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Clinical trial on the effects of a Hydrotherapy protocol Neonatal Intermediate Care Unit

Clinical trial on the effects of a Hydrotherapy protocol Neonatal Intermediate Care Unit

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3ysnwj
Enrollment
Unknown
Registered
2016-05-05
Start date
2016-03-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prematurity

Interventions

hydrotherapy protocol
Other

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
Lead Sponsor
Universidade de São Paulo - Faculdade de Medicina de Ribeirão Preto
Collaborator

Eligibility

Age
32 Weeks to 33 Weeks

Inclusion criteria

Inclusion criteria: preterm infants with gestational age less than or equal to 32 weeks ; Hospitalized Neonatal Intermediate Care Unit; in spontaneous breathing ; without central or peripheral venous access ; babies without congenital malformations or chromosomal syndromes or infections in treatment ( change of blood count and blood culture positive ) or neurological disorders ( intracranial hemorrhage grade III or IV, and brain malformations ) ; without skin lesions or other contraindications to body immersion in hot water

Exclusion criteria

Exclusion criteria: adverse reactions to the study protocol (cyanosis , crying or lethargy, facies pain , generalized hyperemia , among others); Epidermal changes ; worsening of symptoms ; intolerance to food or behavioral disorders; events that prevent the study protocol ( need for ventilatory support or intravenous and surgical procedures ) ; parents and / or guardians who request to withdrawn from the infant study protocol

Design outcomes

Primary

MeasureTime frame
Weight gain during hospitalization in Iintermédiários neonatal care unit

Secondary

MeasureTime frame
Effect on vital signs ( heart rate , peripheral oxygen saturation , axillary temperature ) , salivary cortisol levels and the behavioral state ( sleep and wakefulness scale ) before and after intervention; and effect on the length of stay and neurobehavioral development

Countries

Brazil

Contacts

Public ContactElaine Raniero

Universidade de São Paulo - Faculdade de Medicina de Ribeirão Preto

eraniero@usp.br+55(16)981123388

Outcome results

None listed

Source: REBEC (via WHO ICTRP)