Hydrocortisone for BPD
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infant, Newborn Infant, Small for Gestational Age Infant, Very Low Birth Weight Infant, Premature Bronchopulmonary Dysplasia |
Drug: Hydrocortisone Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | 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 |
- Efficacy [ Time Frame: Birth to 26 months corrected age ] [ Designated as safety issue: Yes ]Improvement in survival without physiologically defined moderate to severe BPD.
- Safety [ Time Frame: Birth to 26 months corrected age ] [ Designated as safety issue: Yes ]Survival without moderate or severe neurodevelopmental impairment at 18 - 22 months corrected age
- Morbidity and Growth [ Time Frame: Birth to 26 months corrected age ] [ Designated as safety issue: Yes ]
- Successful Extubation [ Time Frame: 36 Weeks Post Menstrual Age ] [ Designated as safety issue: Yes ]
- Use of open-label dexamethasone [ Time Frame: 36 Weeks Post Menstrual Age ] [ Designated as safety issue: Yes ]
- Respiratory status at 40 weeks [ Time Frame: 40 weeks Postmenstrual Age ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 800 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Saline placebo
|
Drug: Placebo
Saline placebo to be administered either intravenously or orally if no intravenous line is available, at the same dose, and tapered as follows: 4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then 1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days |
|
Experimental: Hydrocortisone
hydrocortisone sodium succinate for intravenous administration (unpreserved, Solu-Cortef plain, Pfizer®, reconstituted with unpreserved normal saline to avoid exposure to the benzyl alcohol contained in preserved diluents)
|
Drug: Hydrocortisone
Hydrocortisone sodium succinate for intravenous administration (unpreserved, Solu-Cortef plain, Pfizer®, reconstituted with unpreserved normal saline to avoid exposure to the benzyl alcohol contained in preserved diluents), to be administered either intravenously or orally if no intravenous line is available at the same dose, and tapered as follows: 4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then 1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | up to 30 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Kristi L Watterberg, MD | 505-272-3967 | kwatterberg@salud.unm.edu |
| Contact: Rosemary D Higgins, MD | (301) 496-5575 | higginsr@mail.nih.gov |
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Waldemar A. Carlo, MD 205-934-4680 wcarlo@peds.uab.edu | |
| Contact: Monica V. Collins, RN BSN (205) 934-5771 mcollins@peds.uab.edu | |
| Principal Investigator: Waldemar A. Carlo, MD | |
| United States, California | |
| University of California - Los Angeles | Recruiting |
| Los Angeles, California, United States, 90025 | |
| Contact: Uday Devaskar, MD 310-825-9357 udevaskar@mednet.ucla.edu | |
| Contact: Teresa Chanlaw, BS (310) 794-4972 tchanlaw@mednet.ucla.edu | |
| Principal Investigator: Uday Devaskar, MD | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Krisa P. Van Meurs, MD 650-723-5711 vanmeurs@leland.stanford.edu | |
| Contact: M. Bethany Ball, BS CCRC (650) 725-8342 mbball@stanford.edu | |
| Principal Investigator: Krisa P. Van Meurs, MD | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: Barbara J. Stoll, MD 404-727-5740 barbara_stoll@oz.ped.emory.edu | |
| Contact: Ellen Hale, RN BS (404) 616-4218 ellen_hale@oz.ped.emory.edu | |
| Principal Investigator: Barbara J. Stoll, MD | |
| United States, Indiana | |
| Indiana University | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Brenda B. Poindexter, MD MS 317-274-3592 bpoindex@iupui.edu | |
| Contact: Leslie D. Wilson, RN BSN (317) 274-8255 ldw@iupui.edu | |
| Principal Investigator: Brenda B. Poindexter, MD MS | |
| United States, Iowa | |
| University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Edward F. Bell, MD 319-356-4006 edward-bell@uiowa.edu | |
| Contact: Karen J. Johnson, RN BSN (319) 356-2924 karen-johnson@uiowa.edu | |
| Principal Investigator: Edward F. Bell, MD | |
| United States, Michigan | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Seetha Shankaran, MD 313-580-4452 sshankar@med.wayne.edu | |
| Contact: Rebecca Bara, RN BSN (313) 745-1436 rbara@med.wayne.edu | |
| Principal Investigator: Seetha Shankaran, MD | |
| United States, Missouri | |
| Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: William Truog, MD 816-234-3592 wtruog@cmh.edu | |
