Feasibility of drug delivery to infants during breastfeeding (FEDD)
Research type
Research Study
Full title
The feasibility of drug delivery to infants during breastfeeding (FEDD)
IRAS ID
240944
Contact name
Kathryn Beardsall
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Parents commonly find giving medicines to babies, using oral syringes or spoons, difficult and emotionally stressful. In developing countries, additional stress arises due to hygiene difficulties and the lack of clean water. To overcome these challenges and encourage breastfeeding, we have developed the concept of a Therapeutic Nipple Shield, a delivery system that makes it possible to give medicine and nutrients to babies during breastfeeding. It consists of a silicone nipple shield that allows the release of medicine/nutrients into human milk during the feed. Presentations of a prototype to parents and staff at the Rosie Hospital was very positive, and encouraged this clinical study.
This study aims to give a vitamin B12 supplement to babies during breastfeeding. The supplement will be placed into a nipple shield, both of which are commercially available, and the mother will breastfeed her baby as usual. Before and after the feed, we will 1) collect a small blood sample from the baby to see whether the vitamin levels in the infant have increased, 2) ask the mother to participate in two short interviews about her expectations and experiences using the Therapeutic Nipple Shield.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
18/LO/0551
Date of REC Opinion
1 Jun 2018
REC opinion
Further Information Favourable Opinion