Prevention of Respiratory Infections Among Children Under 3 Years of Age Attending Daycare Centres
- Conditions
- Respiratory Tract Infections
- Interventions
- Other: Health education sessionOther: ControlOther: Nasal clearance Protocol
- Registration Number
- NCT02588963
- Lead Sponsor
- Polytechnic Institute of Porto
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
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
Children born prematurely, with lower respiratory infections, with chronic neurological, musculoskeletal, cardiac or respiratory disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Experimental Group 1 Health education session Children whose caregivers were subjected to a health education session Experimental Group 3 Nasal clearance Protocol Children whose caregivers were subjected to health education session and who were subjected to respiratory physiotherapy protocol Control Group Control Children who were not subjected to respiratory physiotherapy protocol for nasal clearance and whose parents were not subjected to health education session Experimental Group 2 Nasal clearance Protocol Children who were subjected to nasal clearance protocol Experimental Group 3 Health education session Children whose caregivers were subjected to health education session and who were subjected to respiratory physiotherapy protocol
- Primary Outcome Measures
Name Time Method Health Indicators 1 month after intervention health status of the child was reported by caregivers concerning the number of episodes of respiratory infections and/or otitis.
- Secondary Outcome Measures
Name Time Method Middle Ear Condition 1 month Pressure, compliance and tympanogram of the middle ear were assessed by tympanometry, performed by an audiologist (Hand Held Impedance Audiometer MT10 (Interacoustics1 USA) calibrated on November 22, 2010, according to Food and Drug Administration (FDA) requirements, with a 226 Hz probe tone)
Nasal Auscultation 1 month Pressure, compliance and tympanogram of the middle ear were assessed by tympanometry, performed by an audiologist (Hand Held Impedance Audiometer MT10 (Interacoustics1 USA) calibrated on November 22, 2010, according to Food and Drug Administration (FDA) requirements, with a 226 Hz probe tone)
Severity of respiratory infection 1 month Paediatric Respiratory Severity Score (PRSS) adapted for the Portuguese culture (Cronbach's alpha = 0.80 and ICC 2,1 = 0.91) was used to assess the child's respiratory clinical parameters, such as dyspnea, breathing sounds, adventitious sounds, daily expectoration, cough, nutrition, fever and rhinorrhea.
Trial Locations
- Locations (1)
School of Allied Health Technologies of the Polytechnic Institute of Porto
🇵🇹Vila Nova de Gaia, Portugal