Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06176664
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-12-06
Brief Title:
Oxygen Therapy for Children With Moderate Hypoxemia in Malawi
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Oxygen Therapy for Children With Moderate Hypoxemia in Malawi Pilot Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NoGoLoo
Brief Summary:
The goal of this pilot clinical trial is to compare standard of care low-flow oxygen and high-flow nasal canula oxygen in pediatric patients aged 1-59 months with pneumonia and an oxygen saturation of 90-93 in Malawi The main question it aims to answer is
Does the protocol for the randomized control trial work well
Can the researchers safely conduct the protocol for the trial
Participants will be randomly assigned to one of the three groups normal care without oxygen low-flow oxygen and high-flow nasal cannula oxygen and treated with that therapy in the hospital Researchers will look at the ability to safely conduct each part of the study
Does the protocol for the randomized control trial work well
Can the researchers safely conduct the protocol for the trial
Participants will be randomly assigned to one of the three groups normal care without oxygen low-flow oxygen and high-flow nasal cannula oxygen and treated with that therapy in the hospital Researchers will look at the ability to safely conduct each part of the study
Detailed Description:
Pneumonia is the leading infectious cause of under 5-year-old deaths globally and responsible for gt50 of deaths in Africa The World Health Organization WHO defines low blood oxygen saturation SpO2 levels hypoxemia as 90 Hypoxemia is identified in 31 of child pneumonia cases in Africa and is a key marker of elevated mortality risk When children are hypoxemic the WHO recommends oxygen treatment Importantly the WHO threshold of 90 for hypoxemia was based on concerns over limited oxygen supply and hospital over-crowding in low- and middle-income countries LMICs rather than quality evidence In most LMICs low oxygen flow is the mainstay of oxygen delivery Recently in high-income settings high-flow nasal cannula HFNC oxygen has emerged as a safe and effective alternative HFNC oxygen delivers higher flow warmed humidified gas via nasal prongs to reverse hypoxemia and potentially improve outcomes
Recent evidence challenges whether the WHO 90 hypoxemia threshold is optimal for identifying all children at higher risk of mortality in LMICs One meta-analysis from 13 LMICs reported 366-fold-higher odds of death 95 confidence interval CI 142 947 for children with a SpO2 93 The investigators research from Malawi and Bangladesh established children with pneumonia and SpO2 between 90-93 moderate hypoxemia is common and compared to higher SpO2 levels conveys higher mortality risk To date African children with a SpO2 90-93 are not recommended for oxygen treatment Observational data from Malawi found children with moderate hypoxemia and treated with oxygen had higher survival than those referred with a SpO2 90 Currently no randomized trials have determined whether low flow oxygen or HFNC oxygen treatment reduces the mortality of children with moderate hypoxemia SpO2 90-93 in African LMICs
Aim 1 Conduct a pilot open label three armed parallel randomized controlled trial RCT comparing standard care low-flow oxygen and HFNC oxygen for children with clinical pneumonia and a SpO2 90-93 to determine feasibility of a larger trial The investigators hypothesize it will be feasible to recruit randomize treat and safely follow-up all participants Children with SpO2 90-93 will be randomized 111 to standard care without oxygen controls low flow oxygen intervention 1 or HFNC oxygen intervention 2 The primary outcome will be feasibility defined as the proportion of enrolled children with 2 protocol violations Secondary outcomes include consent refusal intervention efficacy participant attrition and safety
Aim 2 Determine the prevalence of young Malawian children with a SpO2 90-93 at the designated study hospital The investigators hypothesize a SpO2 90-93 will be common among children presenting to the trial hospital The investigators will measure the SpO2 of all children under-five years old not limited to pneumonia cases presenting to the hospital 1 week per month over 12-months Conservatively assuming an average volume of 30 children per day based on prior data the investigators will generate 1400 SpO2 measurements
Recent evidence challenges whether the WHO 90 hypoxemia threshold is optimal for identifying all children at higher risk of mortality in LMICs One meta-analysis from 13 LMICs reported 366-fold-higher odds of death 95 confidence interval CI 142 947 for children with a SpO2 93 The investigators research from Malawi and Bangladesh established children with pneumonia and SpO2 between 90-93 moderate hypoxemia is common and compared to higher SpO2 levels conveys higher mortality risk To date African children with a SpO2 90-93 are not recommended for oxygen treatment Observational data from Malawi found children with moderate hypoxemia and treated with oxygen had higher survival than those referred with a SpO2 90 Currently no randomized trials have determined whether low flow oxygen or HFNC oxygen treatment reduces the mortality of children with moderate hypoxemia SpO2 90-93 in African LMICs
Aim 1 Conduct a pilot open label three armed parallel randomized controlled trial RCT comparing standard care low-flow oxygen and HFNC oxygen for children with clinical pneumonia and a SpO2 90-93 to determine feasibility of a larger trial The investigators hypothesize it will be feasible to recruit randomize treat and safely follow-up all participants Children with SpO2 90-93 will be randomized 111 to standard care without oxygen controls low flow oxygen intervention 1 or HFNC oxygen intervention 2 The primary outcome will be feasibility defined as the proportion of enrolled children with 2 protocol violations Secondary outcomes include consent refusal intervention efficacy participant attrition and safety
Aim 2 Determine the prevalence of young Malawian children with a SpO2 90-93 at the designated study hospital The investigators hypothesize a SpO2 90-93 will be common among children presenting to the trial hospital The investigators will measure the SpO2 of all children under-five years old not limited to pneumonia cases presenting to the hospital 1 week per month over 12-months Conservatively assuming an average volume of 30 children per day based on prior data the investigators will generate 1400 SpO2 measurements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None