Respiratory Physiotherapy Change Premature Pain With Pneumonia

NCT03027206 | Completed Early Phase 1 DMC

• 1 other identifier: 1.690.842
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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. 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%.

Conditions

Premature; Pneumonia; Pain; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

  The total collection period was six months, and each procedure was performed on the volunteers for three consecutive days.

Study Arms (2)

Vibration technique

EXPERIMENTAL

Rhythmic and rapid movements of isometric contraction of the forearm, applied manually over the anterior region of the thorax

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

Other: Acceleration of expiratory flow

Interventions

Vibration technique OTHER

Comparison of different technique

Vibration technique

Acceleration of expiratory flow OTHER

Comparison of different technique

Acceleration of expiratory flow

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amazon University: lead
• Fundação Santa Casa de Misericórdia do Pará (FSCMPA): collaborator

Related Publications (6)

• 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.

  PMID: 25607427 RESULT

• Walker 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.

  PMID: 23582727 RESULT

• Brandao 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.

  PMID: 26352946 RESULT

• Stevens 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.

  PMID: 27420164 RESULT

• Als 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.

  PMID: 15060237 RESULT

• Silva YP, Gomez RS, Maximo TA, Silva AC. [Pain evaluation in neonatology.]. Rev Bras Anestesiol. 2007 Oct;57(5):565-74. Portuguese.

  PMID: 19462133 RESULT

MeSH Terms

Conditions

Premature Birth; Pneumonia; Pain

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant teacher

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: January 23, 2017
• Study Start: June 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 23, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share