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Evaluation of two plastic bags to prevent admission hypothermia in preterm babies less than 34 weeks of gestational age

Evaluation of two polyethylene plastic bags to prevent admission hypothermia in preterm babies less than 34 weeks of gestational age

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-952kfh
Enrollment
Unknown
Registered
2018-07-24
Start date
2018-06-18
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

Prevention of hypothermia

Interventions

Intervention group will use: double polyethylene bag with hood and insulation foam (NeoHelpTM - Code ANVISA: 10234400209).At least 94 infants. Group control will use regular polyethylene plastic bag.
Device
M01.060.703.520.520
N04.761.789

Sponsors

Faculdade de Ciências Médicas da Universidade Estadual de Campinas
Lead Sponsor
Faculdade de Ciências Médicas da Universidade Estadual de Campinas
Collaborator

Eligibility

Age
0 Days to 28 Days

Inclusion criteria

Inclusion criteria: Preterm inborn infants; with less than 34 weeks of gestational age; both gender.

Exclusion criteria

Exclusion criteria: No measurement of temperature at hospital admission

Design outcomes

Primary

MeasureTime frame
Admission hypothermia at the Neonatal Intensive Care Unit, defined by axillary temperature less than 36ºC, measured by BD brand ® digital thermometer, (accuracy of record minimum temperature of 32oC) Admission hypothermia frequency will be compared between the two groups, we expect to have no difference between the two groups.—

Secondary

MeasureTime frame
Hospital neonatal death—

Countries

Brazil

Contacts

Public ContactAna Luiza Possidente

Faculdade de Ciências Médicas da Universidade Estadual de Campinas

izapossidente@gmail.com+55 011-983217983

Outcome results

None listed

Source: REBEC (via WHO ICTRP)