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Repercussions of Respiratory Physiotherapy in Preterm Infants Under Mechanical Ventilation (preterm)

Primary Purpose

Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional Physiotherapy
Prolonged slow exhalation technique
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Birth

Eligibility Criteria

30 Weeks - 34 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Preterms born at gestational age <35 weeks under mechanical ventilation

Exclusion Criteria:

  • congenital malformation graves;
  • genetic syndromes,
  • pulmonary hypertension,
  • peri-intraventricular haemorrhage and coagulopathies.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Conventional Physiotherapy (PT)

    Prolonged slow exhalation technique

    Arm Description

    Postural drainage + manual vibration

    Prolonged exhalation + Conventional PT

    Outcomes

    Primary Outcome Measures

    Tidal volume
    Measured by the mechanical ventilator

    Secondary Outcome Measures

    Respiratory rate
    Measured by the mechanical ventilator

    Full Information

    First Posted
    April 6, 2017
    Last Updated
    March 13, 2018
    Sponsor
    Universidade Cidade de Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03159039
    Brief Title
    Repercussions of Respiratory Physiotherapy in Preterm Infants Under Mechanical Ventilation
    Acronym
    preterm
    Official Title
    Study of Clinical Repercussions of Conventional Respiratory Physiotherapy Versus Prolonged Slow Expiration in Preterms Under Mechanical Ventilation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    October 2016 (Actual)
    Study Completion Date
    October 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Cidade de Sao Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Birth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Participant
    Allocation
    Randomized
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional Physiotherapy (PT)
    Arm Type
    Experimental
    Arm Description
    Postural drainage + manual vibration
    Arm Title
    Prolonged slow exhalation technique
    Arm Type
    Active Comparator
    Arm Description
    Prolonged exhalation + Conventional PT
    Intervention Type
    Other
    Intervention Name(s)
    Conventional Physiotherapy
    Other Intervention Name(s)
    Postural drainage
    Intervention Type
    Other
    Intervention Name(s)
    Prolonged slow exhalation technique
    Intervention Description
    Postural drainage associated with manual vibration and a mild pressure in the end of expiratory phase
    Primary Outcome Measure Information:
    Title
    Tidal volume
    Description
    Measured by the mechanical ventilator
    Time Frame
    10 minutes twice a day
    Secondary Outcome Measure Information:
    Title
    Respiratory rate
    Description
    Measured by the mechanical ventilator
    Time Frame
    10 minutes twice a day
    Other Pre-specified Outcome Measures:
    Title
    Peripheral oxygen saturation
    Description
    Measured by the oxymeter
    Time Frame
    10 minutes twice a day
    Title
    Heart rate
    Description
    Measured by the oxymeter
    Time Frame
    10 minutes twice a day

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    gestational age (GA) <35 weeks
    Minimum Age & Unit of Time
    30 Weeks
    Maximum Age & Unit of Time
    34 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • Preterms born at gestational age <35 weeks under mechanical ventilation Exclusion Criteria: congenital malformation graves; genetic syndromes, pulmonary hypertension, peri-intraventricular haemorrhage and coagulopathies.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Beatriz Sraiva-Romanholo, PhD
    Organizational Affiliation
    Universidade Cidade de Sao Paulo
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    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.
    Results Reference
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    Repercussions of Respiratory Physiotherapy in Preterm Infants Under Mechanical Ventilation

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