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Childhood PneumoniaNCT03750747

Assessing the Feasibility and Effectiveness of Introducing Pulse Oximetry in IMCI Services

A study testing Pulse Oximeter in people with Childhood Pneumonia and Hypoxemia, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of the study is to assess the feasibility, acceptability and operational challenges of introducing Pulse Oximeter (PO) in IMCI services to manage acute respiratory infections at first-level primary care facilities in Bangladesh (phase 1). Read more about this study

Who is it for?
Ages 2 to 59 months
Conditions the study is for
Childhood Pneumonia, Hypoxemia
What is being tested?
Pulse Oximeter
Could I receive a placebo?
No, everyone receives an active treatment
How many people
612 participants
Where
1 siteBangladesh
Study dates
1 Dec 2018to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

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 2 to 59 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Sick children aged 2 to 59 months
  • Presenting with cough or difficult breathing
  • Receiving IMCI services in the selected facilities will be enrolled

Who cannot join

  • Severely ill children who need to be referred immediately
  • If the parents of the children are unwilling to participate

Trial locations and contacts

1 site in 1 country.

Shams El Arifeen, DrPH contact

+8801713366936

shams@icddrb.org

Bangladesh1 site, 1 recruiting

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    Dhaka, 1212

    Recruiting

Other trials in Bangladesh

About this study

Official title: Assessing the Feasibility and Effectiveness of Introducing Pulse Oximetry in IMCI Services to Manage Acute Respiratory Infections at First Level Health Facilities of Bangladesh

The purpose of the study is to assess the feasibility, acceptability and operational challenges of introducing Pulse Oximeter (PO) in IMCI services to manage acute respiratory infections at first-level primary care facilities in Bangladesh (phase 1). The investigators will also evaluate the effectiveness and cost-effectiveness of introducing PO in IMCI services at first level primary care health facilities (phase 2).

This study will employ a cluster randomized controlled trial design to evaluate the effectiveness of introducing PO in IMCI services (phase-2 objective). The feasibility assessment (phase-1 objective) will be nested within the larger effectiveness trail as internal piloting; which will help in generating evidence for designing a robust phase-2 trial. First-level primary healthcare facilities providing IMCI services will be regarded as clusters and the unit of randomization. Sixteen first level primary care health facilities (UH\&FWC) will be randomly assigned to comparison and intervention facilities.

Read the detailed description

Background:

  1. Burden: Pneumonia is the leading cause of childhood mortality which accounts for 16% of all under-5 deaths in Bangladesh and globally. Most of these deaths happen in the developing countries, where WHO recommends adopting Integrated Management of Childhood Illness (IMCI) as a strategy for outpatient management of common childhood illnesses, including pneumonia, in these poor resource settings.
  2. Knowledge gap: As per the IMCI guidelines, 'Pneumonia' can be treated through home-based management with oral antibiotics, whereas 'Severe Pneumonia' should be referred to high-level facilities for inpatient care. Previously, chest indrawing was considered as one of the signs of 'Severe Pneumonia.' In 2014, WHO revised the IMCI guidelines recommending chest indrawing as a sign of 'Pneumonia' instead of 'Severe Pneumonia.' A systematic review of the home-based management of chest indrawing 'Pneumonia' reported a treatment failure rate of 8.5% on day 6. This implies that some of the chest indrawing 'Pneumonia' cases will require special inpatient care in addition to oral antibiotics and home-based management as currently recommended by WHO.
  3. Relevance: Hypoxemia (SpO2<90%) is one of the strongest predictors of mortality due to pneumonia. Many of the chest indrawing 'Pneumonia' cases may have hypoxemia and need specialized inpatient care. In response to this, WHO recommended measuring SpO2 level with pulse oximetry (PO) as a part of IMCI services. As per the updated IMCI guidelines, any sick child (2-59 months) having SpO2 <90% should be referred for inpatient management, irrespective of its clinical classification. However, most of the primary care facilities are devoid of PO; and there is a paucity of evidence related to the feasibility and effectiveness of introducing of PO in primary care facilities.

