Prevention of Respiratory Infections Among Children Under 3 Years of Age Attending Daycare Centres (PRICAD)

Polytechnic Institute of Porto

Status: Unknown

Conditions: Respiratory Tract Infections

Treatments: Other: Nasal clearance Protocol; Other: Control; Other: Health education session

Study type: Interventional

Funder types: Other

Identifiers

NCT02588963

PIPorto

Details and patient eligibility

About

The aim of this study is to evaluate the influence of Primary and Secondary Prevention of Respiratory Infections in children up to 3 years-old attending daycare.

Full description

Randomized controlled clinical trial including children up-to 3 years-old who attend daycare centres in O Porto.

To evaluate the Primary Prevention of Respiratory infections it was created and ministered to children's caregivers an education health session, regarding the prevention of respiratory infections of children, according to caregivers needs.

It is known that parental perceptions influence their behaviour in respect to the care of their unwell child. Sometimes misunderstandings occurred because parents' expressions of concern or requests for additional information were sometimes perceived as a challenge to the clinicians' diagnosis or treatment decision, which leads to unnecessary and unwanted prescribing of antibiotics. Health professionals should provide consistent information that promotes parental self-efficacy in the care of their unwell child.

To evaluate the Secondary Prevention of Respiratory Infections it was applied to children with signs of upper respiratory infections (rhinorrhea, cough and nasal obstruction) a nasal clearance protocol, developed by Guy Postiaux. This protocol consists on the application of physiological serum in the nostrils of the child, followed by forced nasal inspiration. The protocol is applied for 3 consecutive days, according to established criteria suggested by Postiaux. This intervention is indicated on Upper Respiratory Infections, such as rhinitis or rhinopharyngitis, with large amount of secretions in the upper airway and it is an effective adjuvant for medication. Forced nasal inspiration is able to create sufficient gas velocity to act on the pressure of the middle ear, through the eustachian tube, and may have an important role in the prevention of otitis.

Enrollment: 200 patients

Sex: All

Ages: 3 to 36 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Children of both genders up to 3 years, born at term, pregnancy without complications, attending day care, residents in OPorto, with medical approval for intervention

Exclusion Criteria: Children born prematurely, with lower respiratory infections, with chronic neurological, musculoskeletal, cardiac or respiratory disorders

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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200 participants in 4 patient groups, including a placebo group

Experimental Group 1

Experimental group

Description:

Children whose caregivers were subjected to a health education session

Treatment:

Other: Health education session

Experimental Group 2

Experimental group

Description:

Children who were subjected to nasal clearance protocol

Treatment:

Other: Nasal clearance Protocol

Experimental Group 3

Experimental group

Description:

Children whose caregivers were subjected to health education session and who were subjected to respiratory physiotherapy protocol

Treatment:

Other: Health education session

Other: Nasal clearance Protocol

Control Group

Placebo Comparator group

Description:

Children who were not subjected to respiratory physiotherapy protocol for nasal clearance and whose parents were not subjected to health education session

Treatment:

Other: Control