Physiotherapy for Infants With Bronchiolities

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-23

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infant Conditions Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison of tree parallel groups, 1 control and 2 intervention groups.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

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.

Study Groups

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control group

The infants will receive the standard care at the ward.

Group Type NO_INTERVENTION

No interventions assigned to this group

Non-individualized

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.

Group Type EXPERIMENTAL

Non-individualized

Intervention Type OTHER

Comparing two experimental interventions with standard care

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.

Group Type EXPERIMENTAL

Individualized

Intervention Type OTHER

Comparing two experimental interventions with standard care

Interventions

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Non-individualized

Comparing two experimental interventions with standard care

Intervention Type OTHER

Individualized

Comparing two experimental interventions with standard care

Intervention Type OTHER

Eligibility Criteria

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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