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

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ClinicalTrials.gov Identifier: NCT02588963
Recruitment Status : Unknown
Verified March 2016 by Ana Silva Alexandrino, Polytechnic Institute of Porto.
Recruitment status was:  Active, not recruiting
First Posted : October 28, 2015
Last Update Posted : March 29, 2016
Sponsor:
Collaborator:
Aveiro University
Information provided by (Responsible Party):
Ana Silva Alexandrino, 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.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Other: Health education session Other: Nasal clearance Protocol Other: Control Not Applicable

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  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Respiratory Infections Among Children Under 3 Years of Age Attending
Study Start Date : January 2015
Actual Primary Completion Date : September 2015
Estimated Study Completion Date : December 2016

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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)


Other Outcome Measures:
  1. 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. 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.

  3. Health resources [ Time Frame: 1 month ]
    frequency of use of health resources and/or medication

  4. Absenteeism [ Time Frame: 1 month ]
    number of days that the child were absent at the daycare and/or caregivers were absent at work;



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Ages Eligible for Study:   3 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588963


Locations
Portugal
School of Allied Health Technologies of the Polytechnic Institute of Porto
Vila Nova de Gaia, Portugal, 4400-330
Sponsors and Collaborators
Polytechnic Institute of Porto
Aveiro University
Investigators
Principal Investigator: Ana S Alexandrino, MSc School of Allied Health Technologies of the Polytechnic Institute of Porto

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ana Silva Alexandrino, MSc, Polytechnic Institute of Porto
ClinicalTrials.gov Identifier: NCT02588963     History of Changes
Other Study ID Numbers: PIPorto
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ana Silva Alexandrino, Polytechnic Institute of Porto:
upper respiratory tract infections
lower respiratory tract infections
health promotion
respiratory physiotherapy
infant

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases