Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone Study (BIPED)
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|ClinicalTrials.gov Identifier: NCT03567473|
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : May 3, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis||Drug: Oral dexamethasone Drug: Nebulized Epinephrine Drug: Oral placebo Drug: Nebulized normal saline Drug: MDI Epinephrine Drug: MDI placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||864 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||All study personnel (including study nurses, coordinators, investigators, data management staff, and statistical team), health care staff providing patient care, and patients/families will be blinded to the study group assignment.|
|Official Title:||A Randomized Controlled Trial Comparing Epinephrine and Dexamethasone to Placebo in the Treatment of Infants With Bronchiolitis|
|Actual Study Start Date :||December 13, 2018|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2023|
Experimental: Active Intervention Arm
Oral dexamethasone and nebulized epinephrine OR Oral dexamethasone and inhaled epinephrine given by MDI
Drug: Oral dexamethasone
Two doses of oral dexamethasone, 0.6 mg/kg (maximum single dose 10 mg). One at the time of emergency department enrolment immediately prior to first nebulized treatment and one at approximately 24 hour later
Other Name: Dexamethasone
Drug: Nebulized Epinephrine
Two nebulized treatments of 3 mL 1:1000 epinephrine 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment
Other Name: Nebulized Adrenaline
Drug: MDI Epinephrine
Two doses of Epinephrine given by MDI plus spacer at 625 mcg (5 actuations of 125mcg) 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment.
Other Name: MDI Adrenaline
Placebo Comparator: Control Arm
Oral placebo (OraBlendTM in Canada and a compounded oral placebo solution at New Zealand/Australia sites) and nebulized saline.
OR Oral placebo (OraBlendTM in Canada and a compounded oral placebo solution at New Zealand/Australia sites) and inhaled placebo given by MDI.
Drug: Oral placebo
Two doses of oral placebo, 0.6 mL/kg (maximum single dose 10 mL). One at the time of emergency department enrolment immediately prior to nebulized treatment and one at approximately 24 hour later . Oral placebo at Canadian sites is composed of OraBlendTM and in New Zealand and Australian sites will be a compounded solution.
Other Name: Placebo
Drug: Nebulized normal saline
Two nebulized treatments of 3 mL of normal saline 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment
Other Name: Saline
Drug: MDI placebo
Two doses of inhaled placebo given by MDI plus spacer, 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment.
Other Name: Placebo
- Admission to hospital for bronchiolitis within 7 days post enrollment [ Time Frame: 7 days post enrollment ]1) patient being admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater.
- Admission to hospital for bronchiolitis at the time of the enrollment ED visit [ Time Frame: Enrollment visit ]1) patient being admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater.
- All cause admission to Hospital within 21 days following enrollment ED visit [ Time Frame: up to 21 days post enrollment ]1) patient being admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater.
- All cause Health care provider visits (including ED visits) by day 21 following enrollment ED [ Time Frame: up to 21 days post enrollment ]Visits to ED, other clinic, primary care provider, or any visit to see a nurse or physician following enrollment
- Health Care related costs within the 21 days following enrollment ED visits. [ Time Frame: up to 21 days post enrollment ]Health care related costs
- Safety outcome 1: Gastrointestinal bleeding [ Time Frame: up to 21 days post enrollment ]involving melena or frank blood per rectum (and not attributable to other causes, as determined by the treating physician)
- Safety outcome 2: Serious Bacterial Infection [ Time Frame: up to 21 days post enrollment ]meningitis, osteomyelitis or septicaemia
- Safety outcome 3: Severe Varicella [ Time Frame: up to 21 days post enrollment ]All of the following including: arthritis, osteomyelitis, symptomatic hepatitis, pancreatitis, cerebritis, pneumonitis, glomerulonephritis, disseminated intravascular coagulation, thrombo-cytopenia, prolonged vesicular rash (<3 weeks), fasciitis, septicaemia, ocular complications, orchitis, myocarditis, intensive care admission and death
- Safety outcome 4: Death [ Time Frame: up to 21 days post enrollment ]Death
- Exploratory Outcome 1: Admission to hospital for bronchiolitis within 21 days following enrollment ED visit [ Time Frame: up to 21 days post enrollment ]1) Patient admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater.
