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Gestational Age Assessment Tool (GestATion)

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ClinicalTrials.gov Identifier: NCT02534194
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
University of Nottingham

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Immature Newborn Premature Birth Other: Image acquisition

Detailed Description:

Clinical techniques for the calculation of gestation include fetal ultrasound and clinical assessment tools, such as the Ballard Score, following birth. These techniques are rarely available (ultrasound which is expensive and requires trained users) or require significant training (Ballard) which makes them unsuitable for large scale assessment in many low-middle income (LMI) countries. In the UK, the gestational age of babies of mothers with no antenatal care requires a detailed clinical examination which can lack accuracy. Clinical assessment of postnatal gestational age utilises anatomical characteristics of the face, ear and foot during newborn development. There is an element of subjectiveness which reduces the precision of such an assessment which is only reduced with significant training and experience. Simpler techniques of postnatal gestational age assessment such as anthropometric measures are time consuming and lack the accuracy required. Emerging evidence suggests that gestational age can be calculated postnatally by measuring the newborn foot length and comparing to population appropriate charts. However, when used on their own, the specificity and sensitivity are still below acceptable limits to allow universal adoption.

New software-based analytical techniques now make it possible to perform fully automatic recognition of facial actions and dimensions. The investigators have developed techniques that allow live video facial feature identification and measurement using advanced analytical techniques of muscle actions. These techniques have been used for facial expression analysis as well as automated facial feature localization. The investigators propose that the same analysis could be used to create a unique gestational age assessment tool using a simple brief video clip of the newborns' face and foot.

Accurate assessment of gestational age, especially in LMI countries, could ensure high risk newborns receive appropriate low cost interventions to reduce morbidity and mortality. In the UK this could allow better estimation of babies born to mothers with no antenatal care where the gestational age is unclear. We propose a smartphone based, ethnic appropriate, combined face and foot video analysis tool to accurately determine gestational age of the newborn. Such a system could adapted to incorporate pain assessment tools to help inform treatment options and study new therapies.

Study Design
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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gestational Age Assessment Tool for Newborn Babies
Study Start Date : August 2015
Actual Primary Completion Date : April 15, 2018
Actual Study Completion Date : May 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Newborn Infant
Newborn babies (within 7 days of birth) born between 23-42 weeks.
 Other: Image acquisition
Images of baby's face (including ear) and feet


Outcome Measures
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Primary Outcome Measures :
  1. Software analysis tool estimates the gestational age of a newborn baby to within 1 week of its actual gestation [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Quantification of pain from facial features during uncomfortable procedures. [ Time Frame: 12 months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Newborn babies within 7 days of birth recruited from Nottingham University Hospitals NHS Trust.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534194


Locations
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United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG72UH
Sponsors and Collaborators
University of Nottingham
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Don Sharkey, PhD University of Nottingham
More Information
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02534194    
Other Study ID Numbers: 15020
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Keywords provided by University of Nottingham:
Gestation
Premature
Infants
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications