Long Term FU After Treatment with ELGN-2112 in Preterm Infants
Research type
Research Study
Full title
Long Term Follow Up Safety Assessment After Treatment with ELGN-2112 For Intestinal Malabsorption in Preterm Infants
IRAS ID
366016
Contact name
Nicholas Embleton
Contact email
Sponsor organisation
Elgan Pharma Ltd
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This study will evaluate the long-term safety of ELGN-2112 in children who received NTRA-2112 (now ELGN-2112) as preterm infants for the treatment of intestinal malabsorption (FIT-04 study).
ELGN-2112 is a powder for reconstitution containing human recombinant insulin administered concomitantly with preterm infant's enteral nutrition for local gastrointestinal (GI) therapy. This follow-up safety study will enrol subjects that participated in the FIT-04 study (a multi-center, double-blind, randomized, three-arm, parallel group, placebo controlled study to assess the efficacy and safety of NTRA-2112 on intestinal malabsorption in preterm infants), and who meet the inclusion and exclusion criteria.
Information captured will include evaluation of rehospitalizations, general growth, and development. Data from follow-up visits which were performed as routine at 12 months and 24 months corrected age (CA) will be recorded retrospectively. If additional visits were conducted as standard of care including developmental measurements, these will be recorded as well as unscheduled visits. For subjects that experienced clinical necrotizing enterocolitis (NEC) or late onset sepsis during FIT-04 hospitalization period, additional available information will be collected, including imaging and any other diagnostic examinations done throughout disease progression. Parents / legal guardians of, and subjects will be invited by the primary centre to attend an additional “in person” follow-up visit after the child has reached 6 years prior to age 10. This visit will include an age appropriate developmental assessment. However, if this follow up is performed as standard of care, it will be recorded in lieu of follow up visit, post consent.
REC name
West of Scotland REC 4
REC reference
26/WS/0031
Date of REC Opinion
1 Apr 2026
REC opinion
Further Information Favourable Opinion