Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201404000706382 Date of Approval: 15/11/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The use of chest physiotherapy in children hospitalised with pneumonia
Official scientific title The use of Assisted Autogenic Drainage in children with acute respiratory disease in a developing country
Brief summary describing the background and objectives of the trial Limited evidence is available on physiotherapy in children with pneumonia.In 1 observational and 1 non-controlled/-randomised study,a positive effect of physiotherapy is seen,but in 2 RCT's no positive effect is shown.Small sample sizes and the use of different intervention techniques in one study make it difficult to accept or reject physiotherapy in this population.This study aims to determine whether AAD is more effective than standard nursing care in hospitalised children with pneumonia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,pneumonia,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Chest Physiotherapy
Anticipated trial start date 02/12/2013
Actual trial start date 24/03/2014
Anticipated date of last follow up 31/07/2014
Actual Last follow-up date 30/11/2015
Anticipated target sample size (number of participants) 98
Actual target sample size (number of participants) 34
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
532/2013 Human Research Ethics Committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation by the use of a computer generated list of random numbers Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group standard nursing care daily Every child with pneumonia, admitted to the hospital will receive standard nursing care, which consist of oxygen support, changing position regularly and suction if necessary. 49 Active-Treatment of Control Group
Experimental Group standard nusing care + assisted autogenic drainage bi-daily 10 to 30 minutes Children will receive AAD with bouncing on a therapy ball. AAD is a passive form of Autogenic Drainge, which uses controlled breathing at 3 different lung volumes to evacuate mucus from the lungs. During AAD, the physiotherapist places his/her hands on the child's chest and manually adapts the child's breathing level. 49
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with ¿ acute bacterial lobar or bronchial pneumonia, ¿ aged between one month and eight years ¿ hospitalised in Red Cross War Memorial Children¿s Hospital, Cape Town ¿ tachypnoea (RR ¿ 20 breaths per minute (bpm) in children > five years, ¿ 40 bpm in children between one and five years, ¿ 50 bpm in children between two and 12 months, and ¿60 bpm in children < two months) ¿ fever and/or cough ¿ radiological confirmation of pneumonia ¿ clinically stable (unstable = on mechanical ventilation, on positive pressure ventilation, tachycardia (<1year = 160 beats/min, 1-2year = 150 beats/min, 3-4year = 140 beats/min, 5-12years = 120 beats/min) or inadequate blood pressure, altered mental status, oxygen saturation <90% on oxygen support; when a child has none of these symptoms, then he/she is considered clinically stable) -Active tuberculosis (TB), -Bronchiolitis, -Pneumocystis jirovecii pneumonia (suspected or proven), -Pleural effusion, -Recent pneumothorax in last three months, -Asthma, -Increased intracranial pressure, -Chest deformities, -Osteoporosis, -Severe hypoxia or distress (oxygen saturation < 90% on oxygen and clinical signs: cyanosis, weak cry, feeding problems and head nodding, nasal flaring). If the child has more than 3 signs of severe distress or hypoxia, it will be excluded. If the child has 3 or less signs it will be included if the child is clinically stable. -Cystic fibrosis (these children are standardly hospitalised for two weeks which influences the duration of hospitalisation), -Other chronic respiratory disease which require daily physiotherapy -Presence of an intercostal drain, -Currently receiving mechanical ventilation, -Thoracic or abdominal surgery in the preceding six months, -Severe heart defect -Premature: < 30 weeks of gestation, -Hospitalised for less than 2 days 1 Month(s) 8 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/11/2013 Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room E52-24 Old Main Building, Groote Schuur Hospital Observatory 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome duration of hospitalisation Measured at discharge: number of days from admission to discharge at the medical practitioner¿s prescription, or until day of death. If the child is discharged from the hospital in the morning, this will count for half a day, when the child is discharged in the afternoon or evening, a full day will be taken into account.
Secondary Outcome duration of fever Daily measurement of temperature At discharge, duration of fever expressed in days, according to nursing documentation
Secondary Outcome respiratory rate Measured at admission Measured at discharge In the intervention group: - RR measured before treatment - RR measured after treatment - RR measured 1hour after treatment (if possible)
Secondary Outcome lung function test (children >5years) Measured at admission Measured at discharge
Secondary Outcome oxygen saturation Measured at admission Measured at discharge In treatment group: - SaO2 measured before treatment - SaO2 measured during treatment - SaO2 measured after treamtent - SaO2 measured 1hour after treatment (if possible)
Secondary Outcome duration of supplemental oxygen Measured at discharge (in hours, based on nursing documentation)
Secondary Outcome atelectasis/collaps record when it occurs
Secondary Outcome progression of respiratory support Documented in nursing documentation
Secondary Outcome mortality rate Document when dead occurs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Red Cross War Memorial Children's Hospital Klipfontein Road Rondebosch 7700 South Africa
Dr. George Mukhari Academic Hospital 3111 Setlogelo Drive Ga-Rankuwa 0208 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Red Cross War Memorial Children's Hospital Klipfontein Road Rondebosch 7700 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town Bremner Building, Lovers' Walk Rondebosch 7700 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Brenda Morrow Red Cross War Memorial Children's Hospital,Klipfontein Road Rondebosch 7700 South Africa
Jennifer Jelsma UCT, division of physiotherapy, Groote Schuur Hospital, Old Main Building, Anzio Road Observatory 7925 South Africa
Lieselotte Corten Antwerpsesteenweg 474 Westmalle 2390 Belgium
Sameer Rahim Red Cross War Memorial Children's Hospital,Klipfontein Road Rondebosch 7700 South Africa
Rukaiya Mowzer Red Cross War Memorial Children's Hospital,Klipfontein Road Rondebosch 7700 South Africa
Anri Human Sefako Makgatho Health Sciences University, Molotlegi Street, Ga-Rankuwa Pretoria 0208 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Brenda Morrow brenda.morrow@uct.ac.za +27 21 658 5074 Red Cross War Memorial Children's Hospital, Klipfontein Road
City Postal code Country Position/Affiliation
Rondebosch 7700 South Africa Associate Professor
Role Name Email Phone Street address
Public Enquiries Lieselotte Corten crtlie001@myuct.ac.za +27 71 588 3729 Antwerpsesteenweg 474
City Postal code Country Position/Affiliation
Westmalle 2390 Belgium PhD-student
Role Name Email Phone Street address
Scientific Enquiries Brenda Morrow brenda.morrow@uct.ac.za +27 21 658 5074 Red Cross War Memorial Children's Hospital, Klipfontein Road
City Postal code Country Position/Affiliation
Rondebosch 7700 South Africa Associate Professor
REPORTING
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