Investigating a New Way of Giving Medicine to Newborn and Preterm Babies

• Status: Unknown status
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Strathclyde
• Treatments: Pharmaceutical Solutions; Potassium phosphate

Criteria

Inclusion Criteria:

• GENDER Male or female

• AGE Born < 32 completed weeks' gestational age

• CONSENT Parents/other caregivers demonstrate understanding of the study and willingness to consent to their child's participation as evidenced by voluntary written informed consent (signed and dated) obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)

• MEDICATIONS AND TREATMENTS Participants must have been established on oral feeds (as defined by as > 75% of predicted volume enterally for three consecutive days).

Exclusion Criteria:

• MEDICATIONS Patients prescribed concomitant medication known to interact with potassium phosphate or any of the other ingredients in the oral thin film.

• CLINICAL STUDIES

• Previous participation in this study.

• Subject whose participation in this study will result in a participation in more than four studies over a twelve month period.