Overview

This trial is active, not recruiting.

Condition respiratory tract infections
Treatments health education session, nasal clearance protocol, control
Sponsor Polytechnic Institute of Porto
Collaborator Aveiro University
Start date January 2015
End date September 2015
Trial size 200 participants
Trial identifier NCT02588963, PIPorto

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Children whose caregivers were subjected to a health education session
health education session
It was created an education health session regarding the prevention of respiratory infections of children, according to caregivers needs. This session have a theoretical component, addressing especially modifiable risk factors of respiratory infections in children, and a practical component where caregivers can learn and practice nasal clearance techniques, demonstrated by the physiotherapist.
(Experimental)
Children who were subjected to nasal clearance protocol
nasal clearance protocol
Nasal clearance protocol consists on the application of physiological serum in the nostrils of the child, followed by the stimulation of nasal inspiration in order to remove mucus from the nose and nasopharynx. The protocol is applied for 3 consecutive days, according to established criteria suggested by Postiaux.
(Experimental)
Children whose caregivers were subjected to health education session and who were subjected to respiratory physiotherapy protocol
health education session
It was created an education health session regarding the prevention of respiratory infections of children, according to caregivers needs. This session have a theoretical component, addressing especially modifiable risk factors of respiratory infections in children, and a practical component where caregivers can learn and practice nasal clearance techniques, demonstrated by the physiotherapist.
nasal clearance protocol
Nasal clearance protocol consists on the application of physiological serum in the nostrils of the child, followed by the stimulation of nasal inspiration in order to remove mucus from the nose and nasopharynx. The protocol is applied for 3 consecutive days, according to established criteria suggested by Postiaux.
(Placebo Comparator)
Children who were not subjected to respiratory physiotherapy protocol for nasal clearance and whose parents were not subjected to health education session
control
Children proceeded to their normal activities at the daycare; Caregivers did not attend to education health session.

Primary Outcomes

Measure
Health Indicators
time frame: 1 month after intervention

Secondary Outcomes

Measure
Severity of respiratory infection
time frame: 1 month
Middle Ear Condition
time frame: 1 month
Nasal Auscultation
time frame: 1 month

Eligibility Criteria

Male or female participants from 3 months up to 36 months old.

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

Additional Information

Official title Prevention of Respiratory Infections Among Children Under 3 Years of Age Attending
Principal investigator Ana S Alexandrino, MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Polytechnic Institute of Porto.