Medication SystemsFEDDNCT03799367
The Feasibility of Drug Delivery to Infants During Breastfeeding
A study testing Drug delivery during breastfeeding in people with Medication Systems and Breast Feeding, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 7 days to 12 months
- Conditions the study is for
- Medication Systems, Breast Feeding, Milk, Human
- What is being tested?
- Drug delivery during breastfeeding
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jul 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- No known allergy or hypersensitivity against any ingredient used in the study Infant aged up to 12 months Confident breastfeeder (exclusively or non-exclusively)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility of Drug Delivery to Infants During Breastfeeding (FEDD)
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
- Being tested
- Drug delivery during breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug delivery during breastfeedingDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Blood sampling base line and 6-8 hours post feed
Secondary outcomes (1)
Qualitative assessment of impact on maternal expectation, experience and acceptability
Semi-structured interviews will be conducted before and after vitamin B12 delivery during breastfeeding
Measured: Interviews will be conducted prior to and post interventional feed and will last about 30-50 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start9 Jul 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication SystemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Principal investigator, Kathryn Beardsall, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799367
- Sponsor's protocol ID
- 18/LO/0551
- Acronym
- FEDD
- Status last verified
- Jan 2019
- First submitted
- 8 Jul 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35245341
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Drug Delivery to Infants During Breastfeeding (FEDD)
- ClinicalTrials.gov ID
- NCT03799367
- Acronym / sponsor ID
- FEDD / 18/LO/0551
- Conditions
- Medication Systems, Breast Feeding, Milk, Human, Infant, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 7 days to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- No known allergy or hypersensitivity against any ingredient used in the study Infant aged up to 12 months Confident breastfeeder (exclusively or non-exclusively)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug delivery during breastfeedingThis 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. | Device | – |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Derived from this study: PubMed 35245341Maier 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.
- Individual participant dataSharing planned: Undecided
Related trials for Medication Systems
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug delivery during breastfeeding in people with Medication Systems and Breast Feeding, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Blood sampling base line and 6-8 hours post feed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03799367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.