Respiratory Tract InfectionsPRICADNCT02588963
Prevention of Respiratory Infections Among Children Under 3 Years of Age Attending Daycare Centres
A study testing Health education session and Nasal clearance Protocol in people with Respiratory Tract Infections, run by Polytechnic Institute of Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 36 months
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- Health education session and Nasal clearance Protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 36 months
- All sexes
- No healthy volunteers
- Child
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
Trial locations and contacts
1 site in 1 country.
Portugal1 site
School of Allied Health Technologies of the Polytechnic Institute of Porto
Vila Nova de Gaia, 4400-330
About this study
Official title: 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.
Read the 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.
- Conditions
- Respiratory Tract Infections
- Being tested
- Health education session, Nasal clearance Protocol, Control
- Keywords
- upper respiratory tract infections, lower respiratory tract infections, health promotion, respiratory physiotherapy, infant
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education sessionOther
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.
Nasal clearance ProtocolOther
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.
ControlOther
Children proceeded to their normal activities at the daycare; Caregivers did not attend to education health session.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | Children whose caregivers were subjected to a health education session Receives: Other: Health education session |
| Experimental Group 2 | Experimental | Children who were subjected to nasal clearance protocol Receives: Other: Nasal clearance Protocol |
| Experimental Group 3 | Experimental | Children whose caregivers were subjected to health education session and who were subjected to respiratory physiotherapy protocol Receives: Other: Health education session; Other: Nasal clearance Protocol |
| Control Group | Placebo comparator | Children who were not subjected to respiratory physiotherapy protocol for nasal clearance and whose parents were not subjected to health education session Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Indicators
health status of the child was reported by caregivers concerning the number of episodes of respiratory infections and/or otitis.
Measured: 1 month after intervention
Secondary outcomes (3)
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.
Measured: 1 month
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)
Measured: 1 month
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)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polytechnic Institute of Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Aveiro University
- Responsible party
- Principal investigator, Ana Silva Alexandrino, Polytechnic Institute of Porto
- Investigators
- Ana S Alexandrino, MSc, Principal investigator, School of Allied Health Technologies of the Polytechnic Institute of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588963
- Sponsor's protocol ID
- PIPorto
- Acronym
- PRICAD
- Status last verified
- Mar 2016
- First submitted
- 23 Oct 2015
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 23890343Cabral 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.
PubMed 24708839Gomes 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.
PubMed 22499404Postiaux G, Souza Pinto V, Vieira DR, Carvalho CM. Fisioterapia respiratória pediátrica: o tratamento guiado por ausculta pulmonar. Porto Alegre: Artmed Editora; 2004.
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.
PubMed 25441605Santos 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.
PubMed 26365822Alexandrino 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.
PubMed 27131288
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Respiratory Infections Among Children Under 3 Years of Age Attending
- ClinicalTrials.gov ID
- NCT02588963
- Acronym / sponsor ID
- PRICAD / PIPorto
- Conditions
- Respiratory Tract Infections
- Keywords
- upper respiratory tract infections, lower respiratory tract infections, health promotion, respiratory physiotherapy, infant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Polytechnic Institute of PortoUniversity, hospital or other
- Collaborators
- Aveiro University
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Other: Health education sessionChildren whose caregivers were subjected to a health education session |
| Experimental Group 2 | Experimental | Other: Nasal clearance ProtocolChildren who were subjected to nasal clearance protocol |
| Experimental Group 3 | Experimental | Other: Health education session, Other: Nasal clearance ProtocolChildren whose caregivers were subjected to health education session and who were subjected to respiratory physiotherapy protocol |
| Control Group | Placebo comparator | Other: ControlChildren who were not subjected to respiratory physiotherapy protocol for nasal clearance and whose parents were not subjected to health education session |
Who may qualify
- Ages
- 3 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health education sessionIt 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 | Experimental Group 1, Experimental Group 3 |
| Nasal clearance ProtocolNasal 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. | Other | Experimental Group 2, Experimental Group 3 |
| ControlChildren proceeded to their normal activities at the daycare; Caregivers did not attend to education health session. | Other | Control Group |
Primary outcome
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.
3 secondary outcomes
Severity of respiratory infection
Time frame: 1 month
Middle Ear Condition
Time frame: 1 month
Nasal Auscultation
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Background: PubMed 23890343Ingram 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.
- Background: PubMed 24708839Cabral 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.
- Background: PubMed 22499404Gomes 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.
- BackgroundPostiaux G, Souza Pinto V, Vieira DR, Carvalho CM. Fisioterapia respiratória pediátrica: o tratamento guiado por ausculta pulmonar. Porto Alegre: Artmed Editora; 2004.
- Background: PubMed 25441605Tome 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.
- Background: PubMed 26365822Santos 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.
- Derived from this study: PubMed 27131288Alexandrino 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana S Alexandrino, MSc principal investigator
School of Allied Health Technologies of the Polytechnic Institute of Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education session and Nasal clearance Protocol in people with Respiratory Tract Infections, run by Polytechnic Institute of Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Indicators (time frame: 1 month after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02588963, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2016.