Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia

Not Applicable

• Conditions: Bronchopulmonary Dysplasia

• Registration Number: NCT03538977
• Lead Sponsor: Universidade Estadual de Londrina

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.

Study Timeline

• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-05-29
• Status Verified: 2018-10
• Study Start: 2018-10-11
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-16
• Primary Completion: 2019-05
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Peripheral oxygen saturation	Change from baseline peripheral oxygen saturation at 15, 30 and 60 minutes	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

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

Trial Locations

Locations (1)

University Hospital; 🇧🇷 Londrina, Paraná, Brazil