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

Respiratory Tract Infections Clinical Trial

— PRICAD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02588963
• Other study ID #: PIPorto
• Status: Active, not recruiting
• Phase: N/A
• First received: October 23, 2015
• Last updated: March 28, 2016
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Polytechnic Institute of Porto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Research
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 36 Months

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Tract Infections

Intervention

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.
• 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.
• Control
Children proceeded to their normal activities at the daycare; Caregivers did not attend to education health session.

Locations

Country	Name	City	State
Portugal	School of Allied Health Technologies of the Polytechnic Institute of Porto	Vila Nova de Gaia

Sponsors (2)

Lead Sponsor	Collaborator
Polytechnic Institute of Porto	Aveiro University

Country where clinical trial is conducted

Portugal, 

References & Publications (6)

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. Review. — View 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. Epub 2012 Apr 12. — View 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. — View Citation

Postiaux G, Souza Pinto V, Vieira DR, Carvalho CM. Fisioterapia respiratória pediátrica: o tratamento guiado por ausculta pulmonar. Porto Alegre: Artmed Editora; 2004.

Santos R, Alexandrino AS, Tomé D, Melo C, Montes AM, Costa D, Ferreira JP. Inter and intra- rater reliability of nasal auscultation in daycare children? Minerva Pediatr. 2015 Sep 11. [Epub ahead of print] — View Citation

Tomé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregivers' Anxiety	Portuguese Version of the Self-rating Zung's Anxiety Scale (r=0,782; ICC=0,95) was applied to caregivers	2 months	No
Other	Caregivers' Knowledge about Respiratory Infections	Written evaluation form was applied to caregivers in order to assess their knowledge about respiratory infections, designed by an expert panel.	2 months	No
Other	Health resources	frequency of use of health resources and/or medication	1 month	No
Other	Absenteeism	number of days that the child were absent at the daycare and/or caregivers were absent at work;	1 month	No
Primary	Health Indicators	health status of the child was reported by caregivers concerning the number of episodes of respiratory infections and/or otitis.	1 month after intervention	No
Secondary	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.	1 month	No
Secondary	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)	1 month	Yes
Secondary	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)	1 month	Yes