Clinical trial NCT02588963: Prevention of Respiratory Infections Among Children Under 3 Years of Age Attending Daycare Centres
Official title: Prevention of Respiratory Infections Among Children Under 3 Years of Age Attending
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Tract Infections
Keywords: upper respiratory tract infections
lower respiratory tract infections
health promotion
respiratory physiotherapy
infant
Lead sponsor: Polytechnic Institute of Porto
Sponsor class: OTHER
Collaborators: name: Aveiro University
First posted: 2015-10-28
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Health Indicators
timeFrame: 1 month after intervention
Secondary outcomes:
measure: Severity of respiratory infection
timeFrame: 1 month
measure: Middle Ear Condition
timeFrame: 1 month
measure: Nasal Auscultation
timeFrame: 1 month
Other outcomes:
measure: Caregivers' Anxiety
timeFrame: 2 months
measure: Caregivers' Knowledge about Respiratory Infections
timeFrame: 2 months
measure: Health resources
timeFrame: 1 month
measure: Absenteeism
timeFrame: 1 month
Locations:
city: Vila Nova de Gaia
country: Portugal
facility: School of Allied Health Technologies of the Polytechnic Institute of Porto
Study officials:
affiliation: School of Allied Health Technologies of the Polytechnic Institute of Porto
name: Ana S Alexandrino, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ingram J, Cabral C, Hay AD, Lucas PJ, Horwood J; TARGET team. Parents' information needs, self-efficacy and influences on consulting for childhood respiratory tract infections: a qualitative study. BMC Fam Pract. 2013 Jul 28;14:106. doi: 10.1186/1471-2296-14-106.
citation: Cabral C, Horwood J, Hay AD, Lucas PJ. How communication affects prescription decisions in consultations for acute illness in children: a systematic review and meta-ethnography. BMC Fam Pract. 2014 Apr 8;15:63. doi: 10.1186/1471-2296-15-63.
citation: Gomes EL, Postiaux G, Medeiros DR, Monteiro KK, Sampaio LM, Costa D. Chest physical therapy is effective in reducing the clinical score in bronchiolitis: randomized controlled trial. Rev Bras Fisioter. 2012 Jun;16(3):241-7. doi: 10.1590/s1413-35552012005000018. Epub 2012 Apr 12.
citation: Postiaux G, Souza Pinto V, Vieira DR, Carvalho CM. Fisioterapia respiratória pediátrica: o tratamento guiado por ausculta pulmonar. Porto Alegre: Artmed Editora; 2004.
citation: Tome D, Alexandrino AM, Santos RI, de Melo MC, Costa DA, Ferreira JP. Characterization of middle-ear condition of Oporto daycare children up-to 3 years-old: a cross sectional study. Int J Pediatr Otorhinolaryngol. 2014 Dec;78(12):2132-5. doi: 10.1016/j.ijporl.2014.09.022. Epub 2014 Sep 30.
citation: Santos R, Silva Alexandrino A, Tome D, Melo C, Mesquita Montes A, Costa D, Pinto Ferreira J. Inter- and intra-rater reliability of nasal auscultation in daycare children. Minerva Pediatr. 2018 Feb;70(1):20-26. doi: 10.23736/S0026-4946.17.04355-9. Epub 2015 Sep 11.
citation: Alexandrino AS, Santos R, Melo C, Bastos JM. Impact of caregivers' education regarding respiratory infections on the health status of day-care children: a randomized trial. Fam Pract. 2016 Oct;33(5):476-81. doi: 10.1093/fampra/cmw029. Epub 2016 Apr 30.