Investigating a New Way of Giving Medicine to Newborn and Preterm Babies
University of Strathclyde
There is a deficit in the number of 'age-appropriate' formulations available for the
delivery of medicines to children. Liquid preparations are considered the 'gold standard'
for delivering medicines to children however many of these are formulated using ingredients
which can be toxic to children (e.g. preservatives, alcohols), particularly to neonatal
babies (< 4 weeks old) who do not possess the metabolic processes and mature organ function
of older children or adults. Rapidly dissolving oral thin films (OTFs) dissolve quickly in
the saliva, releasing the active ingredient(s) without the need for chewing or water, making
them ideally suited to patients who find it difficult to swallow other oral dosage forms
such as tablets or capsules. The aim of this study is to demonstrate that OTFs can offer a
safe and effective alternative for oral administration of phosphate supplements to neonatal
infants for the treatment of hypophosphataemia and osteopenia of prematurity. It is
hypothesised that this treatment will be equal to standard therapy using an oral solution.
Babies born before 32 weeks gestational age are routinely supplemented with oral phosphate
as soon as they have been established on oral feeds in order to prevent bone disorders such
as osteopenia. Babies recruited to this study will be given phosphate supplementation as per
NHS Greater Glasgow and Clyde guidelines. This single-centre cross-over study will take
place in the intensive care and special care baby units at the Princess Royal Maternity in
Glasgow. The investigators aim to recruit 20-30 babies and will use blood phosphate levels
(obtained from routine sampling only) to evaluate treatment effect. Babies will be
randomised to receive either OTFs or oral solution of potassium acid phosphate for 2 weeks
followed by 2 weeks of the other therapy. The investigators hypothesise that OTF treatment
will be equivalent to standard oral solution.
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