Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia

NCT03538977 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-10-16

No results posted yet for this study

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.

Conditions

  • Bronchopulmonary Dysplasia

Interventions

PROCEDURE

Hydrotherapy

A re-sterilizable stainless steel bucket with an upper diameter of 30 cm, a depth of 32 cm, with water at a temperature between 37 and 38º Celsius will be used. The amount of water used will be sufficient to keep the baby submerged up to shoulder height. The baby will be immersed in the heated water of the bucket and will be suspended by occipital support performed by the physiotherapist, who alternates lateral-lateral and anteroposterior movements with only static suspension. The therapy will last from eight to ten minutes and will be discontinued if there is agitation, cyanosis, worsening respiratory distress or major evacuation. If the baby is using any type of ventilatory support or oxygen therapy, the same will be maintained during the procedure of hydrotherapy.

PROCEDURE

Conventional Physiotherapy

Conventional physiotherapy consists of manipulations of Thoracoabdominal Rebalancing, a registered technique which uses simultaneous passive stretching of inspiratory muscles and stimulation of the diaphragm. The manipulation used to improve the dynamic diaphragm included the thoracic-abdominal and lower abdominal support maneuvers. Back repositioning was used to minimize posteriorization of the ribs and costal kyphosis due to thoracic distortion.

Sponsors & Collaborators

  • Universidade Norte do Paraná

    collaborator OTHER
  • Universidade Estadual de Londrina

    lead OTHER

Principal Investigators

  • Vanessa Probst, PhD · State University of Londrina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
23 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-11
Primary Completion
2019-05-31
Completion
2019-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03538977 on ClinicalTrials.gov