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

March 28, 2016 updated by: Ana Silva Alexandrino, Polytechnic Institute of Porto

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Vila Nova de Gaia, Portugal, 4400-330
        • School of Allied Health Technologies of the Polytechnic Institute of Porto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group 1
Children whose caregivers were subjected to a health education session
Other: 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: Experimental Group 2
Children who were subjected to nasal clearance protocol
Other: 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: Experimental Group 3
Children whose caregivers were subjected to health education session and who were subjected to respiratory physiotherapy protocol
Other: 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.
Other: 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: Control Group
Children who were not subjected to respiratory physiotherapy protocol for nasal clearance and whose parents were not subjected to health education session
Other: Control
Children proceeded to their normal activities at the daycare; Caregivers did not attend to education health session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Indicators
Time Frame: 1 month after intervention
health status of the child was reported by caregivers concerning the number of episodes of respiratory infections and/or otitis.
1 month after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of respiratory infection
Time Frame: 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.
1 month
Middle Ear Condition
Time Frame: 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)
1 month
Nasal Auscultation
Time Frame: 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)
1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregivers' Anxiety
Time Frame: 2 months
Portuguese Version of the Self-rating Zung's Anxiety Scale (r=0,782; ICC=0,95) was applied to caregivers
2 months
Caregivers' Knowledge about Respiratory Infections
Time Frame: 2 months
Written evaluation form was applied to caregivers in order to assess their knowledge about respiratory infections, designed by an expert panel.
2 months
Health resources
Time Frame: 1 month
frequency of use of health resources and/or medication
1 month
Absenteeism
Time Frame: 1 month
number of days that the child were absent at the daycare and/or caregivers were absent at work;
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Polytechnic Institute of Porto

Collaborators

Aveiro University

Investigators

  • Principal Investigator: Ana S Alexandrino, MSc, School of Allied Health Technologies of the Polytechnic Institute of Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIPorto

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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