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Immature NewbornGestATionNCT02534194

Gestational Age Assessment Tool

An observational study of Immature Newborn and Premature Birth, run by University of Nottingham at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 6 monthsHealthy volunteers can take part
Conditions the study is for
Immature Newborn, Premature Birth
What is being tested?
Image acquisition
How many people
150 participants
Where
1 siteUnited Kingdom
Study dates
Aug 2015to 11 May 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 6 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Newborn babies within 7 days of birth recruited from Nottingham University Hospitals NHS Trust.

Who may be able to join

  • Where the baby's gestational age is known (based on antenatal care)
  • With written informed parental consent.

Who cannot join

  • No parental consent
  • Babies undergoing palliative care

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Nottingham University Hospitals NHS Trust

    Nottingham, Nottinghamshire, NG72UH

Other trials in United Kingdom

About this study

Official title: Gestational Age Assessment Tool for Newborn Babies

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.

Read the 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.

Being tested
Image acquisition
Keywords
Gestation, Premature, Infants
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Image acquisitionOther

    Images of baby's face (including ear) and feet

Study groups in NCT02534194
Study groupRoleWhat they receive
Newborn InfantNewborn babies (within 7 days of birth) born between 23-42 weeks.
Receives: Other: Image acquisition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Software analysis tool estimates the gestational age of a newborn baby to within 1 week of its actual gestation

    Measured: 12 months

Secondary outcomes (1)
  1. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2015 (estimated)
  2. Study startAug 2015
  3. Primary completion15 Apr 2018
  4. Study completion11 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02534194
Sponsor's protocol ID
15020
Acronym
GestATion
Status last verified
May 2018
First submitted
4 Aug 2015
Last updated
14 May 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Immature Newborn and Premature Birth, run by University of Nottingham at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Software analysis tool estimates the gestational age of a newborn baby to within 1 week of its actual gestation (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.

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