Gestational Age Assessment Tool

NCT02534194 | Completed

• 1 other identifier: 15020
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Immature Newborn; Premature Birth

Keywords

Gestation; Premature; Infants

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (1)

• Quantification of pain from facial features during uncomfortable procedures.

  12 months

Study Arms (1)

Newborn Infant

Newborn babies (within 7 days of birth) born between 23-42 weeks.

Other: Image acquisition

Interventions

Image acquisition OTHER

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

Newborn Infant

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• No parental consent
• Babies undergoing palliative care

Sponsors & Collaborators

• University of Nottingham: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG72UH, United Kingdom

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Don Sharkey, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 27, 2015
• Study Start: August 1, 2015
• Primary Completion: April 15, 2018
• Study Completion: May 11, 2018
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

GB (1)