Hydrocortisone for Term Hypotension

Condition(s) targeted: Infant, Newborn, Diseases; Cardiovascular Insufficiency

Intervention: Hydrocortisone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Suspended

Sponsored by: NICHD Neonatal Research Network

Official(s) and/or principal investigator(s):
Michele C Walsh, MD, Principal Investigator, Affiliation: Case Western Reserve University, Rainbow Babies and Children's Hospital
Seetha Shankaran, MD, Principal Investigator, Affiliation: Wayne State University
Abbot R Laptook, MD, Principal Investigator, Affiliation: Brown University, Women & Infants Hospital of Rhode Island
Ron N Goldbert, MD, Principal Investigator, Affiliation: Duke University
Barbara J Stoll, MD, Principal Investigator, Affiliation: Emory University
Brenda B Poindexter, MD, MS, Principal Investigator, Affiliation: Indiana University
Abhik Das, PhD, Principal Investigator, Affiliation: RTI International
Krisa P Van Meurs, MD, Principal Investigator, Affiliation: Stanford University
Kurt Schibler, MD, Principal Investigator, Affiliation: Cincinnati Children's Medical Center
Waldemar Carlo, MD, Principal Investigator, Affiliation: University of Alabama at Birmingham
Edward F Bell, MD, Principal Investigator, Affiliation: 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, Study Chair, Affiliation: University of New Mexico
Myra Wycoff, MD, Principal Investigator, Affiliation: University of Texas Southwestern Medical Center at Dallas
Kathleen A Kennedy, MD, MPH, Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston
Barbara Schmidt, MD, Principal Investigator, Affiliation: University of Pennsylvania
Carl T D'Angio, MD, Principal Investigator, Affiliation: University of Rochester
Uday Devaskar, MD, Principal Investigator, Affiliation: University of California, Los Angeles
Leif Nelin, MD, Principal Investigator, Affiliation: Research Institute at Nationwide Children's Hospital
William Truod, MD, Principal Investigator, Affiliation: Children's Mercy Hospital-Kansas City, MO

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Death or neurodevelopmental impairment

Secondary outcome:

Duration of mechanical ventilation

Days to full feeds

Need for gastrostomy tube

Duration of oxygen requirement

Need for home oxygen

Hospital length of stay

Renal insufficiency

Necrotizing enterocolitis

Need for ECMO Therapy

Death

Neurodevelopmental Impairment

Severity of illness

Inotrope exposure

Fluid bolus exposure

Detailed 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.

Minimum age: 34 Weeks. Maximum age: N/A. Gender(s): Both.

Criteria:

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

University of Alabama at Birmingham, Birmingham, Alabama 35233, United States

University of California - Los Angeles, Los Angeles, California 90025, United States

Stanford University, Palo Alto, California 94304, United States

Emory University, Atlanta, Georgia 30303, United States

Indiana University, Indianapolis, Indiana 46202, United States

University of Iowa, Iowa City, Iowa 52242, United States

Wayne State University, Detroit, Michigan 48201, United States

Children's Mercy Hospital, Kansas City, Missouri 64108, United States

University of New Mexico, Albuquerque, New Mexico 87131, United States

University of Rochester, Rochester, New York 14642, United States

Duke University, Durham, North Carolina 27710, United States

RTI International, Durham, North Carolina 27705, United States

Cincinnati Children's Medical Center, Cincinnati, Ohio 45267, United States

Case Western Reserve University, Cleveland, Ohio 44106, United States

Research Institute at Nationwide Children's Hospital, Columbus, Ohio 43205, United States

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Brown University, Women & Infants Hospital of Rhode Island, Providence, Rhode Island 02905, United States

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75235, United States

University of Texas Health Science Center at Houston, Houston, Texas 77030, United States

NICHD Neonatal Research Network site

NICHD Pregnancy & Perinatology Branch

Starting date: July 2014
Last updated: July 24, 2015