Hydrocortisone for Term Hypotension

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-19

Study Completion Date

2018-03-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Infant, Newborn, Diseases Cardiovascular Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hydrocortisone

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

Group Type ACTIVE_COMPARATOR

Hydrocortisone

Intervention Type 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

Saline placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

Interventions

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Hydrocortisone

• 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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

34 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michele C Walsh, MD

Role: PRINCIPAL_INVESTIGATOR

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

Seetha Shankaran, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Abbot R Laptook, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University, Women & Infants Hospital of Rhode Island

Ron N Goldberg, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Barbara J Stoll, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Brenda B Poindexter, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Abhik Das, PhD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Krisa P Van Meurs, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Kurt Schibler, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Waldemar Carlo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Edward F Bell, MD

Role: PRINCIPAL_INVESTIGATOR

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

Erika Fernandez, MD

Role: STUDY_CHAIR

University of New Mexico

Myra Wycoff, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas, Southwestern Medical Center at Dallas

Kathleen A Kennedy, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Barbara Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Carl T D'Angio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Uday Devaskar, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Leif Nelin, MD

Role: PRINCIPAL_INVESTIGATOR

Research Institute at Nationwide Children's Hospital

William Truog, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of California - Los Angeles

Los Angeles, California, United States

Site Status

Stanford University

Palo Alto, California, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

RTI International

Durham, North Carolina, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document