Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Effects of Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia During Hospitalization: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03538977
• Other study ID #: UEL-PPG Reabilitação
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2018
• Est. completion date: December 2019

Study information

• Verified date: October 2018
• Source: Universidade Estadual de Londrina
• Contact: Victoria Escobar, Pt
• Phone: 5543 991462230
• Email: escobar.vic[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 36 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hyperplasia

Intervention

Procedure:
• Hydrotherapy
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.
• Conventional Physiotherapy
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.

Locations

Country	Name	City	State
Brazil	University Hospital	Londrina	Paraná

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual de Londrina	Universidade Norte do Paraná

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain evaluation	Evaluated by Neonatal Infant Pain Scale, scores ranging from 0 to 7.	Change from baseline Neonatal Infant Pain Scale score at 15, 30 and 60 minutes.
Secondary	State of sleep and wakefulness	Neonatal behavioral assessed by Brazelton neonatal behavioral assessment scale, scores ranging from 1 to 6.	Change from baseline Brazelton neonatal behavioral assessment scale scores at 15, 30 and 60 minutes.
Secondary	Breathing pattern	Respiratory distress assessed by Silverman and Andersen bulletin, scores ranging from 0 to 2.	Change from baseline Silverman and Andersen bulletin scores at 15, 30 and 60 minutes.
Secondary	Muscular activity	Muscular activity of trapezius, serratus anterior and erector spinae assessed by surface electromiography (Root Mean Square [RMS] in Volts).	Change from baseline surface electromiography at 60 minutes.
Secondary	Respiratory rate	Respiratory rate (number of respiratory cycles per minute) will be assessed by a physiotherapist for one minute.	Change from baseline respiratory rate at 15, 30 and 60 minutes.
Secondary	Heart rate	Heart rate (number of heart beat per minute) will be assessed using a multi-parameter monitor.	Change from baseline heart rate at 15, 30 and 60 minutes.
Secondary	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.	Change from baseline salivary cortisol at 30 minutes.