Clinical trial NCT03538977: Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia
Official title: Effects of Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia During Hospitalization: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Keywords: Bronchopulmonary Dysplasia
Hydrotherapy
Electromyography
Pain
Prematurity
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
Collaborators: name: Universidade Norte do Paraná
First posted: 2018-05-29
Enrollment: 24
Sex: ALL
Minimum age (years): 23
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Peripheral oxygen saturation
timeFrame: Change from baseline peripheral oxygen saturation at 15, 30 and 60 minutes
Secondary outcomes:
measure: Pain evaluation
timeFrame: Change from baseline Neonatal Infant Pain Scale score at 15, 30 and 60 minutes.
measure: State of sleep and wakefulness
timeFrame: Change from baseline Brazelton neonatal behavioral assessment scale scores at 15, 30 and 60 minutes.
measure: Breathing pattern
timeFrame: Change from baseline Silverman and Andersen bulletin scores at 15, 30 and 60 minutes.
measure: Muscular activity
timeFrame: Change from baseline surface electromiography at 60 minutes.
measure: Respiratory rate
timeFrame: Change from baseline respiratory rate at 15, 30 and 60 minutes.
measure: Heart rate
timeFrame: Change from baseline heart rate at 15, 30 and 60 minutes.
measure: Stress level
timeFrame: Change from baseline salivary cortisol at 30 minutes.
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: University Hospital
state: Paraná
Study officials:
affiliation: State University of Londrina
name: Vanessa Probst, PhD
role: PRINCIPAL_INVESTIGATOR
References: