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Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia

Primary Purpose

Bronchopulmonary Dysplasia

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hydrotherapy
Conventional Physiotherapy
Sponsored by
Universidade Estadual de Londrina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchopulmonary Dysplasia focused on measuring Bronchopulmonary Dysplasia, Hydrotherapy, Electromyography, Pain, Prematurity

Eligibility Criteria

23 Weeks - 36 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • PTNB with gestational age less than 36 weeks with a diagnosis of BPD
  • Babies without heart disease
  • absence of central venous access, skin lesions, surgical wound, drainage and insufficiency of the adrenal gland.

Exclusion Criteria:

  • Those unable to perform hydrotherapy for three consecutive days due to severe respiratory effort evaluated by the Silverman Andersen Bulletin and hemodynamic instability.

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional physiotherapy (GP)

GP + hydrotherapy (GH)

Arm Description

The sample will be evaluated once a day in the morning until they complete at least 11 intervention sessions of conventional physiotherapy in five moments: immediately before therapy, immediately after, 15, 30 and 60 minutes after the intervention.While they are in need of intensive care and hospitalized in the NICU, infants will receive conventional physiotherapy care three times a day. After discharge to the intermediate care unit (ICU), patients will receive care only once a day. Evaluations and interventions will be carried out five days a week (Monday to Friday), according to the logistics of the unit.

The sample will be evaluated once a day in the morning until they complete at least 11 intervention sessions of hydrotherapy in five moments: immediately before therapy, immediately after, 15, 30 and 60 minutes after the intervention. While they are in need of intensive care and hospitalized in the NICU, infants allocated to GH, hydrotherapy will be performed once a day, associated with two sessions of conventional physiotherapy. After discharge to the intermediate care unit (ICU), patients will receive care only once a day, both conventional physiotherapy and hydrotherapy. Evaluations and interventions will be carried out five days a week (Monday to Friday), according to the logistics of the unit.

Outcomes

Primary Outcome Measures

Peripheral oxygen saturation
Peripheral oxygen saturation (%) will be measured using a pulse oximeter. Pulse oximetry is a method used to estimate the percentage of oxygen bound to hemoglobin in the blood and this variable will be assessed using a multi-parameter monitor.

Secondary Outcome Measures

Pain evaluation
Evaluated by Neonatal Infant Pain Scale, scores ranging from 0 to 7.
State of sleep and wakefulness
Neonatal behavioral assessed by Brazelton neonatal behavioral assessment scale, scores ranging from 1 to 6.
Breathing pattern
Respiratory distress assessed by Silverman and Andersen bulletin, scores ranging from 0 to 2.
Muscular activity
Muscular activity of trapezius, serratus anterior and erector spinae assessed by surface electromiography (Root Mean Square [RMS] in Volts).
Respiratory rate
Respiratory rate (number of respiratory cycles per minute) will be assessed by a physiotherapist for one minute.
Heart rate
Heart rate (number of heart beat per minute) will be assessed using a multi-parameter monitor.
Stress level
Salivary cortisol (salivary cortisol in µg/dL) will be collected by aspirating saliva from the oral cavity of the infant with a 1mL syringe and depositing the contents in an appropriate storage container.

Full Information

First Posted
April 10, 2018
Last Updated
October 11, 2018
Sponsor
Universidade Estadual de Londrina
Collaborators
Universidade Norte do Paraná
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1. Study Identification

Unique Protocol Identification Number
NCT03538977
Brief Title
Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia
Official Title
Effects of Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia During Hospitalization: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 11, 2018 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual de Londrina
Collaborators
Universidade Norte do Paraná

