Hydrocortisone for BPD



Status:Active, not recruiting
Conditions:Bronchitis, Women's Studies
Therapuetic Areas:Pulmonary / Respiratory Diseases, Reproductive
Healthy:No
Age Range:Any
Updated:3/13/2019
Start Date:September 2011
End Date:January 2025

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A Randomized Controlled Trial of the Effect Of Hydrocortisone on Survival Without Bronchopulmonary Dysplasia and on Neurodevelopmental Outcomes at 22 - 26 Months of Age in Intubated Infants < 30 Weeks Gestation Age

The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course
of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who
are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or
placebo. This study will determine if hydrocortisone improves infants'survival without
moderate or severe BPD and will be associated with improvement in survival without moderate
or severe neurodevelopmental impairment at 22 - 26 months corrected age.

Bronchopulmonary dysplasia (BPD) remains a leading morbidity of the extremely preterm infant,
and prolonged mechanical ventilation is associated with increased risk for BPD. Dexamethasone
has been used previously to facilitate extubation and decrease the incidence of BPD; however,
due to adverse effects on neurodevelopmental outcomes, the use of this drug has decreased.
One cohort study suggests that hydrocortisone (HC) may facilitate extubation. HC has thus far
not been associated with adverse neurodevelopmental outcomes in either cohort studies or
randomized controlled trials. A recent meta-analysis of postnatal corticosteroid therapy
begun after the first week of life suggested that "late therapy may reduce neonatal mortality
without significantly increasing the risk of adverse long-term neurodevelopmental outcomes,"
although the methodological quality of some of the follow-up was acknowledged to be limited.

This is a randomized controlled trial to study the efficacy and safety of a 10-day tapering
course of hydrocortisone treatment for infants <30 weeks estimated gestational age at birth
who remain intubated at 14 - 28 days postnatal age. Based on previous Network data these
criteria define a population with a risk of death or BPD at 36 weeks postmenstrual age of
approximately 65 - 75%. The primary outcome for this study will incorporate both (1) survival
without moderate to severe BPD by Network physiologic definition and (2) survival without
moderate or severe NDI at 18 - 22 months corrected age. Therefore, the results of this study
will be reported only when follow-up data are available unless (1) the trial is stopped early
by the DSMC because of strong evidence of benefit or harm, or (2) at the time all subjects
have completed treatment the DCC finds a substantial survival benefit favoring hydrocortisone
(p<0.001). Individual study assignment will remain masked until the follow-up is completed.
Secondary outcomes will include short term measures such as respiratory morbidities and
growth at 36 weeks postmenstrual age and long term measures including growth and other
outcomes at 22 - 26 months corrected age.

Secondary studies include:

1)Effect of Hydrocortisone on the Cardiac mass of Premature Intubated Infants - will
determine left ventricular mass index at 36 weeks postmenstrual age (or prior to
discharge/transfer if after 34 weeks) in infants enrolled in the hydrocortisone for BPD RCT,
and compare HC-treated infants to placebo-treated infants. It will similarly assess and
compare the incidence of pulmonary hypertension in these patients.

Extended follow-up: Subjects will be seen for a follow-up visit at 5-6 years corrected age to
assess functional developmental and respiratory outcomes at early school age. In a subset of
four Neonatal Research Network Clinical Centers, impulse oscillometry (IOS), which is the
optimal direct measure of lung capacity and function, will be performed to validate the
6-minute walk test and International Study of Asthma and Allergies in Childhood (ISAAC)
questionnaire as functional measures of pulmonary status.

Inclusion Criteria:

- infants <30 weeks estimated gestational age

- inborn at an NRN site or were admitted to an NRN site before 72 hours postnatal age

- have received at least 7days of mechanical ventilation;

- are receiving mechanical ventilation through an endotracheal tube .

Exclusion Criteria:

- Major congenital anomalies

- Decision to limit support

- Indomethacin or ibuprofen treatment within 48 hours of study drug

- Previous corticosteroid treatment for BPD

- Received hydrocortisone for 14 or more cumulative days

- Received hydrocortisone within 7 days of study entry
We found this trial at
20
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Waldemar A. Carlo, MD
Phone: 205-934-4680
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: David P Carlton, MD
Phone: 404-727-2456
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Myra Wyckoff, MD
Phone: 214-648-3923
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Dallas, TX
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Principal Investigator: Seetha Shankaran, MD
Phone: 313-745-1436
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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3040 East Cornwallis RoadTriangle
Durham, North Carolina 27705
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Durham, NC
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Durham, North Carolina 27710
(919) 684-8111
Phone: 919-681-6024
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Jon E. Tyson, MD MPH
Phone: 713-500-6708
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Brenda B. Poindexter, MD MS
Phone: 317-274-4768
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Edward F. Bell, MD
Phone: 319-356-4006
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: William Truog, MD
Phone: 816-234-3592
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Uday Devaskar, MD
Phone: 310-825-9314
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Providence, Rhode Island 02905
Principal Investigator: Abbot R. Laptook, MD
Phone: 401-274-1122
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Carl T D'Angio, MD
Phone: 585-273-4911
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Bradley A. Yoder, MD
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Kristi L. Watterberg, MD
Phone: 505-272-8609
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Cincinnati, Ohio 45267
Principal Investigator: Brenda Poindexter, MD
Phone: 513-636-3972
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Cleveland, Ohio 44106
Principal Investigator: Michele C. Walsh, MD MS
Phone: 216-844-3387
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Columbus, Ohio 43205
Principal Investigator: Pablo Sanchez, MD
Phone: 614-355-6724
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Palo Alto, California 94304
Principal Investigator: Krisa P. Van Meurs, MD
Phone: 650-723-5711
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Philadelphia, Pennsylvania 19104
Principal Investigator: Eric Eicenwald, MD
Phone: 215-662-3228
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