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

Primary Purpose

Respiratory Tract Infections

Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Health education session
Nasal clearance Protocol
Control
Sponsored by
Polytechnic Institute of Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Tract Infections focused on measuring upper respiratory tract infections, lower respiratory tract infections, health promotion, respiratory physiotherapy, infant

Eligibility Criteria

3 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Allied Health Technologies of the Polytechnic Institute of Porto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Experimental Group 1

Experimental Group 2

Experimental Group 3

Control Group

Arm Description

Children whose caregivers were subjected to a health education session

Children who were subjected to nasal clearance protocol

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

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

Outcomes

Primary Outcome Measures

Health Indicators
health status of the child was reported by caregivers concerning the number of episodes of respiratory infections and/or otitis.

Secondary Outcome Measures

Severity of respiratory infection
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.
Middle Ear Condition
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
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)

Full Information

First Posted
October 23, 2015
Last Updated
March 28, 2016
Sponsor
Polytechnic Institute of Porto
Collaborators
Aveiro University
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1. Study Identification

Unique Protocol Identification Number
NCT02588963
Brief Title
Prevention of Respiratory Infections Among Children Under 3 Years of Age Attending Daycare Centres
Acronym
PRICAD
Official Title
Prevention of Respiratory Infections Among Children Under 3 Years of Age Attending
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Polytechnic Institute of Porto
Collaborators
Aveiro University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections
Keywords
upper respiratory tract infections, lower respiratory tract infections, health promotion, respiratory physiotherapy, infant

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group 1
Arm Type
Experimental
Arm Description
Children whose caregivers were subjected to a health education session
Arm Title
Experimental Group 2
Arm Type
Experimental
Arm Description
Children who were subjected to nasal clearance protocol
Arm Title
Experimental Group 3
Arm Type
Experimental
Arm Description
Children whose caregivers were subjected to health education session and who were subjected to respiratory physiotherapy protocol
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Children who were not subjected to respiratory physiotherapy protocol for nasal clearance and whose parents were not subjected to health education session
Intervention Type
Other
Intervention Name(s)
Health education session
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Nasal clearance Protocol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Children proceeded to their normal activities at the daycare; Caregivers did not attend to education health session.
Primary Outcome Measure Information:
Title
Health Indicators
Description
health status of the child was reported by caregivers concerning the number of episodes of respiratory infections and/or otitis.
Time Frame
1 month after intervention
Secondary Outcome Measure Information:
Title
Severity of respiratory infection
Description
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.
Time Frame
1 month
Title
Middle Ear Condition
Description
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)
Time Frame
1 month
Title
Nasal Auscultation
Description
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)
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Caregivers' Anxiety
Description
Portuguese Version of the Self-rating Zung's Anxiety Scale (r=0,782; ICC=0,95) was applied to caregivers
Time Frame
2 months
Title
Caregivers' Knowledge about Respiratory Infections
Description
Written evaluation form was applied to caregivers in order to assess their knowledge about respiratory infections, designed by an expert panel.
Time Frame
2 months
Title
Health resources
Description
frequency of use of health resources and/or medication
Time Frame
1 month
Title
Absenteeism
Description
number of days that the child were absent at the daycare and/or caregivers were absent at work;
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana S Alexandrino, MSc
Organizational Affiliation
School of Allied Health Technologies of the Polytechnic Institute of Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Allied Health Technologies of the Polytechnic Institute of Porto
City
Vila Nova de Gaia
ZIP/Postal Code
4400-330
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23890343
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.
Results Reference
background
PubMed Identifier
24708839
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.
Results Reference
background
PubMed Identifier
22499404
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.
Results Reference
background
Citation
Postiaux G, Souza Pinto V, Vieira DR, Carvalho CM. Fisioterapia respiratória pediátrica: o tratamento guiado por ausculta pulmonar. Porto Alegre: Artmed Editora; 2004.
Results Reference
background
PubMed Identifier
25441605
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.
Results Reference
background
PubMed Identifier
26365822
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.
Results Reference
background
PubMed Identifier
27131288
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.
Results Reference
derived

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

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