PrematureEarly Phase 1RPCPPWPNCT03027206
Respiratory Physiotherapy Change Premature Pain With Pneumonia
A Early Phase 1 study testing Vibration technique and Acceleration of expiratory flow in people with Premature and Pneumonia, run by Amazon University.
Trial summary
Objective to evaluate the effects of vibration techniques and acceleration of expiratory flow on pain parameters in preterm infants diagnosed with pneumonia hospitalized in the Intensive Care Unit and Neonatal Intermediate Care Unit. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- What is being tested?
- Vibration technique and Acceleration of expiratory flow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Nov 2016
- Phase
- Early Phase 1
- 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 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Included in this study were RNPT of both genders, of low weight (1500 to 2500g) or normal weight (over 2500g).
- With clinical diagnosis of pneumonia.
- Who were on spontaneous ventilation (ambient air or with the aid of oxygen therapy).
- Agreed to participate in the research, through the signing of the Informed Consent Form for minors.
Who cannot join
- Newborns with a gestational age greater than 37 weeks.
- With diseases or procedures that cause pain in the newborn such as necrotizing enterocolitis, thoracotraumatis, thoracic or abdominal drainage, and umbilical catheter.
- Who were less than 72 hours Life with birth weight less than 1500g (very low weight and extreme low weight).
- As well as those who underwent invasive or non-invasive mechanical ventilation.
- Sedated.
- With vasoactive drugs or medications that interfered in the physiological parameters of pain.
About this study
Official title: Effects of Vibration Techniques and Expiratory Flow Acceleration in Premature Pain Parameters With Pneumonia
Objective to evaluate the effects of vibration techniques and acceleration of expiratory flow on pain parameters in preterm infants diagnosed with pneumonia hospitalized in the Intensive Care Unit and Neonatal Intermediate Care Unit. The Method is a descriptive and interventional study, in which 28 PTNB were randomly divided into two groups: Group 1 submitted to the vibration technique and Group 2 - to the acceleration of the expiratory flow, both techniques were applied in an interval of up to ten minutes, for Three consecutive days. The pain indicators were evaluated according to the PIPP scale in three moments. For statistical analysis, the Friedman tests and Variance Analysis were applied, the level of significance adopted was 5%.
Read the detailed description
A descriptive, longitudinal, quantitative approach was carried out in which 28 preterm infants with diagnosis of pneumonia hospitalized in the NICU and NICU of the Santa Casa de Misericórdia Foundation of Pará (FSCMPA) participated in the study period from July to October 2016. The research obeyed ethical principles Of Resolution 466/12 of the National Health Council (CNS) and was initiated after approval by the Research Ethics Committee of the FSCMPA, opinion 1,690,842. The selection criteria were obtained through the collection of data from the records of newborns and annotated in standardized charts. Once included in the study, the patients were randomly divided into two groups of 14 PTNB, the premature group 1 were submitted to the vibration technique (rhythmic and rapid movements of isometric contraction of the forearm, applied manually over the anterior chest region) and the Of Group 2 to the acceleration of the expiratory flow (soft compression of the thorax applied with one hand in the lower ribs and the other using the ulnar border on the supramammary line). Both techniques were performed with the premature dorsal position, at the time of the expiratory phase, with a maximum duration of 10 minutes, once a day, for three consecutive days, in the afternoon period and by the same physiotherapist. After this procedure, aspiration of the upper airways of premature infants was performed. The pain indicators of the preterm infants (PIPP) of the two groups were evaluated in three moments, before the application of the technique (T1), immediately after the application of the technique (T2) and 15 minutes After its completion (T3), by a researcher previously trained and blind regarding the procedure performed. PIPP is a multidimensional instrument that evaluates pain indicators in the newborn using the following parameters: gestational age and alertness (contextual factors), heart rate and peripheral oxygen saturation (physiological indicators) that were measured by means of a pulse oximeter Of the brand (Dixtal®) and three aspects of facial mimetics (behavioral factors). Their scores may range from 0 to 21, scores less than or equal to 6 indicate absence of pain, scores above 6 represent mild pain and scores higher than 12 indicate the presence of moderate to severe pain.
