addenbrookes Hospital
Cambridge, United Kingdom
NCT Number: NCT03799367
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.
Looking for future studies?
Notify Me7 day–12 month
All sexes
Interventional
Not applicable
Cambridge, United Kingdom
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:
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.
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
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
Cambridge University Hospitals NHS Foundation Trust
Other
The Feasibility of Drug Delivery to Infants During Breastfeeding (FEDD)
Acronym: FEDD
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.
Published trials that share one or more normalized conditions with this study.
NCT00439348
Behavior, Drugs, Non-Prescription
Orlando, Florida, United States
View Trial DetailsNCT05133700
Medication Systems, Quality Improvement
Preston, Lancashire, United Kingdom
View Trial DetailsNCT07077941
Behavior, Body Weight Decreased
Vienna, State of Vienna, Austria
View Trial DetailsNCT05979532
Behavior, Breast Feeding
Utrecht, Netherlands
View Trial Details