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

Spaarne Gasthuis

Status: Enrolling

Conditions: Bronchiolitis; Lower Respiratory Tract Infection; Bronchial Hyperreactivity

Treatments: Other: Oxygen saturation threshold

Study type: Interventional

Funder types: Other

Identifiers

NCT06016244

2023-504817-56 (Other Identifier)

2022.0100

Details and patient eligibility

About

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?

Enrollment: 560 estimated patients

Sex: All

Ages: 6 weeks to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

560 participants in 2 patient groups

88% oxygen saturation threshold

Experimental group

Description:

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

Treatment:

Other: Oxygen saturation threshold

92% oxygen saturation threshold

Active Comparator group

Description:

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

Treatment:

Other: Oxygen saturation threshold