Preterm BirthpretermNCT03159039
Repercussions of Respiratory Physiotherapy in Preterm Infants Under Mechanical Ventilation
A study testing Conventional Physiotherapy and Prolonged slow exhalation technique in people with Preterm Birth, run by Universidade Cidade de Sao Paulo.
Trial summary
Respiratory diseases are a major morbidity and mortality causes of neonatal requiring mechanical ventilation, especially in newborn preterm infants (PN), thus respiratory therapy becomes increasingly necessary in order to minimize the effects of complications and improve respiratory functions, increasing mucociliary… Read more about this study
- Who is it for?
- Ages 30 to 34 weeks
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Conventional Physiotherapy and Prolonged slow exhalation technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Oct 2017
- 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 30 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterms born at gestational age <35 weeks under mechanical ventilation
Who cannot join
- congenital malformation graves;
- genetic syndromes,
- pulmonary hypertension,
- peri-intraventricular haemorrhage and coagulopathies.
About this study
Official title: Study of Clinical Repercussions of Conventional Respiratory Physiotherapy Versus Prolonged Slow Expiration in Preterms Under Mechanical Ventilation
Respiratory diseases are a major morbidity and mortality causes of neonatal requiring mechanical ventilation, especially in newborn preterm infants (PN), thus respiratory therapy becomes increasingly necessary in order to minimize the effects of complications and improve respiratory functions, increasing mucociliary transport with techniques that consist of manual maneuvers to bronchial hygiene, such as vibro associated with postural drainage and prolonged slow exhalation. Objective: To compare and analyze the effects of convensional physiotherapy (CP) versus prolonged slow exhalation (PSE) in heart rate (HR), and respiratory rate (RR), O2 saturation (SpO2) and Tidal Volume (TV), time permanence of mechanical ventilation (TMV) and number of extubation failure (EF) in premature infants on mechanical ventilation (MV). Methods: Randomized clinical trial conducted in the neonatal intensive care unit of the General Hospital Itapecerica da Serra Seconci OSS SP, comparing two physical therapy techniques applied to preterm infants on mechanical ventilation.
Read the detailed description
Neonates patients admitted at unit of Intensive Care of Geral Hospital of Itapecerica da Serra (São Paulo-Brazil) will recruited to this study. Based on World Health Organization (WHO), the neonates preterm are those who present gestational age (GA) <35 weeks (gestational age was calculated based on the date of last menstruation). Inclusion criteria: neonates born at GA<35 weeks, under mechanical ventilation (interplus 5 -Intermédica® or servo i (Maquet, Solvan, Sweden) for the first 7 days of life, hemodynamically stable; birth weight ≤1.500 gram; per cent change inspired oxygen received (FiO2) ≤ 0.6; Inspiratory pressure ≥ 25 cmH2O; medical prescription of chest physiotherapy. Exclusion criteria: congenital malformation graves; genetic syndromes and situations, pulmonary hypertension, peri-intraventricular hemorrhage and coagulopathies.
All patients will receive chest physiotherapy when it is necessary and all of them will monitored until dischange.
After performed all included criteria, patients will randomized in 2 groups: group CCP (patients submitted to conventional chest physiotherapy techniques) or group PSE (patients submitted to prolonged slow exhalation technique).
After that, for both group, physiotherapist take note of gestacional age, gender, bith weight (gram), Apgar score (1º; 5º and 10º minute), type of delivery, medical diagnosis, mechanical ventilation parameters, medications. Then, lung auscultation, breathing pattern, pulse oximetry and radiological chest pattern of all patients will evaluated by the same physiotherapist.
CCP group (n=22): patients will submitted to a postural drainage associated with manual vibration. They will positionated with left or right of ribcage to up and then physiotherapist made a manual vibratory movements associated with a mild compression in ribcage at the end of expiratory phase. The technique was made during 5 minutes in each side. After that, endotraqueal aspiration will performed.
PSE group (n=21): patients will carefully positionated with head up (30º) and then physiotherapist put one hand around ribcage area e another in abdominal area then he made a mild pressure in both areas at the same time in the end of expiratory phase of patient until residual volume keeping the pressure for 2 seconds. This technique will made during 10 minutes.At the end, endotraqueal aspiration will perfomed.
Both techniques will realized with the same physiotherapist, 2 times a day (morning and afternoon) during 10 minutes and all data were recorded during the 2 first days of physiotherapy assistance.
During the protocol, the follow data will recorded: respiratory rate (digital timer C4539-Brady, Brazil), heart rate and peripheral oxygen saturation (multiparameter monitor DX 2010 -Dixtal Biomédica, Brazil), exhaled tidal volume (internal sensor ventilation mechanical), number of days under mechanical ventilation and number of fail times in extubation. These parameters will recorded in 5 diferent moments: T0 (before beginning of physiotherapy);T1 (immediately after physiotherapy technique); T2 (immediately after cannula aspiration); T3 (after 5 minutes of all procedures); T4 (20 minutes after all procedures).
