Brief Title
Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia
Official Title
Effects of Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia During Hospitalization: a Randomized Clinical Trial
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 Type
Interventional
Primary Outcome
Peripheral oxygen saturation
Secondary Outcome
Pain evaluation
Condition
Bronchopulmonary Dysplasia
Intervention
Hydrotherapy
Study Arms / Comparison Groups
Conventional physiotherapy (GP)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
24
Start Date
October 11, 2018
Completion Date
December 2019
Primary Completion Date
May 2019
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.
Gender
All
Ages
23 Weeks - 36 Weeks
Accepts Healthy Volunteers
No
Contacts
Vanessa Probst, PhD, 5543 991462230, [email protected]
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT03538977
Organization ID
UEL-PPG Reabilitação
Responsible Party
Principal Investigator
Study Sponsor
Universidade Estadual de Londrina
Collaborators
Universidade Norte do Paraná
Study Sponsor
Vanessa Probst, PhD, Principal Investigator, State University of Londrina
Verification Date
October 2018