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OpenTrials
Completed

NCT Number: NCT03799367

The Feasibility of Drug Delivery to Infants During Breastfeeding

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.

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Key information

Age range

7 day–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

addenbrookes Hospital

Cambridge, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

    Time frame: 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 outcomes

  1. Qualitative assessment of impact on maternal expectation, experience and acceptability

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Other

Collaborators

  • University of Cambridge

Registry information

Official study title

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

Acronym: FEDD

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 10, 2019
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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