Repercussions of Respiratory Physiotherapy in Preterm Infants Under Mechanical Ventilation

NCT03159039 | Completed

• 1 other identifier: preterm physiotherapy
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Tidal volume

  Measured by the mechanical ventilator

  10 minutes twice a day

Secondary Outcomes (1)

• Respiratory rate

  10 minutes twice a day

Other Outcomes (2)

• Peripheral oxygen saturation

  10 minutes twice a day

• Heart rate

  10 minutes twice a day

Study Arms (2)

Conventional Physiotherapy (PT)

EXPERIMENTAL

Postural drainage + manual vibration

Other: Conventional Physiotherapy

Prolonged slow exhalation technique

ACTIVE COMPARATOR

Prolonged exhalation + Conventional PT

Other: Prolonged slow exhalation technique

Interventions

Conventional Physiotherapy OTHER

Also known as: Postural drainage

Conventional Physiotherapy (PT)

Prolonged slow exhalation technique OTHER

Postural drainage associated with manual vibration and a mild pressure in the end of expiratory phase

Prolonged slow exhalation technique

Eligibility Criteria

• Age: 30 Weeks - 34 Weeks
• Gender Eligibility Details: gestational age (GA) \<35 weeks
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

Drainage, Postural

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Physical Therapy Modalities; Rehabilitation; Respiratory Therapy

Study Officials

• Beatriz Sraiva-Romanholo, PhD

  Universidade Cidade de Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: May 18, 2017
• Study Start: January 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2017
• Last Updated: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share