An interventional study of Non-individualized and Individualized in Infant Conditions and Respiratory Insufficiency, sponsored by Lund University. Status unknown at 2 sites in Sweden. Open to participants aged 0 Months to 24 Months. Per ClinicalTrials.gov, last updated 2021-09-30.
Sponsored by Lund University · Not applicable, Interventional, and Treatment
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.
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's planned enrollment of 120 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Lund University is the lead sponsor of 230 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The infants will receive the standard care at the ward.
The parents will be guided manually by the nursing staff and receive written information about how to change body positions of their child regularly throughout the hospital stay.
Other: Non-individualized
The infant will receive frequent changes of body positions, stimulation to physical activity, and stimulation to deep breathing while bouncing on a large ball in the arms of an adult. Additional light chest compressions and inhalations may be given. A physiotherapist will perform the intervention at least once daily, and the parents will be manually guided and receive written information about how to change body positions of their child regularly in a similar way throughout the hospital stay.
Other: Individualized
Comparing two experimental interventions with standard care
Comparing two experimental interventions with standard care
Time to improvement
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
Time frame: Baseline, after 20 minutes, and every third hour up to discharge from hospital, no more than two weeks
oxygen saturation
Change in percutanous oxygen saturation measured by probe on the foot
Time frame: Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
respiratory rate
Change in manually counted RR during one minute
Time frame: Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
Heart rate
Change in pulse oximeter
Time frame: Baseline and second assessment, directly following the first intervention (or interval) after 20 minutes
General condition, parents' assessment
Time to the first reduction in Numeric Rating Scale 0-10, (0 the best, 10 the worst)
Time frame: Baseline and every third hour up to discharge from hospital, no more than two weeks
Lung complications
Referral to an intensive care unit
Time frame: At discharge from the ward, no more than two weeks
Plan to share: No
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lund University