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BEMPU Temperature Device Study for Low Birth Weight Babies

Investigating the effect of a temperature monitoring device on hypothermia-related escalation of care in low birth weight babies: a randomised controlled trial.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000167864
Acronym
BEMPU Temp study (BEMPU Temp watch study)
Enrollment
75
Registered
2021-02-18
Start date
2021-03-01
Completion date
2021-08-20
Last updated
2023-08-21

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

Conditions

None listed

Brief summary

The aim of the study is to determine whether neonatal monitoring of low birth weight babies with the BEMPU TempWatch along with standard neonatal care, as compared with standard neonatal care alone, decreases the need for escalation of care to invasive warming measures such as placement in an incubator or radiant warmer.

Interventions

Mothers/ parents who are allocated to this group will receive a BEMPU TempWatch for their newborn baby to wear for up to 28 days, and educated on providing skin-to-skin contact for their babies if hypothermia is indicated by the audio-visual alarm. They will also receive the standard neonatal care whilst in hospital and provided the standard information for temperature maintenance upon discharge home. The BEMPU TempWatch is placed on the newborn baby's wrist where it provides continuous temperat

Mothers/ parents who are allocated to this group will receive a BEMPU TempWatch for their newborn baby to wear for up to 28 days, and educated on providing skin-to-skin contact for their babies if hypothermia is indicated by the audio-visual alarm. They will also receive the standard neonatal care whilst in hospital and provided the standard information for temperature maintenance upon discharge home. The BEMPU TempWatch is placed on the newborn baby's wrist where it provides continuous temperature monitoring for up to 28 days, and will trigger an audio-visual alarm if the baby's temperature drops below 36 degrees Celsius. The duration of the intervention is for a maximum of up to 28 days (based on battery life and size of baby's wrist) Education for providing skin-to-skin contact will be provided to parents by midwifery educators. Regular checks will be used to monitor adherence to the intervention. Newborn babies will be receiving standard neonatal care, which includes regular temperature monitoring, weight checks and blood sugar monitoring. They will receive the standard neonatal care whilst in hospital (as described in the comparator/control field).

Sponsors

Monash Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 1 Days
Healthy volunteers
No

Inclusion criteria

Neonates born at Monash Medical Centre, Clayton who are of low birth weight (i.e. <2500 grams at birth) or small for gestational age (i.e. birth weight <10th centile) AND are being looked after by the mother/ parents in the postnatal ward

Exclusion criteria

Infants who are born earlier than 35 weeks completed gestation, or who continue to stay in SCN beyond 24 hours of life for any reason will be excluded from the study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026