| Contact: Cheri Gauldin, BSN (816) 234-3920 cagauldin@cmh.edu | |
| Principal Investigator: William Truog, MD | |
| United States, New Mexico | |
| University of New Mexico | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Kristi L. Watterberg, MD 505-272-3967 kwatterberg@salud.unm.edu | |
| Contact: Conra Backstrom Lacy, RN (505) 272-0367 cbackstrom@salud.unm.edu | |
| Principal Investigator: Kristi L. Watterberg, MD | |
| United States, New York | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Carl T D'Angio, MD 585-273-4911 carl_dangio@urmc.rochester.edu | |
| Principal Investigator: Carl T D'Angio, MD | |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Ronald N. Goldberg, MD 919-681-6025 goldb008@mc.duke.edu | |
| Contact: Gloria Siaw, BSN CRA (919) 681-5859 gloria.siaw@duke.edu | |
| Principal Investigator: Ronald N. Goldberg, MD | |
| Sub-Investigator: C. Michael Cotten, MD MHS | |
| RTI International | Active, not recruiting |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Cincinnati Children's Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Kurt Schibler, MD 513-636-3972 kurt.schibler@cchmc.org | |
| Contact: Cathy Grisby, BSN CCRC (513) 558-4953 grisbyca@email.uc.edu | |
| Principal Investigator: Kurt Schibler, MD | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Michele C. Walsh, MD MS 216-844-3759 mcw3@cwru.edu | |
| Contact: Nancy S. Newman, BA RN (216) 368-3084 nxs5@cwru.edu | |
| Principal Investigator: Michele C. Walsh, MD MS | |
| Research Institute at Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Leif Nelin, MD 614-722-3030 Leif.Nelin@nationwidechildrens.org | |
| Contact: Christine Fortney, MS, RN 614-722-6489 christine.fortney@nationwidechildrens.org | |
| Principal Investigator: Leif Nelin, MD | |
| United States, Pennsylvania | |
| Univeristy of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Barbara Schmidt, MD 215-662-3228 barbara.schmidt@uphs.upenn.edu | |
| Contact: Aasma Chaudhary, BS 215-615-5442 aasma.chaudhary@uphs.upenn.edu | |
| Principal Investigator: Barbara Schmidt, MD | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | Recruiting |
| Providence, Rhode Island, United States, 02905 | |
| Contact: Abbot R. Laptook, MD 401-274-1122 alaptook@WIHRI.org | |
| Contact: Angelita Hensman (401) 274-1122 ahensman@wihri.org | |
| Principal Investigator: Abbot R. Laptook, MD | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Pablo J. Sanchez, MD 214-648-3753 Pablo.Sanchez@UTSouthwestern.edu | |
| Contact: Diana M. Vasil, RNC-NIC (214) 648-3789 Diana.Vasil@utsouthwestern.edu | |
| Principal Investigator: Pablo J. Sanchez, MD | |
| University of Texas Health Science Center at Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Kathleen A. Kennedy, MD MPH 713-500-6708 Kathleen.A.Kennedy@uth.tmc.edu | |
| Contact: Georgia E. McDavid, RN (713) 500-5734 Georgia.E.McDavid@uth.tmc.edu | |
| Principal Investigator: Kathleen A. Kennedy, MD MPH | |
| Sub-Investigator: Jon E. Tyson, MD MPH | |
| Principal Investigator: | 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 | Cincinnati Children's Medical Center |
| Principal Investigator: | Waldemar A Carlo, MD | University of Alabama at Birmingham |
| Principal Investigator: | Edward F Bell, MD | University of Iowa |
| Study Chair: | Kristi L Watterberg, MD | University of New Mexico |
| Principal Investigator: | Pablo J Sanchez, 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, MO |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT01353313 History of Changes |
| Other Study ID Numbers: | NICHD-NRN-0045, U10HD034216, U10HD027904, U10HD021364, U10HD027853, U10HD040689, U10HD040492, U10HD027851, U10HD021373, U10HD027856, U10HD053109, U10HD036790, U10HD027880, U10HD053089, U10HD021385, U10HD068244, U10HD068263, U10HD068270, U10HD068278, U10HD068284 |
| Study First Received: | April 20, 2011 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Very Low Birth Weight (VLBW) Prematurity |
Mechanical ventilation Intubation Neurodevelopmental impairment |
Additional relevant MeSH terms:
|
Infant, Premature, Diseases Infant, Newborn, Diseases Birth Weight Bronchopulmonary Dysplasia Body Weight Signs and Symptoms Ventilator-Induced Lung Injury Lung Injury Lung Diseases Respiratory Tract Diseases |
Cortisol succinate Hydrocortisone acetate Hydrocortisone 17-butyrate 21-propionate Hydrocortisone Hydrocortisone-17-butyrate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Dermatologic Agents |
ClinicalTrials.gov processed this record on May 21, 2013