4. Oversight

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

5. Study Description

Brief Summary
Premature newborns (PTNB) often develop bronchopulmonary dysplasia (BPD) which can be related to an inability to maintain differences in tonus patterns (extensor and flexor) between the cervical muscles, upper and lower limbs. Babies who develop BPD remain in the neonatal intensive care unit (NICU) for a prolonged period of time, undergoing a large number of painful procedures. Exposure to pain in premature newborns (PTNB) is one of the most damaging factors in the extrauterine environment, also causing stress, which can also interfere with tonus pattern. Therefore, the aim of this study is to evaluate the effects of hydrotherapy on muscular activity, pain, sleep and wakefulness, stress, physiological conditions and the need for oxygen in PTNB with BPD during hospitalization in the neonatal unit. EXPECTED RESULTS: Hydrotherapy is expected to relieve pain, improve sleep quality and reduce oxygen therapy and ventilatory support in hospitalized PTNB babies with BPD.
Detailed Description
INTRODUTION:The development of medicine in recent years, especially in neonatology, has contributed to a considerable reduction in mortality rates,however, with the increase in diseases that contribute to morbidity and mortality, such as bronchopulmonary dysplasia (BPD). Such condition is defined by the need for supplemental oxygen and/or ventilatory support for more than 28 days.One of the complications of BPD is the inability to maintain differences in tonus patterns(extensor and flexor) between the cervical muscles, upper and lower limbs, which can be assessed by surface electromyography (EMG). Babies who develop BPD remain in the neonatal intensive care unit (NICU) for a prolonged period of time, undergoing a large number of painful procedures.Exposure to pain in premature newborns (PTNB) is one of the most damaging factors in the extrauterine environment, also causing stress, which can be measured by salivary cortisol.Studies with pain relief methods in these babies are needed, such as hydrotherapy.This approach has proven to be effective and safe in reducing the signs of pain and stress and to improve sleep quality in preterm infants in the NICU, besides improving physiological parameters, such as peripheral oxygen saturation. OBJECTIVES: To evaluate the effects of hydrotherapy on muscular activity, pain, sleep and wakefulness, stress, physiological conditions and the need for oxygen in PTNB with BPD during hospitalization in the neonatal unit. METHODOLOGY: PTNB with a diagnosis of BPD will be randomized into two groups: conventional physiotherapy (GP) and conventional physiotherapy plus hydrotherapy (GH). The PTNB randomized to GH will be submitted to 11 hydrotherapy sessions. The PTNB from both groups will be submitted to evaluation of heart rate (HR), peripheral oxygen saturation (SpO2), respiratory rate (RR), pain, respiratory distress, sleep state, and wakefulness. The level of salivary cortisol and muscular activity (EMG) will also be evaluated. EXPECTED RESULTS: Hydrotherapy is expected to relieve pain, improve sleep quality and reduce oxygen therapy and ventilatory support in hospitalized PTNB babies with BPD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
Keywords
Bronchopulmonary Dysplasia, Hydrotherapy, Electromyography, Pain, Prematurity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
PTNB with a diagnosis of BPD will be randomized into two groups: conventional physiotherapy (GP) and conventional physiotherapy plus hydrotherapy (GH). The PTNB randomized to GH will be submitted to 11 hydrotherapy sessions. The PTNB from both groups will be submitted to evaluation of heart rate (HR), peripheral oxygen saturation (SpO2), respiratory rate (RR), pain, respiratory distress, sleep state, and wakefulness. The level of salivary cortisol and muscular activity (EMG) will also be evaluated.
Masking
Outcomes Assessor
Masking Description
For the evaluation of pain, respiratory effort and state of sleep and wakefulness, specific scales previously validated for this population will be used: NIPS (Neonatal Infant Pain Scale) scale, Silverman Andersen respiratory severity score, and the Brazelton Neonatal Behavioral Assessment Scale, respectively. Patients will be filmed during the five moments of assessment, and two physiotherapists blinded to the groups will watch the filming and perform the evaluation using the scales previously mentioned.
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional physiotherapy (GP)
Arm Type
Active Comparator
Arm Description
The sample will be evaluated once a day in the morning until they complete at least 11 intervention sessions of conventional physiotherapy in five moments: immediately before therapy, immediately after, 15, 30 and 60 minutes after the intervention.While they are in need of intensive care and hospitalized in the NICU, infants will receive conventional physiotherapy care three times a day. After discharge to the intermediate care unit (ICU), patients will receive care only once a day. Evaluations and interventions will be carried out five days a week (Monday to Friday), according to the logistics of the unit.
Arm Title
GP + hydrotherapy (GH)
Arm Type
Experimental
Arm Description