- Conditions
- Preterm Birth
- Being tested
- Conventional Physiotherapy, Prolonged slow exhalation technique
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PhysiotherapyOther
Also called Postural drainage
Prolonged slow exhalation techniqueOther
Postural drainage associated with manual vibration and a mild pressure in the end of expiratory phase
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physiotherapy (PT) | Experimental | Postural drainage + manual vibration Receives: Other: Conventional Physiotherapy |
| Prolonged slow exhalation technique | Active comparator | Prolonged exhalation + Conventional PT Receives: Other: Prolonged slow exhalation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume
Measured by the mechanical ventilator
Measured: 10 minutes twice a day
Secondary outcomes (1)
Respiratory rate
Measured by the mechanical ventilator
Measured: 10 minutes twice a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study startJan 2015
- Primary completionOct 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies 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
- Patients will randomized in 2 groups: group CCP (conventional chest physiotherapy techniques) (n=22) , the technique will made during 5 minutes in each side and after that, endotraqueal aspiration will performed.or group PSE (prolonged slow exhalation technique) (n=21), the technique will made during 10 minutes, 2 times a day.At the end, endotraqueal aspiration will perfomed. During the protocol the parameters will recorder: respiratory rate, heart rate and peripheral oxygen saturation, exhaled tidal volume, number of days under mechanical ventilation and number of fail times in extubation. In 5 diferent moments.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viviani Barnabe, Universidade Cidade de Sao Paulo
- Investigators
- Beatriz Sraiva-Romanholo, PhD, Study chair, Universidade Cidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159039
- Sponsor's protocol ID
- preterm physiotherapy
- Acronym
- preterm
- Status last verified
- Mar 2018
- First submitted
- 6 Apr 2017
- Last updated
- 15 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blencowe H, Cousens S, Chou D, et al. Born Too Soon: The global epidemiology of 15 million preterm births. Reproductive Health. 2013;10(Suppl 1):S2. doi:10.1186/1742-4755-10-S1-S2. Beck , Wojdyla LS, Betran AP, Merialdi M, Requejo JH, Rubens C, et al. The worldwide incidence of preterm birth: a systematic review of maternal mortality and morbidity. Bull World Health Organ. 2010; 88:31-8. Koivisto M, Marttila R, Kurkinen-Raty M, Saarela T, Pokela ML, Jouppila P, et al. Changing incidence and outcome of infants with respiratory distress syndrome in the 1990s: a population-based survey. Acta Paediatr. 2004; 93: 177-184. Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet .2008;371:75-84. Kamath BD, MacGuire ER, McClure EM, Goldenberg RL, Jobe AH. Neonatal Mortality From Respiratory Distress Syndrome: Lessons for Low-Resource Countries. Pediatrics.2011;127:1139-1146. doi: 9.1542/peds.2010-3212 10. Sweet, David G., et al.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Clinical Repercussions of Conventional Respiratory Physiotherapy Versus Prolonged Slow Expiration in Preterms Under Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03159039
- Acronym / sponsor ID
- preterm / preterm physiotherapy
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 18 May 2017 (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.
Respiratory diseases are a major morbidity and mortality causes of neonatal requiring mechanical ventilation, especially in newborn preterm infants (PN), thus respiratory therapy becomes increasingly necessary in order to minimize the effects of complications and improve respiratory functions, increasing mucociliary transport with techniques that consist of manual maneuvers to bronchial hygiene, such as vibro associated with postural drainage and prolonged slow exhalation. Objective: To compare and analyze the effects of convensional physiotherapy (CP) versus prolonged slow exhalation (PSE) in heart rate (HR), and respiratory rate (RR), O2 saturation (SpO2) and Tidal Volume (TV), time permanence of mechanical ventilation (TMV) and number of extubation failure (EF) in premature infants on mechanical ventilation (MV). Methods: Randomized clinical trial conducted in the neonatal intensive care unit of the General Hospital Itapecerica da Serra Seconci OSS SP, comparing two physical therapy techniques applied to preterm infants on mechanical ventilation.
Detailed description
Neonates patients admitted at unit of Intensive Care of Geral Hospital of Itapecerica da Serra (São Paulo-Brazil) will recruited to this study. Based on World Health Organization (WHO), the neonates preterm are those who present gestational age (GA) <35 weeks (gestational age was calculated based on the date of last menstruation). Inclusion criteria: neonates born at GA<35 weeks, under mechanical ventilation (interplus 5 -Intermédica® or servo i (Maquet, Solvan, Sweden) for the first 7 days of life, hemodynamically stable; birth weight ≤1.500 gram; per cent change inspired oxygen received (FiO2) ≤ 0.6; Inspiratory pressure ≥ 25 cmH2O; medical prescription of chest physiotherapy. Exclusion criteria: congenital malformation graves; genetic syndromes and situations, pulmonary hypertension, peri-intraventricular hemorrhage and coagulopathies.
All patients will receive chest physiotherapy when it is necessary and all of them will monitored until dischange.
After performed all included criteria, patients will randomized in 2 groups: group CCP (patients submitted to conventional chest physiotherapy techniques) or group PSE (patients submitted to prolonged slow exhalation technique).
