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Effects of Heated Blanket on Premature babies

Effects of Thermal Blanket in Premature newborns: a randomized controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-48bhsdx
Enrollment
Unknown
Registered
2023-01-18
Start date
2021-10-18
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

Hypothermia

Interventions

This is a randomized, controlled, single-blind clinical study with 30 premature newborns, followed up on admission to the Neonatal Intensive Care Unit, divided into 03 groups: Intervention Group 1 (GI
Intervention Group 2 (GI2) with 10 preterm infants in a heated crib without a heated blanket
Control Group (CG) with 10 preterm infants in a heated double-walled incubator. For data collection, a structured observation script will be used, containing the study variables, in addition to heatin
E07.325.569
E07.461

Sponsors

escola de enfermagem Anna Nery
Lead Sponsor
hospital universitário Pedro Ernesto
Collaborator

Eligibility

Age
25 Weeks to 34 Weeks

Inclusion criteria

Inclusion criteria: Premature newborns below 34 weeks up to 25 weeks of Gestational Age; low and very extreme low weight; in ventilatory assistance or not; normothermic or hypothermic, with vital functions in the normal range

Exclusion criteria

Exclusion criteria: Newborns received from another institution, at term, post-term, malformed, asphyxia who present dysthermia of central origin, hyperthermia and hemodynamic instability

Design outcomes

Primary

MeasureTime frame
It is expected that the thermal blanket associated with the radiant heat cradle will be an additional resource in controlling the premature body temperature, verified through the measurement of the axillary temperature and continuous monitoring of the body temperature, analyzed by Kruskal-Wallis statistical tests and analysis of variance (ANOVA), with a significance level of p<0.05.

Secondary

MeasureTime frame
The secondary endpoint will be Oxygen Saturation (SatO2), Heart Rate (HR) and Respiratory Rate (RR). It is expected to find variations in the other vital functions of premature newborns, caused by excessive handling and interventions upon admission, verified through continuous monitoring, analyzed by Kruskal-Wallis statistical tests and analysis of variance (ANOVA), with level of p<0.05 significance.

Countries

Brazil

Contacts

Public ContactJosé Antonio Neto

Escola de Enfermagem Anna Nery

pesquisa@eean.ufrj.br+55(21)3938-0944

Outcome results

None listed

Source: REBEC (via WHO ICTRP)