Therapeutic delivery from a solid formulation during breastfeeding: a feasibility study

Abstract

Background: Enteral drug and nutrient delivery to breastfed infants depends on the use of oral syringes and liquid formulations. This can pose both practical and emotional challenges to drug delivery. Objectives: The presented study aimed to explore the potential of using solid formulations for therapeutic delivery during breastfeeding. Methods: Single centre feasibility study within a tertiary level neonatal unit in the UK, involving twenty-six breastfeeding mother-infant dyads. Vitamin B12 was delivered to infants during breastfeeding from a solid formulation within a commercial silicon nipple shield. Outcomes included the quantitative measurement of change in serum vitamin B12 and a mixed methods assessment of maternal expectations and experiences. Results: Participants described the surprising ease of 'drug' delivery, with no negative impact on breastfeeding behaviour or sensation reported. Vitamin B12 levels rose on average from a baseline of 533 pg/mL (236 - 925 pg/mL) to 1871 pg/mL (610 - 4981 pg/mL) at 6 - 8 hours post-delivery. All mothers expressed their support for this approach, 85% a preference over the use of oral syringes. Reasoning for support related to the reduced medicalisation of this procedure compared to the use of oral syringes, and a desire for choices in relation to their infants' health. Conclusions: This study demonstrated that therapeutic delivery from a solid formulation within a nipple shield was feasible and acceptable to mothers and infants.