Objectives:

  • Phase-1: To assess the feasibility, acceptability and operational challenges of introducing PO in IMCI services at first-level primary care health facilities in Bangladesh
  • Phase-2: To evaluate the effectiveness and cost-effectiveness of introducing PO in IMCI services at first level primary care health facilities in Bangladesh

Methods:

This study will employ a cluster randomized controlled trial design to evaluate the effectiveness of introducing PO in IMCI services (phase-2 objective). The feasibility assessment (phase-1 objective) will be nested within the larger effectiveness trail as an internal piloting; which will help in generating evidence for designing a robust phase-2 trial. First-level primary healthcare facilities providing IMCI services will be regarded as clusters and the unit of randomization. Twenty-four first level primary care health facilities will be randomly assigned to comparison and intervention facilities.

In phase-1, the feasibility, acceptability and operational challenges of introducing PO in IMCI services will be assessed in the intervention facilities. Structured observation of the use of PO in IMCI services and community case tracking will be conducted to address the phase-1 objective. Rigorous process documentation and qualitative method of data collection will be employed to document the process of implementation and assess implementation outcomes.

In phase-2, effectiveness will be assessed through community case tracking in both comparison and intervention facilities. Treatment failure rate will be the primary outcome and the analysis will consider 'intention to treat' approach. In addition, activity-based costing method will be adopted for collecting cost-related data.

Outcome measures/variables:

This study will assess the effectiveness of integrating PO in IMCI services in first-level health facilities in Bangladesh. PO will be able to identify children who are classified as 'Pneumonia' based on history and clinical signs but have hypoxaemia. It will facilitate referral of children with hypoxaemia to higher level facilities.

Being tested
Pulse Oximeter
Keywords
IMCI services, Pulse Oximeter, Acute respiratory infections, Implementation research, Hypoxaemia, Childhood Pneumonia, Resource poor settings
Medical subject headings
Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulse OximeterDevice

    SpO2 will be measured using a handheld PO device (selected for this study) applying the low noise cabled sensor. For patients weighing <10 kg, the sensor will be placed on the big toe. For patients weighing >10 kg, the sensor will be placed on an index finger. In case of failure in the first attempt, the alternate toe or index finger will be tried (second attempt). First, the sensor will be placed on toe or index finger and then the PO will be powered-on. A stable Sp02 reading will be considered to be obtained if SpO2 reading is stable by ±1 % for at least 10 seconds and the device signal strength is displayed to be adequate (green signal). Second attempt will be warranted if a stable reading is not obtaining within 1-2 minutes.

Study groups in NCT03750747
Study groupRoleWhat they receive
Intervention (Pulse Oximeter)ExperimentalThe intervention facilities will provide IMCI services with PO in addition to following existing IMCI guidelines. The IMCI service providers will classify and treat children presenting with cough and difficult breathing based on history and clinical signs. In addition, they will use PO to measure the SpO2 status of the sick children. Children clinically classified as 'Pneumonia' but having SpO2<90% will be referred to higher-level facilities for in-patient management. Only the children clinically classified 'Pneumonia' and having SpO2>90% will be treated through home-based management with oral antibiotics (amoxicillin, twice daily for five day).
Receives: Device: Pulse Oximeter
ComparisonNo interventionThe comparison facilities will continue providing routine IMCI services as per the existing guidelines. In routine IMCI services, IMCI service providers classify and treat children presenting with cough and difficult breathing based on history and clinical signs only. In routine IMCI services in Bangladesh, PO has not been introduced. Therefore, in the comparison facilities all children clinically classified as 'Pneumonia' will be treated through home-based management with oral antibiotics (amoxicillin, twice daily for five day)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment failure rate

    The primary outcome of interest is treatment failure rate among those who are clinically classified as 'Pneumonia'. Operational definition of treatment failure will be finalized based on expert consultation and opinion of the caretakers of sick children through PPI. For illustrative purpose, an operational definition of the treatment failure is presented below which is based on some similar studies, i.e. SAT, AFRINEST, NO-SHOT, etc.Presence of any of the followings signs on day-6 and day-12 will be a considered as treatment failure:

