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

Spaarne Gasthuis560 enrolled

Overview

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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

560

Conditions

Bronchiolitis Lower Respiratory Tract Infection Bronchial Hyperreactivity

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 6 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. Exclusion Criteria: * 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.

Locations (9)

Spaarne Gasthuis

Haarlem, North Holland, 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

Outcomes

Primary Outcomes

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.

Time frame: 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

Length of stay

Time from admission to discharge in hours

Time frame: During admission

Pediatric Intensive Care Unit (PICU) admissions

Number of PICU admissions per group

Time frame: During admission

Time on oxygen therapy

Time in hours spent on supplemental oxygen

Time frame: During admission

Duration of symptoms

Measured as days from admission to having met all of the following criteria: resolution of cough, resolution of dyspnea as indicated by parent, cessation of scheduled bronchodilator use.

Time frame: from admission to 90 days after discharge

Return to normal health

Measured as days from admission to parent reported normal health. Upon discharge parents/patients are asked to record the last day of illness and report this in the follow-up questionnaires

Time frame: from admission to 90 days after discharge

Time to return to school/daycare

Measured as days from admission to parent reported return to school/daycare

Time frame: from admission to 90 days after discharge

Unscheduled health care visits or admissions after discharge

Number of unscheduled visits or admissions up to 28 days after discharge

Time frame: from admission to 28 days after discharge

Patient quality of life

Measured by digital questionnaire of EQ-5D-Y (modified versions are used in agreement with EuroQol for patients \< 4 years)

Time frame: at discharge, 7, 28 and 90 days follow-up

Overall pediatric health

ICHOM PROMIS Pediatric Global Health set

Time frame: at discharge, 7, 28 and 90 days follow-up

Parental anxiety

by anxiety items of Hospital Anxiety and Depression Scale

Time frame: at discharge, 7 and 28 days follow-up

Economic evaluation

The aim of the economic evaluation is to relate the incremental costs of an SpO2 of 88% (intervention) in comparison with an SpO2 of 92% (control) to the incremental health effects. Both a cost-effectiveness analysis (CEA) and a cost-utility analysis (CUA) will be performed from a societal and healthcare perspective

Time frame: Up to 90 days after discharge

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

Overview

Conditions

Interventions

Eligibility

Locations (9)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts