Clinical trial NCT03799367: The Feasibility of Drug Delivery to Infants During Breastfeeding
Official title: The Feasibility of Drug Delivery to Infants During Breastfeeding (FEDD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Systems
Breast Feeding
Milk, Human
Infant, Newborn
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Cambridge
First posted: 2019-01-10
Enrollment: 26
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.


Eligibility criteria: Inclusion Criteria:

No known allergy or hypersensitivity against any ingredient used in the study Infant aged up to 12 months Confident breastfeeder (exclusively or non-exclusively)

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

* Not confident at breastfeeding
* Infant not feeding properly
* Allergy or hypersensitivity against any ingredient of the commercially available Methylcobalamin Vitamin B12 Tablets (Just Vitamins Ltd, UK) used in the study (infant or mother)
* Medical conditions that could negatively influence swallowing, and thus breastfeeding

Primary outcomes:
measure: Detection of the change in vitamin B12 concentration in the infants' blood 6-8 hours following vitamin B12 delivery from a nipple shield device during breastfeeding
timeFrame: Blood sampling base line and 6-8 hours post feed
Secondary outcomes:
measure: Qualitative assessment of impact on maternal expectation, experience and acceptability
timeFrame: Interviews will be conducted prior to and post interventional feed and will last about 30-50 min.
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: addenbrookes Hospital
Study officials:
References:
citation: Maier T, Peirce P, Baird L, Whitehouse SL, Slater NKH, Beardsall K. Drug delivery from a solid formulation during breastfeeding-A feasibility study with mothers and infants. PLoS One. 2022 Mar 4;17(3):e0264747. doi: 10.1371/journal.pone.0264747. eCollection 2022.