The Feasibility of Drug Delivery to Infants During Breastfeeding

Breast Feeding Clinical Trial

— FEDD  

Official title:

The Feasibility of Drug Delivery to Infants During Breastfeeding (FEDD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03799367
• Other study ID #: 18/LO/0551
• Status: Completed
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Breast Feeding
• Infant, Newborn
• Medication Systems
• Milk, Human

Intervention

Device:
• Drug delivery during breastfeeding
This study aims to give a vitamin B12 supplement to babies during breastfeeding. 30 mother-infant pairs will be recruited. 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.

Locations

Country	Name	City	State
United Kingdom	addenbrookes Hospital	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Two infant blood samples will be taken - one base line and one post intervention	Blood sampling base line and 6-8 hours post feed
Secondary	Qualitative assessment of impact on maternal expectation, experience and acceptability	Semi-structured interviews will be conducted before and after vitamin B12 delivery during breastfeeding	Interviews will be conducted prior to and post interventional feed and will last about 30-50 min.