Pneumonia ChildhoodNCT06174454
Clinical Efficacy of Respiratory Pediatric Physiotherapy on a Child With Hospital Treated Pneumonia
A study testing Respiratory Pediatric Physiotherapy in people with Pneumonia Childhood and Rehabilitation, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
Trial summary
The accumulation of secretions in the bronchopulmonary air network promotes the detriment of respiratory functions generating hypoxia and causing a decrease in the cardiac output requiring the use of mechanical ventilation and hemodynamic support. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Pneumonia Childhood, Rehabilitation, Recovery of Function
- What is being tested?
- Respiratory Pediatric Physiotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteMexico
- Study dates
- 3 Feb 2018to 4 Nov 2023
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients from the Hospital Infantil de México Federico Góme with diagnosis of pneumonia (considering the diagnostic criteria of the WHO and the Guidelines for Nosocomial Pneumonia from the infectiology department.
- Patients aged 0 to 8 years old.
- A minimum HS of 72 hours.
- Having informed consent.
- Not having had previous RPP treatment.
Who cannot join
- Presenting a fever state for more than three days. Performing physiotherapy increases the body's peripheral temperature.
- Presenting an oxygen saturation below 80%.
- Requiring mechanical ventilation.
- Hemodynamic instability.
- Presenting systemic inflammatory response syndrome.
- Inotropic support.
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- Anatomical variants in the thorax.
- Unstable thorax.
- Esophageal atresia.
- Pleural effusion, pneumothorax.
- Alterations that compromise respiratory centers and/or the phrenic nerve.
- Neuromuscular diseases that compromise respiratory mechanics.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Infantil de México Federico Gómez
Mexico City, Delegación Cuauhtémoc, 06720
About this study
Official title: Clinical Efficacy of Respiratory Pediatric Physiotherapy on a Child With Hospital Treated Pneumonia: Single-Blind Clinical Trial
The accumulation of secretions in the bronchopulmonary air network promotes the detriment of respiratory functions generating hypoxia and causing a decrease in the cardiac output requiring the use of mechanical ventilation and hemodynamic support. It is intended to control the accumulation of secretions by means of Respiratory Pediatric Physiotherapy (RPP) and to evaluate its effectiveness counting on biological plausibility.
Read the detailed description
The OBJECTIVE of this research protocol is to evaluate the effectiveness of RPP compared to postural drainage plus compression to the muscle belly of the upper limbs, as an adjuvant treatment for children with pneumonia. It is expected that the clinical severity decreases by 1.5 in the Wang score (a modification of the Silverman score), with a standard deviation of 2.6 points and a decrease of two days in the hospital stay with a α 0.05 in a one-tail test, a P of 80% and a 95.5% confidence interval.
- Conditions
- Pneumonia Childhood, Rehabilitation, Recovery of Function
- Being tested
- Respiratory Pediatric Physiotherapy, Control Group
- Keywords
- Pneumonia, Respiratory Pediatric Physiotherapy
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Pediatric PhysiotherapyOther
Also called Fisioterapia torácica pediatrica
Prolonged slow expiration Tracheal pumping Controlled expiratory flow exercises Forced expiration technique
Control GroupOther
Will be subject to muscle compressions of the upper limbs. Both groups will receive the usual treatment for pneumonia prescribed by their treating doctor.
| Study group | Role | What they receive |
|---|---|---|
| Inervention group | Experimental | The intervention group will be subject to RPP. Techniques of slow expiration will be used and slow inspiration for the sweeping of secretions, during its expulsion forced expiratory techniques will be used (tracheal reflex). 10 sessions will be performed, one a day from Monday to Friday, with a duration of 10 to 15 minutes. Receives: Other: Respiratory Pediatric Physiotherapy |
| Control Group | Placebo comparator | Will be subject to PD plus muscle belly compressions of the upper limbs for 10 sessions, one session a day from Monday to Friday, with a duration de 10 to 15 minutes per patient. Both groups will receive the usual treatment for pneumonia prescribed by their treating doctor. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory difficulty
The Silverman score will be used with a range of 0 to 10 points, directly proportional between the sum and the respiratory difficulty.
Measured: 5 days
Secondary outcomes (1)
Hospital stay
Days of hospital stay
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start3 Feb 2018
- Primary completion4 Aug 2023
- Study completion4 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pneumonia ChildhoodStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The population will consist of children aged from 0 to 8 years old diagnosed with pneumonia with a development time less than 7 days. he sample calculation corresponds to 40 participants per group. The intervention group will be exposed to techniques such as prolonged slow expiration, controlled expiratory flow exercises, tracheal pumping and tracheal reflex. The control group will be subject to postural drainage plus compressions to the muscle belly of the upper limbs. Both groups will go through 10 sessions: One daily session from Monday to Friday with a duration of 10 to 15 minutes each
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil de Mexico Federico Gomez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian Morales Muñoz, Hospital Infantil de Mexico Federico Gomez
- Investigators
- Adrian Morales, Fisioterapia, Principal investigator, Hospital Infantil de Mexico Federico Gomez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174454
- Sponsor's protocol ID
- HIM2017-055 SSA1376
- Status last verified
- Dec 2023
- First submitted
- 18 Feb 2018
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Girardi G, et al. El Programa IRA en Chile: hitos e historia. Chil Ped (Chil). 2001; 72: 292-300.
European Respiratory Society Annual Congress. Effects of a new chest physiotherapy protocol in infant RSV bronchiolitis; 4-8 october. Berlín: European Respiratory Society; 2008.
