Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia

NCT03538977 | Unknown

• 1 other identifier: UEL-PPG Reabilitação
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia

Keywords

Bronchopulmonary Dysplasia; Hydrotherapy; Electromyography; Pain; Prematurity

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline peripheral oxygen saturation at 15, 30 and 60 minutes

Secondary Outcomes (7)

• Pain evaluation

  Change from baseline Neonatal Infant Pain Scale score at 15, 30 and 60 minutes.

• State of sleep and wakefulness

  Change from baseline Brazelton neonatal behavioral assessment scale scores at 15, 30 and 60 minutes.

• Breathing pattern

  Change from baseline Silverman and Andersen bulletin scores at 15, 30 and 60 minutes.

• Muscular activity

  Change from baseline surface electromiography at 60 minutes.

• Respiratory rate

  Change from baseline respiratory rate at 15, 30 and 60 minutes.

Study Arms (2)

Conventional physiotherapy (GP)

ACTIVE COMPARATOR

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.

Procedure: Conventional Physiotherapy

GP + hydrotherapy (GH)

EXPERIMENTAL

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.

Procedure: Hydrotherapy

Interventions

Hydrotherapy PROCEDURE

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.

Also known as: Hydrotherapies, Whirlpool Bath, Whirlpool Baths, Bath, Whirpool, Baths, Whirlpool

GP + hydrotherapy (GH)

Conventional Physiotherapy PROCEDURE

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.

Conventional physiotherapy (GP)

Eligibility Criteria

• Age: 23 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Estadual de Londrina: lead
• Universidade Norte do Paraná: collaborator

Study Sites (1)

University Hospital

Londrina, Paraná, 86038-350, Brazil

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Pain; Premature Birth

Interventions

Hydrotherapy; Baths

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation; Balneology

Study Officials

• Vanessa Probst, PhD

  State University of Londrina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Escobar, Pt

CONTACT

5543 991462230; escobar.vic@gmail.com

Darllyana Soares, Pt

CONTACT

5543 998365921; darllyana@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 29, 2018
• Study Start: October 11, 2018
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

BR (1)