The LLEGS Study (V1.0)
Research type
Research Study
Full title
The Leicester Late preterm and Early term Growth and body composition Study (LLEGS)
IRAS ID
343881
Contact name
Elaine M Boyle
Contact email
Sponsor organisation
University of Leicester
Clinicaltrials.gov Identifier
researchregistry10543., The Research Registry (https://www.researchregistry.com/)
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
Late preterm (34+0-36+6 weeks of gestation) and early term births (37+0-38+0 weeks)represent nearly a third of live births in England and Wales. Infants born late preterm and early term (LPET) are more likely to need help for problems related to their immature birth compared with full term(FT;≥39+0 weeks) babies,including breathing difficulties, jaundice, infection, and feeding problems. Effects of their early birth persist beyond the neonatal period. A small number of studies show LPET-born children are at greater risk of poor growth in infancy, childhood overweight and obesity, problematic feeding, and developmental delay compared with those born FT. Increased risk of noncommunicable diseases such as type two diabetes and cardiovascular disease has also been reported. Breastfeeding in infancy is associated with better health outcomes across the life course. Evidence suggests that LPET infants are less likely to start and continue breastfeeding. It is not completely clear why, but difficulties in latching the infant at the breast, reduced milk supply, and lack of support are implicated.
This study will evaluate the relationship between feeding type (Mothers own Milk and first infant formula) and body composition outcomes in a cohort of LPET infants born in Leicester in one of the two UHL maternity units (Leicester Royal Infirmary or Leicester General Hospital) until three months of age. A full term comparison group will be recruited. Body composition outcomes characterise the ‘type’ of growth by measuring lean mass (muscle, bone and body organs) and fat mass (body fat) in the body. Together with other growth measurements, this information will be used to describe the health of the cohort. Little is known about body composition outcomes in LPET infants in relation to the type of feeding; to our knowledge, no study has yet investigated body composition outcomes in British-born LPET infants in a multi-ethnic urban setting.REC name
East Midlands - Derby Research Ethics Committee
REC reference
25/EM/0018
Date of REC Opinion
17 Mar 2025
REC opinion
Further Information Favourable Opinion