After that, for both group, physiotherapist take note of gestacional age, gender, bith weight (gram), Apgar score (1º; 5º and 10º minute), type of delivery, medical diagnosis, mechanical ventilation parameters, medications. Then, lung auscultation, breathing pattern, pulse oximetry and radiological chest pattern of all patients will evaluated by the same physiotherapist.
CCP group (n=22): patients will submitted to a postural drainage associated with manual vibration. They will positionated with left or right of ribcage to up and then physiotherapist made a manual vibratory movements associated with a mild compression in ribcage at the end of expiratory phase. The technique was made during 5 minutes in each side. After that, endotraqueal aspiration will performed.
PSE group (n=21): patients will carefully positionated with head up (30º) and then physiotherapist put one hand around ribcage area e another in abdominal area then he made a mild pressure in both areas at the same time in the end of expiratory phase of patient until residual volume keeping the pressure for 2 seconds. This technique will made during 10 minutes.At the end, endotraqueal aspiration will perfomed.
Both techniques will realized with the same physiotherapist, 2 times a day (morning and afternoon) during 10 minutes and all data were recorded during the 2 first days of physiotherapy assistance.
During the protocol, the follow data will recorded: respiratory rate (digital timer C4539-Brady, Brazil), heart rate and peripheral oxygen saturation (multiparameter monitor DX 2010 -Dixtal Biomédica, Brazil), exhaled tidal volume (internal sensor ventilation mechanical), number of days under mechanical ventilation and number of fail times in extubation. These parameters will recorded in 5 diferent moments: T0 (before beginning of physiotherapy);T1 (immediately after physiotherapy technique); T2 (immediately after cannula aspiration); T3 (after 5 minutes of all procedures); T4 (20 minutes after all procedures).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will randomized in 2 groups: group CCP (conventional chest physiotherapy techniques) (n=22) , the technique will made during 5 minutes in each side and after that, endotraqueal aspiration will performed.or group PSE (prolonged slow exhalation technique) (n=21), the technique will made during 10 minutes, 2 times a day.At the end, endotraqueal aspiration will perfomed. During the protocol the parameters will recorder: respiratory rate, heart rate and peripheral oxygen saturation, exhaled tidal volume, number of days under mechanical ventilation and number of fail times in extubation. In 5 diferent moments.
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy (PT) | Experimental | Other: Conventional PhysiotherapyPostural drainage + manual vibration |
| Prolonged slow exhalation technique | Active comparator | Other: Prolonged slow exhalation techniqueProlonged exhalation + Conventional PT |
Who may qualify
- Ages
- 30 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterms born at gestational age <35 weeks under mechanical ventilation
Key exclusion criteria (4 listed)
- congenital malformation graves;
- genetic syndromes,
- pulmonary hypertension,
- peri-intraventricular haemorrhage and coagulopathies.
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 |
|---|---|---|
| Conventional PhysiotherapyAlso: Postural drainage | Other | Conventional Physiotherapy (PT) |
| Prolonged slow exhalation techniquePostural drainage associated with manual vibration and a mild pressure in the end of expiratory phase | Other | Prolonged slow exhalation technique |
Primary outcome
Tidal volume
Time frame: 10 minutes twice a day
Measured by the mechanical ventilator
1 secondary outcome
Respiratory rate
Time frame: 10 minutes twice a day
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 15 Mar 2018.
- Results publicationBlencowe H, Cousens S, Chou D, et al. Born Too Soon: The global epidemiology of 15 million preterm births. Reproductive Health. 2013;10(Suppl 1):S2. doi:10.1186/1742-4755-10-S1-S2. Beck , Wojdyla LS, Betran AP, Merialdi M, Requejo JH, Rubens C, et al. The worldwide incidence of preterm birth: a systematic review of maternal mortality and morbidity. Bull World Health Organ. 2010; 88:31-8. Koivisto M, Marttila R, Kurkinen-Raty M, Saarela T, Pokela ML, Jouppila P, et al. Changing incidence and outcome of infants with respiratory distress syndrome in the 1990s: a population-based survey. Acta Paediatr. 2004; 93: 177-184. Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet .2008;371:75-84. Kamath BD, MacGuire ER, McClure EM, Goldenberg RL, Jobe AH. Neonatal Mortality From Respiratory Distress Syndrome: Lessons for Low-Resource Countries. Pediatrics.2011;127:1139-1146. doi: 9.1542/peds.2010-3212 10. Sweet, David G., et al.
- Individual participant dataSharing planned: No
Related trials for Preterm Birth
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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.
Beatriz Sraiva-Romanholo, PhD study chair
Universidade Cidade de Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physiotherapy and Prolonged slow exhalation technique in people with Preterm Birth, run by Universidade Cidade de Sao Paulo.
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 1 inclusion and 4 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 15 Mar 2018. 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.
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?
Tidal volume (time frame: 10 minutes twice a day). 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 NCT03159039, which also lists 1 linked publication.
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 15 Mar 2018.