- Conditions
- Premature, Pneumonia, Pain, Physiotherapy
- Being tested
- Vibration technique, Acceleration of expiratory flow
- Medical subject headings
- Premature Birth, Pneumonia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration techniqueOther
Comparison of different technique
Acceleration of expiratory flowOther
Comparison of different technique
| Study group | Role | What they receive |
|---|---|---|
| Vibration technique | Experimental | Rhythmic and rapid movements of isometric contraction of the forearm, applied manually over the anterior region of the thorax Receives: Other: Vibration technique |
| Acceleration of expiratory flow | Experimental | Soft compression of the thorax applied with one hand on the lower ribs and the other using the ulnar border on the supramammary line Receives: Other: Acceleration of expiratory flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the parameters of the pain profile scale in preterm infants at different times
The pain indicators of the preterm infants (PIPP) of the two groups were evaluated in three moments, before the application of the technique (T1), immediately after the application of the technique (T2) and 15 minutes After its termination (T3), by a researcher previously trained and blind as to the procedure performed
Measured: The total collection period was six months, and each procedure was performed on the volunteers for three consecutive days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startJun 2015
- Primary completionJul 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PrematureStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazon University
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação Santa Casa de Misericórdia do Pará (FSCMPA)
- Responsible party
- Principal investigator, Paulo Eduardo Santos Avila, Amazon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027206
- Sponsor's protocol ID
- 1.690.842
- Acronym
- RPCPPWP
- Status last verified
- Jan 2017
- First submitted
- 21 Nov 2016
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Patel RM, Kandefer S, Walsh MC, Bell EF, Carlo WA, Laptook AR, Sanchez PJ, Shankaran S, Van Meurs KP, Ball MB, Hale EC, Newman NS, Das A, Higgins RD, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Causes and timing of death in extremely premature infants from 2000 through 2011. N Engl J Med. 2015 Jan 22;372(4):331-40. doi: 10.1056/NEJMoa1403489.
PubMed 25607427Walker CLF, Rudan I, Liu L, Nair H, Theodoratou E, Bhutta ZA, O'Brien KL, Campbell H, Black RE. Global burden of childhood pneumonia and diarrhoea. Lancet. 2013 Apr 20;381(9875):1405-1416. doi: 10.1016/S0140-6736(13)60222-6. Epub 2013 Apr 12.
PubMed 23582727Brandao AM, Domingues AP, Fonseca EM, Miranda TM, Belo A, Moura JP. [Premature labour with or without preterm premature rupture of membranes: maternal, obstetric and neonatal features]. Rev Bras Ginecol Obstet. 2015 Sep;37(9):428-33. doi: 10.1590/SO100-720320150005283. Portuguese.
PubMed 26352946Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2016 Jul 16;7(7):CD001069. doi: 10.1002/14651858.CD001069.pub5.
PubMed 27420164Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57. doi: 10.1542/peds.113.4.846.
PubMed 15060237Silva YP, Gomez RS, Maximo TA, Silva AC. [Pain evaluation in neonatology.]. Rev Bras Anestesiol. 2007 Oct;57(5):565-74. Portuguese.
PubMed 19462133
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vibration Techniques and Expiratory Flow Acceleration in Premature Pain Parameters With Pneumonia
- ClinicalTrials.gov ID
- NCT03027206
- Acronym / sponsor ID
- RPCPPWP / 1.690.842
- Conditions
- Premature, Pneumonia, Pain, Physiotherapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Amazon UniversityUniversity, hospital or other
- Collaborators
- Fundação Santa Casa de Misericórdia do Pará (FSCMPA)
- Study start
- Jun 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 23 Jan 2017 (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.
Objective to evaluate the effects of vibration techniques and acceleration of expiratory flow on pain parameters in preterm infants diagnosed with pneumonia hospitalized in the Intensive Care Unit and Neonatal Intermediate Care Unit. The Method is a descriptive and interventional study, in which 28 PTNB were randomly divided into two groups: Group 1 submitted to the vibration technique and Group 2 - to the acceleration of the expiratory flow, both techniques were applied in an interval of up to ten minutes, for Three consecutive days. The pain indicators were evaluated according to the PIPP scale in three moments. For statistical analysis, the Friedman tests and Variance Analysis were applied, the level of significance adopted was 5%.
Detailed description
A descriptive, longitudinal, quantitative approach was carried out in which 28 preterm infants with diagnosis of pneumonia hospitalized in the NICU and NICU of the Santa Casa de Misericórdia Foundation of Pará (FSCMPA) participated in the study period from July to October 2016. The research obeyed ethical principles Of Resolution 466/12 of the National Health Council (CNS) and was initiated after approval by the Research Ethics Committee of the FSCMPA, opinion 1,690,842. The selection criteria were obtained through the collection of data from the records of newborns and annotated in standardized charts. Once included in the study, the patients were randomly divided into two groups of 14 PTNB, the premature group 1 were submitted to the vibration technique (rhythmic and rapid movements of isometric contraction of the forearm, applied manually over the anterior chest region) and the Of Group 2 to the acceleration of the expiratory flow (soft compression of the thorax applied with one hand in the lower ribs and the other using the ulnar border on the supramammary line). Both techniques were performed with the premature dorsal position, at the time of the expiratory phase, with a maximum duration of 10 minutes, once a day, for three consecutive days, in the afternoon period and by the same physiotherapist. After this procedure, aspiration of the upper airways of premature infants was performed. The pain indicators of the preterm infants (PIPP) of the two groups were evaluated in three moments, before the application of the technique (T1), immediately after the application of the technique (T2) and 15 minutes After its completion (T3), by a researcher previously trained and blind regarding the procedure performed. PIPP is a multidimensional instrument that evaluates pain indicators in the newborn using the following parameters: gestational age and alertness (contextual factors), heart rate and peripheral oxygen saturation (physiological indicators) that were measured by means of a pulse oximeter Of the brand (Dixtal®) and three aspects of facial mimetics (behavioral factors). Their scores may range from 0 to 21, scores less than or equal to 6 indicate absence of pain, scores above 6 represent mild pain and scores higher than 12 indicate the presence of moderate to severe pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration technique | Experimental | Other: Vibration techniqueRhythmic and rapid movements of isometric contraction of the forearm, applied manually over the anterior region of the thorax |
| Acceleration of expiratory flow | Experimental | Other: Acceleration of expiratory flowSoft compression of the thorax applied with one hand on the lower ribs and the other using the ulnar border on the supramammary line |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Included in this study were RNPT of both genders, of low weight (1500 to 2500g) or normal weight (over 2500g).
- With clinical diagnosis of pneumonia.
- Who were on spontaneous ventilation (ambient air or with the aid of oxygen therapy).
- Agreed to participate in the research, through the signing of the Informed Consent Form for minors.
Key exclusion criteria (6 listed)
- Newborns with a gestational age greater than 37 weeks.
- With diseases or procedures that cause pain in the newborn such as necrotizing enterocolitis, thoracotraumatis, thoracic or abdominal drainage, and umbilical catheter.
- Who were less than 72 hours Life with birth weight less than 1500g (very low weight and extreme low weight).
- As well as those who underwent invasive or non-invasive mechanical ventilation.
- Sedated.
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 |
|---|---|---|
| Vibration techniqueComparison of different technique | Other | Vibration technique |
| Acceleration of expiratory flowComparison of different technique | Other | Acceleration of expiratory flow |
Primary outcome
Evaluation of the parameters of the pain profile scale in preterm infants at different times
Time frame: The total collection period was six months, and each procedure was performed on the volunteers for three consecutive days.
The pain indicators of the preterm infants (PIPP) of the two groups were evaluated in three moments, before the application of the technique (T1), immediately after the application of the technique (T2) and 15 minutes After its termination (T3), by a researcher previously trained and blind as to the procedure performed
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 23 Jan 2017.
- Results publication: PubMed 25607427Patel RM, Kandefer S, Walsh MC, Bell EF, Carlo WA, Laptook AR, Sanchez PJ, Shankaran S, Van Meurs KP, Ball MB, Hale EC, Newman NS, Das A, Higgins RD, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Causes and timing of death in extremely premature infants from 2000 through 2011. N Engl J Med. 2015 Jan 22;372(4):331-40. doi: 10.1056/NEJMoa1403489.
- Results publication: PubMed 23582727Walker CLF, Rudan I, Liu L, Nair H, Theodoratou E, Bhutta ZA, O'Brien KL, Campbell H, Black RE. Global burden of childhood pneumonia and diarrhoea. Lancet. 2013 Apr 20;381(9875):1405-1416. doi: 10.1016/S0140-6736(13)60222-6. Epub 2013 Apr 12.
- Results publication: PubMed 26352946Brandao AM, Domingues AP, Fonseca EM, Miranda TM, Belo A, Moura JP. [Premature labour with or without preterm premature rupture of membranes: maternal, obstetric and neonatal features]. Rev Bras Ginecol Obstet. 2015 Sep;37(9):428-33. doi: 10.1590/SO100-720320150005283. Portuguese.
- Results publication: PubMed 27420164Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2016 Jul 16;7(7):CD001069. doi: 10.1002/14651858.CD001069.pub5.
- Results publication: PubMed 15060237Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57. doi: 10.1542/peds.113.4.846.
- Results publication: PubMed 19462133Silva YP, Gomez RS, Maximo TA, Silva AC. [Pain evaluation in neonatology.]. Rev Bras Anestesiol. 2007 Oct;57(5):565-74. Portuguese.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vibration technique and Acceleration of expiratory flow in people with Premature and Pneumonia, run by Amazon University.
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 4 inclusion and 6 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 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluation of the parameters of the pain profile scale in preterm infants at different times (time frame: The total collection period was six months, and each procedure was performed on the volunteers for three consecutive 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 NCT03027206, which also lists 6 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 23 Jan 2017.