Postiaux G, Hankard R, Saulnier JP, Karolewicz S, Benielli J, Le Dinahet T, Louis J. Chest physical therapy in infant acute viral bronchiolitis: should we really surrender? Arch Pediatr. 2014 May;21(5):452-3. doi: 10.1016/j.arcped.2014.02.029. Epub 2014 Apr 8. No abstract available.
PubMed 24721416
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Respiratory Pediatric Physiotherapy on a Child With Hospital Treated Pneumonia: Single-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06174454
- Acronym / sponsor ID
- HIM2017-055 SSA1376
- Conditions
- Pneumonia Childhood, Rehabilitation, Recovery of Function
- Keywords
- Pneumonia, Respiratory Pediatric Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Hospital Infantil de Mexico Federico GomezUniversity, hospital or other
- Study start
- 3 Feb 2018 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 4 Nov 2023 (actual)
- First posted
- 18 Dec 2023 (actual)
- 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 accumulation of secretions in the bronchopulmonary air network promotes the detriment of respiratory functions generating hypoxia and causing a decrease in the cardiac output requiring the use of mechanical ventilation and hemodynamic support. It is intended to control the accumulation of secretions by means of Respiratory Pediatric Physiotherapy (RPP) and to evaluate its effectiveness counting on biological plausibility.
Detailed description
The OBJECTIVE of this research protocol is to evaluate the effectiveness of RPP compared to postural drainage plus compression to the muscle belly of the upper limbs, as an adjuvant treatment for children with pneumonia. It is expected that the clinical severity decreases by 1.5 in the Wang score (a modification of the Silverman score), with a standard deviation of 2.6 points and a decrease of two days in the hospital stay with a α 0.05 in a one-tail test, a P of 80% and a 95.5% confidence interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The population will consist of children aged from 0 to 8 years old diagnosed with pneumonia with a development time less than 7 days. he sample calculation corresponds to 40 participants per group. The intervention group will be exposed to techniques such as prolonged slow expiration, controlled expiratory flow exercises, tracheal pumping and tracheal reflex. The control group will be subject to postural drainage plus compressions to the muscle belly of the upper limbs. Both groups will go through 10 sessions: One daily session from Monday to Friday with a duration of 10 to 15 minutes each
| Arm | Type | Receives |
|---|---|---|
| Inervention group | Experimental | Other: Respiratory Pediatric PhysiotherapyThe intervention group will be subject to RPP. Techniques of slow expiration will be used and slow inspiration for the sweeping of secretions, during its expulsion forced expiratory techniques will be used (tracheal reflex). 10 sessions will be performed, one a day from Monday to Friday, with a duration of 10 to 15 minutes. |
| Control Group | Placebo comparator | Other: Control GroupWill be subject to PD plus muscle belly compressions of the upper limbs for 10 sessions, one session a day from Monday to Friday, with a duration de 10 to 15 minutes per patient. Both groups will receive the usual treatment for pneumonia prescribed by their treating doctor. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients from the Hospital Infantil de México Federico Góme with diagnosis of pneumonia (considering the diagnostic criteria of the WHO and the Guidelines for Nosocomial Pneumonia from the infectiology department.
- Patients aged 0 to 8 years old.
- A minimum HS of 72 hours.
- Having informed consent.
- Not having had previous RPP treatment.
Key exclusion criteria (12 listed)
- Presenting a fever state for more than three days. Performing physiotherapy increases the body's peripheral temperature.
- Presenting an oxygen saturation below 80%.
- Requiring mechanical ventilation.
- Hemodynamic instability.
- Presenting systemic inflammatory response syndrome.
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 |
|---|---|---|
| Respiratory Pediatric PhysiotherapyAlso: Fisioterapia torácica pediatricaProlonged slow expiration Tracheal pumping Controlled expiratory flow exercises Forced expiration technique | Other | Inervention group |
| Control GroupWill be subject to muscle compressions of the upper limbs. Both groups will receive the usual treatment for pneumonia prescribed by their treating doctor. | Other | Control Group |
Primary outcome
Respiratory difficulty
Time frame: 5 days
The Silverman score will be used with a range of 0 to 10 points, directly proportional between the sum and the respiratory difficulty.
1 secondary outcome
Hospital stay
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- BackgroundGirardi G, et al. El Programa IRA en Chile: hitos e historia. Chil Ped (Chil). 2001; 72: 292-300.
- BackgroundEuropean Respiratory Society Annual Congress. Effects of a new chest physiotherapy protocol in infant RSV bronchiolitis; 4-8 october. Berlín: European Respiratory Society; 2008.
- Results publication: PubMed 24721416Postiaux G, Hankard R, Saulnier JP, Karolewicz S, Benielli J, Le Dinahet T, Louis J. Chest physical therapy in infant acute viral bronchiolitis: should we really surrender? Arch Pediatr. 2014 May;21(5):452-3. doi: 10.1016/j.arcped.2014.02.029. Epub 2014 Apr 8. No abstract available.
- Individual participant dataSharing planned: No
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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.
Adrian Morales, Fisioterapia principal investigator
Hospital Infantil de Mexico Federico Gomez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Pediatric Physiotherapy in people with Pneumonia Childhood and Rehabilitation, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. 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: finished, as of the sponsor's last update on 18 Dec 2023. 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 Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Respiratory difficulty (time frame: 5 days). 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 NCT06174454, which also lists 3 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 18 Dec 2023.