    • Death
    • Appearance of any of the danger signs:
    • Inability to drink
    • Vomits everything
    • Lethargy or unconsciousness
    • Convulsions or history of convulsion
    • Persistence of
    • Low oxygen saturation (SpO2<90%)
    • Chest indrawing
    • Fast breathing

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2018
  2. Study start1 Dec 2018
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
612 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03750747
Sponsor's protocol ID
PR-18054
Status last verified
Feb 2022
First submitted
14 Nov 2018
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Confidentiality of the data will be ensured at all steps of the study including data collection, data management, access to data and use of the information. All personal identifiers will be removed from the data prior to analysis.

Publications

  • Liu L, Oza S, Hogan D, Chu Y, Perin J, Zhu J, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of under-5 mortality in 2000-15: an updated systematic analysis with implications for the Sustainable Development Goals. Lancet. 2016 Dec 17;388(10063):3027-3035. doi: 10.1016/S0140-6736(16)31593-8. Epub 2016 Nov 11.

    PubMed 27839855

  • Lim YW, Steinhoff M, Girosi F, Holtzman D, Campbell H, Boer R, Black R, Mulholland K. Reducing the global burden of acute lower respiratory infections in children: the contribution of new diagnostics. Nature. 2006 Nov 23;444 Suppl 1:9-18. doi: 10.1038/nature05442. No abstract available.

    PubMed 17159890

  • Sazawal S, Black RE; Pneumonia Case Management Trials Group. Effect of pneumonia case management on mortality in neonates, infants, and preschool children: a meta-analysis of community-based trials. Lancet Infect Dis. 2003 Sep;3(9):547-56. doi: 10.1016/s1473-3099(03)00737-0.

    PubMed 12954560

  • Arifeen SE, Hoque DM, Akter T, Rahman M, Hoque ME, Begum K, Chowdhury EK, Khan R, Blum LS, Ahmed S, Hossain MA, Siddik A, Begum N, Sadeq-ur Rahman Q, Haque TM, Billah SM, Islam M, Rumi RA, Law E, Al-Helal ZA, Baqui AH, Schellenberg J, Adam T, Moulton LH, Habicht JP, Scherpbier RW, Victora CG, Bryce J, Black RE. Effect of the Integrated Management of Childhood Illness strategy on childhood mortality and nutrition in a rural area in Bangladesh: a cluster randomised trial. Lancet. 2009 Aug 1;374(9687):393-403. doi: 10.1016/S0140-6736(09)60828-X.

    PubMed 19647607

  • Chowdhury EK, El Arifeen S, Rahman M, Hoque DE, Hossain MA, Begum K, Siddik A, Begum N, Sadeq-ur Rahman Q, Akter T, Haque TM, Al-Helal ZM, Baqui AH, Bryce J, Black RE. Care at first-level facilities for children with severe pneumonia in Bangladesh: a cohort study. Lancet. 2008 Sep 6;372(9641):822-30. doi: 10.1016/S0140-6736(08)61166-6. Epub 2008 Aug 18.

    PubMed 18715634

  • Armstrong Schellenberg JR, Adam T, Mshinda H, Masanja H, Kabadi G, Mukasa O, John T, Charles S, Nathan R, Wilczynska K, Mgalula L, Mbuya C, Mswia R, Manzi F, de Savigny D, Schellenberg D, Victora C. Effectiveness and cost of facility-based Integrated Management of Childhood Illness (IMCI) in Tanzania. Lancet. 2004 Oct 30-Nov 5;364(9445):1583-94. doi: 10.1016/S0140-6736(04)17311-X.

    PubMed 15519628

  • Owais A, Sultana S, Stein AD, Bashir NH, Awaldad R, Zaidi AK. Why do families of sick newborns accept hospital care? A community-based cohort study in Karachi, Pakistan. J Perinatol. 2011 Sep;31(9):586-92. doi: 10.1038/jp.2010.191. Epub 2011 Jan 27.

    PubMed 21273989

  • Peterson S, Nsungwa-Sabiiti J, Were W, Nsabagasani X, Magumba G, Nambooze J, Mukasa G. Coping with paediatric referral--Ugandan parents' experience. Lancet. 2004 Jun 12;363(9425):1955-6. doi: 10.1016/S0140-6736(04)16411-8.

    PubMed 15194257

  • Addo-Yobo E, Chisaka N, Hassan M, Hibberd P, Lozano JM, Jeena P, MacLeod WB, Maulen I, Patel A, Qazi S, Thea DM, Nguyen NT. Oral amoxicillin versus injectable penicillin for severe pneumonia in children aged 3 to 59 months: a randomised multicentre equivalency study. Lancet. 2004 Sep 25-Oct 1;364(9440):1141-8. doi: 10.1016/S0140-6736(04)17100-6.

    PubMed 15451221

  • Hazir T, Fox LM, Nisar YB, Fox MP, Ashraf YP, MacLeod WB, Ramzan A, Maqbool S, Masood T, Hussain W, Murtaza A, Khawar N, Tariq P, Asghar R, Simon JL, Thea DM, Qazi SA; New Outpatient Short-Course Home Oral Therapy for Severe Pneumonia Study Group. Ambulatory short-course high-dose oral amoxicillin for treatment of severe pneumonia in children: a randomised equivalency trial. Lancet. 2008 Jan 5;371(9606):49-56. doi: 10.1016/S0140-6736(08)60071-9.

    PubMed 18177775

  • Straus WL, Qazi SA, Kundi Z, Nomani NK, Schwartz B. Antimicrobial resistance and clinical effectiveness of co-trimoxazole versus amoxycillin for pneumonia among children in Pakistan: randomised controlled trial. Pakistan Co-trimoxazole Study Group. Lancet. 1998 Jul 25;352(9124):270-4. doi: 10.1016/s0140-6736(97)10294-x.

    PubMed 9690406

  • Addo-Yobo E, Anh DD, El-Sayed HF, Fox LM, Fox MP, MacLeod W, Saha S, Tuan TA, Thea DM, Qazi S; Multicenter Amoxicillin Severe pneumonia Study (MASS) Group. Outpatient treatment of children with severe pneumonia with oral amoxicillin in four countries: the MASS study. Trop Med Int Health. 2011 Aug;16(8):995-1006. doi: 10.1111/j.1365-3156.2011.02787.x. Epub 2011 May 4.

    PubMed 21545381

  • Atkinson M, Lakhanpaul M, Smyth A, Vyas H, Weston V, Sithole J, Owen V, Halliday K, Sammons H, Crane J, Guntupalli N, Walton L, Ninan T, Morjaria A, Stephenson T. Comparison of oral amoxicillin and intravenous benzyl penicillin for community acquired pneumonia in children (PIVOT trial): a multicentre pragmatic randomised controlled equivalence trial. Thorax. 2007 Dec;62(12):1102-6. doi: 10.1136/thx.2006.074906. Epub 2007 Jun 13.

    PubMed 17567657

  • Ayieko P, English M. Case management of childhood pneumonia in developing countries. Pediatr Infect Dis J. 2007 May;26(5):432-40. doi: 10.1097/01.inf.0000260107.79355.7d.

    PubMed 17468655

  • Bari A, Sadruddin S, Khan A, Khan Iu, Khan A, Lehri IA, Macleod WB, Fox MP, Thea DM, Qazi SA. Community case management of severe pneumonia with oral amoxicillin in children aged 2-59 months in Haripur district, Pakistan: a cluster randomised trial. Lancet. 2011 Nov 19;378(9805):1796-803. doi: 10.1016/S0140-6736(11)61140-9. Epub 2011 Nov 10.

    PubMed 22078721

Questions about this trial

What is this clinical trial studying?

A study testing Pulse Oximeter in people with Childhood Pneumonia and Hypoxemia, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shams El Arifeen, DrPH (+8801713366936, shams@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment failure rate (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03750747, which also lists 53 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.

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