Premature Birth Clinical Trial
— GestATionOfficial title:
Gestational Age Assessment Tool for Newborn Babies
NCT number | NCT02534194 |
Other study ID # | 15020 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2015 |
Est. completion date | May 11, 2018 |
Verified date | May 2018 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In the UK and worldwide many babies are born without carers knowing their gestation as the
mothers will not have had good antenatal care. It is possible to estimate gestation but this
requires a detailed clinical exam. The investigators wish to improve this by using software
analysis to pick out features of the baby (face and foot) to try and estimate the gestation
of the baby once it is born. The investigators will also look explore if the software can
distinguish the normal face or a baby in discomfort.
Good estimation of gestation can result in more targeted management of the baby. The
investigators will capture the images of newborn babies, from a variety of gestations, and
use this dataset to teach the software to estimate gestational age and level of discomfort.
Status | Completed |
Enrollment | 150 |
Est. completion date | May 11, 2018 |
Est. primary completion date | April 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 6 Months |
Eligibility |
Inclusion Criteria: - Where the baby's gestational age is known (based on antenatal care) - With written informed parental consent. Exclusion Criteria: - No parental consent - Babies undergoing palliative care |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham | Bill and Melinda Gates Foundation |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Software analysis tool estimates the gestational age of a newborn baby to within 1 week of its actual gestation | 12 months | ||
Secondary | Quantification of pain from facial features during uncomfortable procedures. | Comparison with two pain scores, the neonatal Pain Assessment Tool (PAT, scored 0 (no pain) to 10 (significant pain)) and the Neonatal Infant Pain Scale (NIPS, scored 0 (no pain) to 7 (significant pain)). The software will be calibrated from these pain scores. This approach hasn't previously been performed so the software scoring system will be developed alongside these commonly used measures. | 12 months |
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