Investigating a New Way of Giving Medicine to Newborn and Preterm Babies
Status:
Unknown status
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
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.