FEDD: The Feasibility of Drug Delivery to Infants During Breastfeeding

• Sponsor: Cambridge University Hospitals NHS Foundation Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT03799367
• Collaborator: University of Cambridge (Other)
• Enrollment: 26
• Location: 1
• Actual Duration (Months): 5.7
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medication Systems; Breast Feeding; Milk, Human; Infant, Newborn	Device: Drug delivery during breastfeeding	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: The Feasibility of Drug Delivery to Infants During Breastfeeding (FEDD)
• Actual Study Start Date: Jul 9, 2018
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Outcome Measures

Primary Outcome Measures

1. 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 [Blood sampling base line and 6-8 hours post feed]

   Two infant blood samples will be taken - one base line and one post intervention

Secondary Outcome Measures

1. Qualitative assessment of impact on maternal expectation, experience and acceptability [Interviews will be conducted prior to and post interventional feed and will last about 30-50 min.]

   Semi-structured interviews will be conducted before and after vitamin B12 delivery during breastfeeding

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Days to 12 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	addenbrookes Hospital	Cambridge		United Kingdom

Sponsors and Collaborators

• Cambridge University Hospitals NHS Foundation Trust
• University of Cambridge

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kathryn Beardsall, University Lecturer, University of Cambridge, Cambridge University Hospitals NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT03799367
• Other Study ID Numbers: 18/LO/0551
• First Posted: Jan 10, 2019
• Last Update Posted: Jan 10, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Jan 10, 2019