Bronchopulmonary Dysplasia
Conditions
Keywords
Bronchopulmonary Dysplasia, Hydrotherapy, Electromyography, Pain, Prematurity
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.
Interventions
PROCEDUREHydrotherapy
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.
PROCEDUREConventional 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.
Sponsors
Universidade Norte do Paraná
Universidade Estadual de Londrina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 36 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
Countries
Brazil
Contacts
Primary ContactVictoria Escobar, Pt
Backup ContactDarllyana Soares, Pt
Outcome results
None listed