Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia

Bronchopulmonary Dysplasia Clinical Trial

Official title: Effects of Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia During Hospitalization: a Randomized Clinical Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hyperplasia

• NCT number: NCT03538977
• Study type: Interventional
• Source: Universidade Estadual de Londrina
• Contact: Victoria Escobar, Pt
• Phone: 5543 991462230
• Email: escobar.vic@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2018
• Completion date: December 2019