Effects of Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia During Hospitalization: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Peripheral oxygen saturation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 23 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Those unable to perform hydrotherapy for three consecutive days due to severe respiratory effort evaluated by the Silverman Andersen Bulletin and hemodynamic instability.
研究组 & 干预措施
Conventional physiotherapy (GP)
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.
干预措施: Conventional Physiotherapy (Procedure)
GP + hydrotherapy (GH)
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.
干预措施: Hydrotherapy (Procedure)
结局指标
主要结局
Peripheral oxygen saturation
时间窗: 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.
次要结局
- 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.)
- Heart rate(Change from baseline heart rate at 15, 30 and 60 minutes.)
- Stress level(Change from baseline salivary cortisol at 30 minutes.)
研究者
Vanessa Suziane Probst
Principal investigator
Universidade Estadual de Londrina