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

Launched by SPAARNE GASTHUIS · Aug 24, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the best level of oxygen in the blood for children who are having trouble breathing due to conditions like bronchiolitis or lower respiratory infections. The researchers want to find out if it’s better to maintain a lower limit of 88% or 92% oxygen saturation when giving extra oxygen to these children. The goal is to help them get better faster and to be able to go home sooner from the hospital.

To participate in this study, children between 6 weeks and 12 years old who are hospitalized for breathing issues and need supplemental oxygen may be eligible. Parents will fill out questionnaires during the hospital stay to help track the child’s recovery. It’s important to note that children with certain other health conditions or those who have been part of different studies will not be included. This trial is currently recruiting participants, and it aims to provide valuable information to improve care for children with respiratory distress.

Gender

ALL

Eligibility criteria

• 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.