None listed
Conditions
Brief summary
This study aims to assess if a device called ‘Preemietest’ is more accurate than the current assessment for maturity after birth, called the Ballard score, in determining gestational age. The Preemietest is a light-based device that assesses the baby’s gestational age by placing it on the sole of the foot for a few seconds. The device will provide us with an instant result, and this will be compared to the early dating scan to assess the accuracy of the Preemietest.
Interventions
Preterm birth and low birthweight are risk factors for adverse infant outcomes. Current practices for estimating gestational age for infants whose mothers received no or minimal antenatal care are inaccurate. In particular, the Ballard score provides only an approximate gestational age estimate +/- 28 days.
The Preemietest is a small handheld device that uses an infrared light source (peak at 850nm) and collects the resulting light scatter from the skin that has a sigmoid correlation with derma
Preterm birth and low birthweight are risk factors for adverse infant outcomes. Current practices for estimating gestational age for infants whose mothers received no or minimal antenatal care are inaccurate. In particular, the Ballard score provides only an approximate gestational age estimate +/- 28 days. The Preemietest is a small handheld device that uses an infrared light source (peak at 850nm) and collects the resulting light scatter from the skin that has a sigmoid correlation with dermal thickness. The procedure only takes seconds and is performed on the sole of the foot. Inputting birthweight and exposure to antenatal steroids allows for a gestational age estimate in weeks/days +/- 10 days. Multicentre prospective cohort studies have been completed in Brazil, Honduras and Mozambique to evaluate gestational age and the Preemietest performed almost as well as early pregnancy ultrasound and superior to the Ballard score. This study will use the Preemietest within 24h from birth (neonatal nurse or doctor) to confirm these results in an Australian cohort of newborn infants to facilitate integration into newborn care in Australia. This is a validation study; therefore, availability of a first-trimester ultrasound is required to serve as the reference standard.
Sponsors
Child and Adolescent Health Service, Western Australia
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
22 Weeks to 42 Weeks
Healthy volunteers
No
Inclusion criteria
Infants born between 22 to 42 weeks GA and delivered at King Edward Memorial Hospital and cared for in CAHS NICU or outworn and transferred by the Neonatal Emergency Transport Service to CAHS NICU. First trimester dating scan available- necessary to compare to Preemietest device result.
Exclusion criteria
a) Parents do not consent. b) Critically unwell infants that are not expected to survive. c) No first trimester dating ultrasound available. d) Congenital skin condition involving the sole of the foot.
Outcome results
None listed