Number of Participants With Need for Home Oxygen

  Birth to 60 days of life

Study Arms (2)

Hydrocortisone

ACTIVE COMPARATOR

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

Drug: Hydrocortisone

Placebo

PLACEBO COMPARATOR

Saline placebo

Drug: Placebo

Interventions

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

Hydrocortisone

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

Placebo

Eligibility Criteria

• Age: 34 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (18)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California - Los Angeles

Los Angeles, California, 90025, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

RTI International

Durham, North Carolina, 27705, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Links

• NICHD Neonatal Research Network site
• NICHD Pregnancy \& Perinatology Branch

MeSH Terms

Conditions

Infant, Newborn, Diseases

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Limitations and Caveats

The study was closed to enrollment after 12 participants due to slow recruitment.

Results Point of Contact

• Title: Dr. Kristi Watterberg
• Organization: University of New Mexico

KWatterberg@salud.unm.edu

505-272-8609

Study Officials

• Michele C Walsh, MD

  Case Western Reserve University, Rainbow Babies and Children's Hospital

  PRINCIPAL INVESTIGATOR

• Seetha Shankaran, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Abbot R Laptook, MD

  Brown University, Women & Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

• Ron N Goldberg, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Barbara J Stoll, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Brenda B Poindexter, MD, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

• Abhik Das, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

• Krisa P Van Meurs, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Kurt Schibler, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Waldemar Carlo, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Edward F Bell, MD

  Michele C Walsh, MD Study Principal Investigator Case Western Reserve University, Rainbow Babies and Children's Hospital Seetha Shankaran, MD Study Principal Investigator Wayne State University Abbot R Laptook, MD Study Principal Investigator Brown Un

  PRINCIPAL INVESTIGATOR

• Erika Fernandez, MD

  University of New Mexico

  STUDY CHAIR

• Myra Wycoff, MD

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

• Kathleen A Kennedy, MD, MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Barbara Schmidt, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Carl T D'Angio, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Uday Devaskar, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Leif Nelin, MD

  Research Institute at Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

• William Truog, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 1, 2013
• Study Start: June 19, 2014
• Primary Completion: March 20, 2018
• Study Completion: March 20, 2018
• Last Updated: July 6, 2021
• Results First Posted: April 2, 2019

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)