The sample will be evaluated once a day in the morning until they complete at least 11 intervention sessions of hydrotherapy in five moments: immediately before therapy, immediately after, 15, 30 and 60 minutes after the intervention. While they are in need of intensive care and hospitalized in the NICU, infants allocated to GH, hydrotherapy will be performed once a day, associated with two sessions of conventional physiotherapy. After discharge to the intermediate care unit (ICU), patients will receive care only once a day, both conventional physiotherapy and hydrotherapy. Evaluations and interventions will be carried out five days a week (Monday to Friday), according to the logistics of the unit.
Intervention Type
Procedure
Intervention Name(s)
Hydrotherapy
Other Intervention Name(s)
Hydrotherapies, Whirlpool Bath, Whirlpool Baths, Bath, Whirpool, Baths, Whirlpool
Intervention Description
A re-sterilizable stainless steel bucket with an upper diameter of 30 cm, a depth of 32 cm, with water at a temperature between 37 and 38º Celsius will be used. The amount of water used will be sufficient to keep the baby submerged up to shoulder height. The baby will be immersed in the heated water of the bucket and will be suspended by occipital support performed by the physiotherapist, who alternates lateral-lateral and anteroposterior movements with only static suspension. The therapy will last from eight to ten minutes and will be discontinued if there is agitation, cyanosis, worsening respiratory distress or major evacuation. If the baby is using any type of ventilatory support or oxygen therapy, the same will be maintained during the procedure of hydrotherapy.
Intervention Type
Procedure
Intervention Name(s)
Conventional Physiotherapy
Intervention Description
Conventional physiotherapy consists of manipulations of Thoracoabdominal Rebalancing, a registered technique which uses simultaneous passive stretching of inspiratory muscles and stimulation of the diaphragm. The manipulation used to improve the dynamic diaphragm included the thoracic-abdominal and lower abdominal support maneuvers. Back repositioning was used to minimize posteriorization of the ribs and costal kyphosis due to thoracic distortion.
Primary Outcome Measure Information:
Title
Peripheral oxygen saturation
Description
Peripheral oxygen saturation (%) will be measured using a pulse oximeter. Pulse oximetry is a method used to estimate the percentage of oxygen bound to hemoglobin in the blood and this variable will be assessed using a multi-parameter monitor.
Time Frame
Change from baseline peripheral oxygen saturation at 15, 30 and 60 minutes
Secondary Outcome Measure Information:
Title
Pain evaluation
Description
Evaluated by Neonatal Infant Pain Scale, scores ranging from 0 to 7.
Time Frame
Change from baseline Neonatal Infant Pain Scale score at 15, 30 and 60 minutes.
Title
State of sleep and wakefulness
Description
Neonatal behavioral assessed by Brazelton neonatal behavioral assessment scale, scores ranging from 1 to 6.
Time Frame
Change from baseline Brazelton neonatal behavioral assessment scale scores at 15, 30 and 60 minutes.
Title
Breathing pattern
Description
Respiratory distress assessed by Silverman and Andersen bulletin, scores ranging from 0 to 2.
Time Frame
Change from baseline Silverman and Andersen bulletin scores at 15, 30 and 60 minutes.
Title
Muscular activity
Description
Muscular activity of trapezius, serratus anterior and erector spinae assessed by surface electromiography (Root Mean Square [RMS] in Volts).
Time Frame
Change from baseline surface electromiography at 60 minutes.
Title
Respiratory rate
Description
Respiratory rate (number of respiratory cycles per minute) will be assessed by a physiotherapist for one minute.
Time Frame
Change from baseline respiratory rate at 15, 30 and 60 minutes.
Title
Heart rate
Description
Heart rate (number of heart beat per minute) will be assessed using a multi-parameter monitor.
Time Frame
Change from baseline heart rate at 15, 30 and 60 minutes.
Title
Stress level
Description
Salivary cortisol (salivary cortisol in µg/dL) will be collected by aspirating saliva from the oral cavity of the infant with a 1mL syringe and depositing the contents in an appropriate storage container.
Time Frame
Change from baseline salivary cortisol at 30 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PTNB with gestational age less than 36 weeks with a diagnosis of BPD Babies without heart disease absence of central venous access, skin lesions, surgical wound, drainage and insufficiency of the adrenal gland. Exclusion Criteria: Those unable to perform hydrotherapy for three consecutive days due to severe respiratory effort evaluated by the Silverman Andersen Bulletin and hemodynamic instability.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Escobar, Pt
Phone
5543 991462230
Email
escobar.vic@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Darllyana Soares, Pt
Phone
5543 998365921
Email
darllyana@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Probst, PhD
Organizational Affiliation
State University of Londrina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Londrina
State/Province
Paraná
ZIP/Postal Code
86038-350
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa S Probst, PT, PhD
Phone
+554333712490
Email
vanessaprobst@gmail.com
First Name & Middle Initial & Last Name & Degree
Darllyana S Soares, PT
Phone
+554333712490
Email
darllyana@hotmail.com
First Name & Middle Initial & Last Name & Degree
Vanessa S Probst, PT, PhD

12. IPD Sharing Statement

Learn more about this trial

Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia

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