- Exploratory Outcome 2: Admission to ICU within 21 days following enrollment ED visit for bronchiolitis and requiring intubation or continuous positive airway pressure (CPAP) [ Time Frame: up to 21 days post enrollment ]Physician admitting patient to ICU for bronchiolitis and requiring oxygen or ventilatory support
- Exploratory Outcome 3: All cause admission to hospital with 7 days following enrollment ED visit [ Time Frame: up to 7 days post enrollment ED visit ]1) Patient admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater.
- Exploratory Outcome 4: All cause ED visits within 21 days following enrollment ED visit [ Time Frame: up to 21 days post enrollment ED ]Visits to the ED after initial enrollment ED visit
- Exploratory Outcome 5: Length of stay for the enrollment ED visit (in hours) [ Time Frame: Enrollment ED visit ]defined as discharge time minus oral study medication time, for participants discharged at the enrollment ED
- Exploratory Outcome 6: Length of hospital admission for those patients admitted at their enrollment visit [ Time Frame: Admissions at enrollment ED visit ]time of hospital discharge minus the time of oral study medication
- Exploratory Outcome 7: Resolution of symptoms as documented on a standardized questionnaire during the telephone or email at day 7 and 21 days. [ Time Frame: up to 21 days post enrollment ]cough, noisy breathing, respiratory distress, sleep and ability to feed
- Exploratory Outcome 8: Out of pocket expenses [ Time Frame: up to 21 days post enrollment ]transportation, days of missed work, missed leisure activities
- Exploratory Outcome 9: Age dependent variation in the efficacy of epinephrine and dexamethasone [ Time Frame: up to 21 days post enrollment ]to determine if treatment efficacy varies by age
- Exploratory Outcome 10: Health care utilization (including ambulatory visits, ED visits, hospitalization) for respiratory illness [ Time Frame: Up to 18 years of age ]future health care utilization
- Exploratory Outcome 11: Development of respiratory illnesses [ Time Frame: Up to 18 years of age ]asthma, wheezing and other respiratory illnesses
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:||60 Days to 12 Months (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Presenting to the ED with an episode of bronchiolitis. Bronchiolitis will be defined as an episode of wheezing or crackles in a child < 12 month of age associated with signs of an upper respiratory tract infection (e.g. cough, coryza, nasal congestion) during the period deemed to be peak season for RSV bronchiolitis (approximately December to April in Northern Hemisphere and June to October in Southern Hemisphere). We have chosen not to define bronchiolitis as the first episode of wheezing or crackles to better reflect the clinical guidelines and clinical practice internationally.
- Age 60 days to less than 12 months. Children younger than 60 days will not be enrolled due to the risk of concomitant infection and other issues pertaining to glucocorticoid use in the very young. Children older than 12 months will not be enrolled to minimize the risk of enrolling children with asthma.
- Respiratory distress assessment instrument (RDAI) score of less than or equal to 3. This RDAI will ensure children with very mild respiratory diseases are not enrolled. This is the lower limit of the RDAI range used in CanBEST.
- Previously known chronic disease that may affect cardiopulmonary status of the patient, such as bronchopulmonary dysplasia currently receiving oxygen, cystic fibrosis, congenital heart disease and immune deficiency. These children may be at higher risk for developing severe illness.
- Severe respiratory distress evidenced by a sustained pulse rate > 200 beats/min, a sustained respiratory rate > 80 breaths/min, profound lethargy (as deemed by the treating physician), or requiring resuscitation room care. We will exclude these children as they are likely to be admitted due to severity of illness.
- Presenting with symptoms of apnea prior to enrollment.
- Treatment with oral, inhaled, or IV corticosteroids within the last 1 week.
- History of adverse reaction to glucocorticoids.
- Treatment with any beta-agonists (salbutamol/albuterol or epinephrine/adrenaline) in the ED prior to study enrolment.
- Presence of varicella or recent (less than 3 weeks) close contact (defined as any household or daycare contact, or greater than 15 minutes of face to face contact, or greater than 1 hour of being in the same dwelling with an individual) without a history of prior infection. These patients are not enrolled to reduce any risk of developing severe varicella with corticosteroid use.
- Insurmountable language barrier (patient's parent/guardian is unable to understand English or French to give informed consent and participate in follow-up).
- Any child born at less than 37weeks gestation who is younger than 60 days corrected age. We will not enroll these children to lower any risk of exposing young infants to corticosteroids.
- Previous enrolment in the trial.
- Unavailability for follow-up period.
- Certain admission to hospital.
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): NCT03567473
|Contact: Kristina I Vogel||613-737-7600 ext email@example.com|
|Contact: Candice McGahern||613-737-7600 ext 4111||CMcGahern@cheo.on.ca|
|Women and Children's Hospital||Recruiting|
|Adelaide, Australia, 5006|
|Contact: Gaby Nivea firstname.lastname@example.org|
|Principal Investigator: Amit Kochar, MD|
|Monash Medical Centre||Recruiting|
|Melbourne, Australia, 3168|
|Contact: Jennifer Grant email@example.com|
|Principal Investigator: Simon Craig, MD|
|Perth Children's Hospital||Recruiting|
|Perth, Australia, 6008|
|Contact: Sharon O'brien Sharon.O'Brien@health.wa.gov.au|
|Principal Investigator: Meredith Borland, MD|
|Children's Hospital of Alberta||Recruiting|
|Calgary, Alberta, Canada, T3B 6A9|
|Contact: Kelly Kim 403-955-5451 firstname.lastname@example.org|
|Principal Investigator: Graham Thompson, MD|
|Stollery Children's Hospital||Recruiting|
|Edmonton, Alberta, Canada, T6G 2C8|
|Contact: Nadia Schular 587-588-7231 email@example.com|
|Principal Investigator: Andrew Dixon, MD|
|Childrens Hospital at London Health Sciences||Recruiting|
|London, Ontario, Canada, N6A 5W9|
|Contact: Leslie Boisvert Leslie.Boisvert@lhsc.on.ca|
|Principal Investigator: Gary Joubert, MD|
|Ottawa, Ontario, Canada, K1H 8L1|
|Contact: Kristina Vogel 613-737-7600 ext 3348 firstname.lastname@example.org|
|Contact: Candice McGahern 613-737-7600 ext 4111 CMcGahern@cheo.on.ca|
|Principal Investigator: Amy Plint, MD MSc|
|CHU Sainte-Justines Hospital||Recruiting|
|Montréal, Quebec, Canada, HT3 1C5|
|Contact: Stephanie Pellerin 514-345-4931 ext 3827 email@example.com|
|Principal Investigator: Serge Gouin, MD|
|Children's Hospital of Winnipeg||Recruiting|
|Sherbrook, Winnipeg, Canada, R3A 1S1|
|Contact: Lise Bourrier firstname.lastname@example.org|
|Principal Investigator: Scott Sawyer, MD|
|Starship Children's Hospital||Recruiting|
|Auckland, New Zealand, 1142|
|Contact: Megan Bonisch MBonisch@adhb.govt.nz|
|Principal Investigator: Stuart Dalziel, MD|
|Kidz First Hospital||Not yet recruiting|
|Auckland, New Zealand, 2025|
|Contact: Chris Lash email@example.com|
|Principal Investigator: Christopher Lash, MD|
|Hamilton, New Zealand, 3240|
|Contact: Julia Laing firstname.lastname@example.org|
|Principal Investigator: Alex Wallace, MD|
|Principal Investigator:||Amy Plint, MSc, MD||Childrens Hospital of Eastern Ontario (CHEO)|
|Responsible Party:||Amy Plint, MD, MSc, FRCPC, Research Chair in Pediatric Emergency Medicine, Children's Hospital of Eastern Ontario|
|Other Study ID Numbers:||
|First Posted:||June 25, 2018 Key Record Dates|
|Last Update Posted:||May 3, 2022|
|Last Verified:||April 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases, Obstructive
Peripheral Nervous System Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action