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Vital Signs and stress behavior in preterm newborns undergoing to tub bath.

Physiological Signs and Behavioral State in Preterms Newborns Undergoing to Two Techniques of Immersion Bath: A Crossover Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3zk3cn
Enrollment
Unknown
Registered
2017-05-25
Start date
2014-02-11
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

Body temperature regulation, heart rate,oxygen consumption, hydrocortisone levels and behavior in preterm infants

Interventions

The total number of 36 newborns will be allocated in two groups of 18 newborns, each which will be undergoing to swaddled immersion bath in a sheet - SIB (Experimental Group - EG) as the conventional
Procedure/surgery
D04.808.745.745.654.600

Sponsors

Escola de Enfermagem da Universidade de São Paulo
Lead Sponsor
Hospital Universitário da Universidade de São Paulo
Collaborator
Escola de Enfermagem da Universidade de São Paulo
Collaborator

Eligibility

Age
0 Days to 0 Days

Inclusion criteria

Inclusion criteria: Maximum adjusted gestational age of 36 weeks and 6 full days on the date of data collection;Preterm newborn over 24 hours of life;Spontaneous breathing;Release to immersion bath;No diagnosis of congenital anomalies and heart disease;Newborns no in use of sedative medication;Newborns who are not in the postoperative period; Clinically stable with heart rate between 120-160 and oxygen saturation greater than 85% whitin 6 hour prior to data collection (immersion bath) and infants fed for at least 1 hour

Exclusion criteria

Exclusion criteria: Diagnosis of neuropathies and diseases identified after inclusion and data collection or any adverse event as cyanosis or vomiting during the intervention

Design outcomes

Primary

MeasureTime frame
Axillary temperature variation 10 and 30 minutes post immersion bath compared to axillary temperature immediately pre bath, measured by a digital thermometer in Celsius degree.

Secondary

MeasureTime frame
Heart rate variation 10 and 30 minutes post immersion bath compared to heart rate values immediately pre bath. The heart rate will be measured by a multiparametrical monitor put in one of the newborn lower limbs. ;Oxygen saturation variation 10 and 30 minutes post immersion bath compared to oxygen saturation values immediately pre bath. The oxygen saturation will be measured by a multiparametrical monitor put in one of the newborn lower limbs. ;Salivary cortisol variation 20 minutes post bath compared to values pre bath. The salivary cortisol will be collected by a ophthalmic sponge which will be keep up for 10 minutes in one of the corners of the mouth to obtain at least 1 ml of saliva. ;Sleep-wake state variation of preterm newborn 10 minutes pre bath compared to sleep-wake state 20 minutes post bath. The sleep-wake state will be filmed for 10 minutes pre bath and for 20 minutes post bath.

Countries

Brazil

Contacts

Public ContactPatrícia;Patrícia Freitas;Freitas

Escola de Enfermagem da Universidade de São Paulo;Escola de Enfermagem da Universidade de São Paulo

patynurse@usp.br;patynurse@usp.br+5511982011744;+551130617602

Outcome results

None listed

Source: REBEC (via WHO ICTRP)