Hydrocortisone for BPD
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| ClinicalTrials.gov Identifier: NCT01353313 |
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Recruitment Status :
Recruiting
First Posted : May 13, 2011
Last Update Posted : December 15, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infant, Newborn Infant, Small for Gestational Age Infant, Very Low Birth Weight Infant, Premature Bronchopulmonary Dysplasia | Drug: Hydrocortisone Drug: Placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 800 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, 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 |
| Study Start Date : | September 2011 |
| Estimated Primary Completion Date : | January 2020 |
| Estimated Study Completion Date : | January 2025 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Saline placebo
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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 |
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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)
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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 |
- Efficacy [ Time Frame: Birth to 26 months corrected age ]Improvement in survival without physiologically defined moderate to severe BPD.
- Safety [ Time Frame: Birth to 26 months corrected age ]Survival without moderate or severe neurodevelopmental impairment at 18 - 22 months corrected age
- Morbidity and Growth [ Time Frame: Birth to 26 months corrected age ]
- Successful Extubation [ Time Frame: 36 Weeks Post Menstrual Age ]
- Use of open-label dexamethasone [ Time Frame: 36 Weeks Post Menstrual Age ]
- Respiratory status at 40 weeks [ Time Frame: 40 weeks Postmenstrual Age ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 30 Weeks (Child) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353313
| Contact: Kristi L Watterberg, MD | 505-272-8609 | ||
| Contact: Rosemary D Higgins, MD | (301) 496-5575 |
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Waldemar A. Carlo, MD | |
| Principal Investigator: Waldemar A. Carlo, MD | |
| United States, California | |
| University of California - Los Angeles | Active, not recruiting |
| Los Angeles, California, United States, 90025 | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Krisa P. Van Meurs, MD | |
| Principal Investigator: Krisa P. Van Meurs, MD | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: David P Carlton, MD | |
| Principal Investigator: David P Carlton, MD | |
| United States, Indiana | |
| Indiana University | Active, not recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Edward F. Bell, MD | |
| Principal Investigator: Edward F. Bell, MD | |
| United States, Michigan | |
| Wayne State University | Active, not recruiting |
| Detroit, Michigan, United States, 48201 | |
| United States, Missouri | |
| Children's Mercy Hospital | Active, not recruiting |
| Kansas City, Missouri, United States, 64108 | |
| United States, New Mexico | |
| University of New Mexico | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Kristi L. Watterberg, MD | |
| 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 | |
| Principal Investigator: Carl T D'Angio, MD | |
| United States, North Carolina | |
| RTI International | Active, not recruiting |
| Durham, North Carolina, United States, 27705 | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: C. Michael Cotten, MD | |
| Sub-Investigator: C. Michael Cotten, MD MHS | |
| United States, Ohio | |
| Cincinnati Children's Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Brenda Poindiexter, MD | |
| Principal Investigator: Brenda Poindexter, MD | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Michele C. Walsh, MD MS | |
| Principal Investigator: Michele C. Walsh, MD MS | |
| Research Institute at Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Pablo Sanchez, MD | |
| Principal Investigator: Pablo Sanchez, MD | |
| United States, Pennsylvania | |
| Univeristy of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Eric Eichenwald, MD | |
| Principal Investigator: Eric Eicenwald, 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 | |
| Principal Investigator: Abbot R. Laptook, MD | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Myra Wyckoff, MD | |
| Principal Investigator: Myra Wyckoff, MD | |
| University of Texas Health Science Center at Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jon E Tyson, MD MPH | |
| Principal Investigator: Jon E. Tyson, MD MPH | |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84108 | |
| Contact: Bradley Yoder, MD | |
| Principal Investigator: Bradley A. Yoder, MD | |
| 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: | C. Michael Cotten, MD | Duke University | |
| Principal Investigator: | David Carlton, MD | Emory University | |
| Principal Investigator: | Greg Sokol, MD | Indiana University | |
| Principal Investigator: | Abhik Das, PhD | RTI International | |
| Principal Investigator: | Krisa P Van Meurs, MD | Stanford University | |
| Principal Investigator: | Brenda P Poindexter, MD | Children's Hospital Medical Center, Cincinnati | |
| 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: | Myra Wyckoff, MD | University of Texas, Southwestern Medical Center at Dallas | |
| Principal Investigator: | Jon E Tyson, MD, MPH | The University of Texas Health Science Center, Houston | |
| Principal Investigator: | Eric Eichenwald, 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: | Pablo J Sanchez, MD | Research Institute at Nationwide Children's Hospital | |
| Principal Investigator: | William Truog, MD | Children's Mercy Hospital Kansas City | |
| Principal Investigator: | Bradley Yoder, MD | University of Utah |
Additional Information:
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by NICHD Neonatal Research Network:
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NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Very Low Birth Weight (VLBW) Prematurity |
Mechanical ventilation Intubation Neurodevelopmental impairment |
Additional relevant MeSH terms:
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Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases Birth Weight Bronchopulmonary Dysplasia Body Weight Signs and Symptoms Ventilator-Induced Lung Injury Lung Injury Hydrocortisone 17-butyrate 21-propionate |
Hydrocortisone acetate Cortisol succinate Hydrocortisone Benzyl Alcohol Anti-Inflammatory Agents Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |