Asthma in ChildrenEarly Phase 1NCT06137040
Timely Administration of IV Magnesium Sulfate in Patients With a Moderate Asthma Exacerbation
A Early Phase 1 study testing Magnesium Sulfate within the first hour and No Magnesium sulfate within the first hour in people with Asthma in Children and Asthma Attack, run by University of Oklahoma at 1 site in United States.
Trial summary
This study aims to identify whether early administration of magnesium sulfate in moderate asthma exacerbations can potentially avoid admission, decrease length of stay in the emergency department (ED), decrease length of stay (LOS) in the general hospital floor vs pediatric intensive care unit (PICU), and decrease the… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Asthma in Children, Asthma Attack
- What is being tested?
- Magnesium Sulfate within the first hour and No Magnesium sulfate within the first hour
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2023to 31 May 2025
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 5-17 years old
- Presents to the ED with a respiratory score in the "Moderate" range (6
- Parent(s)/Caregiver(s) speak English
Who cannot join
- Patients with chronic medical conditions including chronic pulmonary disease (other than asthma), cerebral palsy, congenital heart disease, tracheostomy dependent, myasthenia gravis patients
- Patients who are pregnant
- Parent(s)/Caregiver(s) do not speak English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oklahoma Children's Hospital
Oklahoma City, Oklahoma, 73104
Ryan McKee, MD, 405-271-2429, Ryan-McKee@ouhsc.edu
About this study
This study aims to identify whether early administration of magnesium sulfate in moderate asthma exacerbations can potentially avoid admission, decrease length of stay in the emergency department (ED), decrease length of stay (LOS) in the general hospital floor vs pediatric intensive care unit (PICU), and decrease the need for respiratory support.
Read the detailed description
Patients ages 5-17 presenting to the OU Children's Hospital Emergency Department from October 2023 to July 2024 will be assigned a respiratory score (RS) upon presentation. Those with a RS between 6-9 (moderate exacerbation) will be screened for inclusion. Eligible patient will then be approached for consent. First line asthma therapies including bronchodilators and steroids will not be delayed for the consent process. Patients who consent will be randomized to the control vs. experimental group once consent is obtained.
The study will not be blinded once a patient is randomized to a group, the provider will know whether the patient will receive weight-based IV magnesium within the first hour (experimental group) or receive standard weight-based IV magnesium sulfate per the provider's clinical judgement (placebo group). Magnesium sulfate dosing for the experimental group will be as follows:
15-19 kg: 750 mg
20-29 kg: 1000 mg
30-39 kg: 1500 mg
>40 kg: 2000 mg
Enrolled patients will have their clinical course reviewed and data obtained regarding LOS in ED and hospital stay, need for respiratory support, and or PICU LOS if applicable.
- Conditions
- Asthma in Children, Asthma Attack
- Being tested
- Magnesium Sulfate within the first hour, No Magnesium sulfate within the first hour
- Keywords
- asthma exacerbation, magnesium sulfate, asthma, asthma attack
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate within the first hourDrug
Also called Magnesium within the first hour
The experimental group will receive 40-50 mg/kg of IV magnesium sulfate will be given to the experimental group alongside the first line asthma therapies (ie inhaled beta agonists, IV steroids). This will be given with a 20 mL/kg normal saline bolus (max 1000 mL) to avoid possible hypotension.
15-19 kg: 750 mg
20-29 kg: 1000 mg
30-39 kg: 1500 mg
>40 kg: 2000 mg
No Magnesium sulfate within the first hourOther
Also called No magnesium within the first hour
The control group will not receive IV magnesium sulfate within the first hour of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulfate in the first hour | Experimental | These patients will receive 40-50 mg/kg IV magnesium sulfate within the first hour of treatment alongside all first line asthma exacerbation therapies (ie inhaled beta agonists, IV steroids). Receives: Drug: Magnesium Sulfate within the first hour |
| No Magnesium Sulfate | Placebo comparator | These patients will not receive IV magnesium sulfate within the first hour of treatment but may receive it later if the provider feels it is clinically necessary. Receives: Other: No Magnesium sulfate within the first hour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Length of Stay in Patients who receive IV Magnesium within the first hour (experimental group) vs control group
Evaluating whether timely administration of IV magnesium sulfate in moderate asthma exacerbations can reduce length of stay in the ED, general hospital bed or PICU. The data will also be analyzed to determine if more patients in the experimental group were able to be discharged from the emergency department compared to the control group.
Measured: From initiation of therapy to discharge from the emergency department or admitting unit, up to 1 week
Secondary outcomes (1)
Evaluate the need for respiratory support in patients receiving magnesium sulfate within the first hour (experimental group) vs control group
Evaluating whether timely administration of IV magnesium sulfate in moderate asthma exacerbations can decrease the need for respiratory support including invasive and non-invasive respiratory support devices.
Measured: Time of initiation of therapy to discharge from the hospital, up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start30 Nov 2023
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experiment group will receive magnesium sulfate within the first hour with all of the other first line treatments vs. control group will not receive magnesium sulfate within the first hour of treatment.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan McKee, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137040
- Sponsor's protocol ID
- 16339
- Status last verified
- Dec 2024
- First submitted
- 9 Oct 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheuk DK, Chau TC, Lee SL. A meta-analysis on intravenous magnesium sulphate for treating acute asthma. Arch Dis Child. 2005 Jan;90(1):74-7. doi: 10.1136/adc.2004.050005.
PubMed 15613519Kokotajlo S, Degnan L, Meyers R, Siu A, Robinson C. Use of intravenous magnesium sulfate for the treatment of an acute asthma exacerbation in pediatric patients. J Pediatr Pharmacol Ther. 2014 Apr;19(2):91-7. doi: 10.5863/1551-6776-19.2.91.
PubMed 25024668Liu X, Yu T, Rower JE, Campbell SC, Sherwin CM, Johnson MD. Optimizing the use of intravenous magnesium sulfate for acute asthma treatment in children. Pediatr Pulmonol. 2016 Dec;51(12):1414-1421. doi: 10.1002/ppul.23482. Epub 2016 May 24.
PubMed 27218606Shein SL, Farhan O, Morris N, Mahmood N, Alter SJ, Biagini Myers JM, Gunkelman SM, Kercsmar CM, Khurana Hershey GK, Martin LJ, McCoy KS, Ruddy JR, Ross KR. Adjunctive Pharmacotherapies in Children With Asthma Exacerbations Requiring Continuous Albuterol Therapy: Findings From The Ohio Pediatric Asthma Repository. Hosp Pediatr. 2018 Jan 5;8(2):89-95. doi: 10.1542/hpeds.2017-0088. Online ahead of print.
PubMed 29305409Torres S, Sticco N, Bosch JJ, Iolster T, Siaba A, Rocca Rivarola M, Schnitzler E. Effectiveness of magnesium sulfate as initial treatment of acute severe asthma in children, conducted in a tertiary-level university hospital: a randomized, controlled trial. Arch Argent Pediatr. 2012 Aug;110(4):291-6. doi: 10.5546/aap.2012.eng.291. English, Spanish.
PubMed 22859321Rowe BH, Bretzlaff JA, Bourdon C, Bota GW, Camargo CA Jr. Magnesium sulfate for treating exacerbations of acute asthma in the emergency department. Cochrane Database Syst Rev. 2000;2000(2):CD001490. doi: 10.1002/14651858.CD001490.
PubMed 10796650