The Feasibility of Drug Delivery to Infants During Breastfeeding

NCT03799367 | Completed

• 1 other identifier: 18/LO/0551
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (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

  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 Outcomes (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.

Interventions

Drug delivery during breastfeeding DEVICE

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.

Eligibility Criteria

• Age: 7 Days - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• University of Cambridge: collaborator

Study Sites (1)

addenbrookes Hospital

Cambridge, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35245341 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Lecturer, University of Cambridge

Study Record Dates

• First Submitted: July 8, 2018
• First Posted: January 10, 2019
• Study Start: July 9, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

GB (1)