Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia

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 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

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