Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial

NCT06016244 | Recruiting DMC

• 2 other identifiers: 2022.01002023-504817-56
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 9

Brief Summary

The goal of this clinical trial is to find out at which lower limit for saturation (amount of oxygen in the blood) we can best give extra oxygen to children that have been admitted for shortness of breath. We hope to accomplish a shorter period of illness for these children and that they can be discharged home earlier. Participants will receive supplemental oxygen if their blood oxygen levels are below 88% or below 92%. After admission, (parents of) participating children will fill out questionnaires. We will compare the two groups on their hospitalization duration and recovery. In other words, is it better to maintain a lower limit of 88% saturation or a lower limit of 92% in children admitted for shortness of breath?

Conditions

Bronchiolitis; Lower Respiratory Tract Infection; Bronchial Hyperreactivity

Keywords

Oxygen saturation target; SpO2; Children

Outcome Measures

Primary Outcomes (1)

• Time to meeting all discharge criteria

  Time in hours from admission to meeting all discharge criteria Discharge criteria include: * No need for supplemental oxygen for 4 hours, including a period of sleep for children aged \< 2 years * Clinically fit for discharge with normal or minimally increased respiratory rate AND no or mild respiratory distress, as judged by nurses and physicians using the Parshuram et al scoring system, commonly used in Dutch paediatric practice as part of the Pediatric Early Warning Scale\]. * No need for in-hospital feeding or medication by nasogastric tube (NGT). * No need for in-hospital intravenous treatment. * No need for in-hospital nebulized bronchodilator treatment. * No need for in-hospital treatment with metered dose inhalator inhalations more often than every 3 hours. * No need for high flow delivered by high flow nasal cannula or nasal prongs.

  Discharge criteria are checked daily during admission up to discharge (generally a few days up to a week but longer if admission lasts longer) and the time and date at which all discharge criteria have been met will be recorded.

Secondary Outcomes (11)

• Length of stay

  During admission

• Pediatric Intensive Care Unit (PICU) admissions

  During admission

• Time on oxygen therapy

  During admission

• Duration of symptoms

  from admission to 90 days after discharge

• Return to normal health

  from admission to 90 days after discharge

Other Outcomes (2)

• Skin type influence

  Up to 90 days after discharge

• Time spent in 88%-92% window

  recorded at discharge based on monitoring data registered during admission, generally a few days to a week but longer if admission lasts longer.

Study Arms (2)

88% oxygen saturation threshold

EXPERIMENTAL

Patients in this arm will receive supplemental oxygen when SpO2 falls below 88% or when other clinical symptoms indicate a need for supplemental oxygen.

Other: Oxygen saturation threshold

92% oxygen saturation threshold

ACTIVE COMPARATOR

Patients in this arm will receive supplemental oxygen when SpO2 falls below 92% or when other clinical symptoms indicate a need for supplemental oxygen.

Other: Oxygen saturation threshold

Interventions

Oxygen saturation threshold OTHER

Oxygen saturation threshold on which supplemental oxygen is decided

88% oxygen saturation threshold; 92% oxygen saturation threshold

Eligibility Criteria

• Age: 6 Weeks - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• weeks to 12 years of age (corrected age for children with gestational age \< 37 weeks)
• hospitalized with respiratory distress due to bronchiolitis, viral wheeze or lower respiratory tract infection, as diagnosed by the treating physician. Viral wheeze can only be diagnosed below the age of 6 years.
• requiring supplemental oxygen as per usual care (SpO2 \<92% or for treating symptoms of respiratory distress as determined by the treating physician
• As respiratory distress in children with an asthma attack is mainly driven by hypoxia, they are at risk of undertreatment in the acute phase of the attack. Therefore, children aged 6-12 years of age with an asthma attack are excluded from this study.

You may not qualify if:

• children with, except for the studied diseases, pre-existing cardiopulmonary, neurological or hematological conditions (e.g. congenital thoracic malformation, airway malacia, post infectious bronchiolitis obliterans, childhood interstitial lung disease. primary immune deficiency)
• children born \<32 weeks gestational age
• children already included in other studies, which potentially interfere with this study
• children (of parents) without a stable internet connection needed for answering questionnaires
• children previously included in the current study
• considering questionnaires are only available in Dutch and English, children (of parents) with different languages will be excluded.

Sponsors & Collaborators

• Spaarne Gasthuis: lead

Study Sites (9)

Spaarne Gasthuis

Haarlem, North Holland, 2035 RC, Netherlands

RECRUITING

Canisius Wilhelmina Ziekenhuis

Arnhem, Netherlands

RECRUITING

Rijnstate Ziekenhuis

Arnhem, Netherlands

RECRUITING

Amphia Ziekenhuis

Breda, Netherlands

RECRUITING

Martini Ziekenhuis

Groningen, Netherlands

RECRUITING

Tergooi Ziekenhuis

Hilversum, Netherlands

RECRUITING

St Antonius Ziekenhuis

Nieuwegein, Netherlands

RECRUITING

Franciscus Gasthuis en Vlietland

Rotterdam, Netherlands

RECRUITING

Isala Klinieken

Zwolle, Netherlands

RECRUITING

Related Publications (1)

• Louman S, van Stralen KJ, Koppelman G, Vaessen-Verberne A, Bekhof J, Bosmans J, Brackel C, Kamps AWA, de Kleer I, Balemans W, Scheffer M, Brouwer M, van den Beukel M, Andrinopoulou ER, Pijnenburg MWH, Boehmer ALM. Safe, effective and cost-effective oxygen saturation targets for children and adolescents with respiratory distress: protocol for a randomised controlled trial (OxyKids study). BMJ Open. 2024 Dec 22;14(12):e087891. doi: 10.1136/bmjopen-2024-087891.

  PMID: 39806594 DERIVED

MeSH Terms

Conditions

Bronchiolitis; Bronchial Hyperreactivity

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Annmeie LM Boehmer, MD, PhD

  Spaarne Gasthuis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sam Louman, MD

CONTACT

+3123-2241645; slouman@spaarnegasthuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial, parallel group, block randomized and stratified by age and centre.

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 29, 2023
• Study Start: September 4, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: The data will only be made available for reuse after completion of the study and all planned publications of the results.
• Access Criteria: Other researchers will be able to find the metadata in the data repository. They could express their interest in the dataset through emailing the PI. After meeting the sharing and reuse conditions and approval of the PI, data access will be provided through the data repository.

Locations

NL (9)