Infant Conditions, Respiratory Insufficiency
Conditions
Keywords
Infant, Respiration
Brief summary
Children who are in a hospital with respiratory distress often have difficulty breathing, have thick mucus, and may find it hard to eat normally. Sometimes physical therapy is used to treat these children, but it is not entirely known which methods help the children's condition. The aim of this study is to evaluate the most common physiotherapy treatment method that is currently in use in Sweden for infants who are hospitalized with a lower respiratory infection.
Detailed description
All children under 2 years of age who are admitted to the hospital for a respiratory infection and who have previously been essentially healthy are asked to participate. The infants will be randomized to 3 groups, 1 control group and 2 intervention groups. The infants in the control group will receive the standard care at the clinic. In one intervention group the parents will receive instructions how to vary their child body position regularly, and in the other intervention group the child will receive physiotherapy regularly and the parents will carry out some treatment. Further actions in the form of inhalations or stimulation of deep breathing, will be used when needed. The children will be observed following a structured observational protocol regularly throughout the hospital stay.
Interventions
OTHERNon-individualized
Comparing two experimental interventions with standard care
OTHERIndividualized
Comparing two experimental interventions with standard care
Sponsors
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Randomisation is carried out with sealed envelopes that are only opened just before intervention starts. There are different care givers who carry out the observations and who perform the interventions.
Intervention model description
Comparison of tree parallel groups, 1 control and 2 intervention groups.
Eligibility
Sex/Gender
ALL
Age
0 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
* Infants hospitalized because of respiratory infections such as bronchiolitis, pneumonia or other airway obstructions. * Age 0-24 months * Born in gestation week 35 or later. * Guardians understand written Swedish, English, Arabic or Persian
Exclusion criteria
* Previous cardiac or respiratory disease * hospitalized more than 24 hours on this occasion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to improvement | Baseline, after 20 minutes, and every third hour up to discharge from hospital, no more than two weeks | First improvement regarding any of the following: Wang respiratory score, use of supplemented oxygen, use of supplemented high air flow, use of tube feeding, hospital stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| oxygen saturation | Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes | Change in percutanous oxygen saturation measured by probe on the foot |
| respiratory rate | Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes | Change in manually counted RR during one minute |
| Heart rate | Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes | Change in pulse oximeter |
| General condition, parents' assessment | Baseline and every third hour up to discharge from hospital, no more than two weeks | Time to the first reduction in Numeric Rating Scale 0-10, (0 the best, 10 the worst) |
| Lung complications | At discharge from the ward, no more than two weeks | Referral to an intensive care unit |
Countries
Sweden
Contacts
Primary ContactSonja Andersson Marforio, MSc
Backup ContactEva Ekvall Hansson, PhD
Outcome results
None listed