Investigating a New Way of Giving Medicine to Newborn and Preterm Babies
|ClinicalTrials.gov Identifier: NCT01676844|
Recruitment Status : Unknown
Verified August 2012 by Professor Alex Mullen, University of Strathclyde.
Recruitment status was: Not yet recruiting
First Posted : August 31, 2012
Last Update Posted : August 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hypophosphataemia Osteopenia of Prematurity||Drug: Oral thin film therapy (Potassium acid phosphate oral thin films) Drug: Standard therapy (Potassium acid phosphate oral solution)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Oral Potassium Acid Phosphate Supplementation for Preterm Neonates; a Comparison of Oral Thin Films and Standard Oral Therapy.|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||November 2013|
Experimental: Oral thin film therapy
One or more oral thin films (OTFs) containing potassium acid phosphate administered to the inside cheek, tongue or palate at a dose of 0.5 mmol/kg body weight twice daily. Dosages will be rounded to the nearest 0.1 mM/kg. Where more than one OTF is required to achieve a dosage of 0.5mmol/kg, strips will be administered consecutively with time allowed between doses to allow for complete dissolving of the previous strip. Treatment will continue until the participant has received OTF therapy for 14 consecutive days.
Drug: Oral thin film therapy (Potassium acid phosphate oral thin films)
Orally dissolving thin film. White, square oral thin film. 15 mm x 15 mm surface area. 1-2 mm film thickness. No markings.
Place a single OTF on the tongue, inside cheek or palate and allow to dissolve.
Other Name: Potassium acid phosphate oral thin films 0.2, 0.3 and 0.4 mM
Active Comparator: Standard therapy
Standard oral phosphate supplementation as per NHS Greater Glasgow and Clyde Guidelines. An oral solution containing potassium acid phosphate (1 mmol/mL) will be administered at a dosage of 0.5 mM/kg body weight twice daily. Dosages will be rounded to the nearest 0.1 mM/kg. Standard therapy will continue until the participant has received treatment for 14 consecutive days.
Drug: Standard therapy (Potassium acid phosphate oral solution)
Each millilitre contains approximately 136mg Monobasic Potassium Phosphate Ph.Eur. (KH2PO4) equivalent to 1mmol Potassium (39mg) and 1mmol Phosphate (31mg Phosphorus). Manufacturer: Specials Products Ltd., Surrey, UK.
Other Name: Potassium acid phosphate 1mmol in 1ml oral solution
- Serum phosphate [ Time Frame: Participants will be followed from birth until the end of the study period, approximately 6 weeks on average ]The aim of this research is to demonstrate that oral thin films (OTFs) containing potassium acid phosphate are equivalent to standard oral phosphate supplementation using an oral solution in the prevention of hypophosphataemia (low blood phosphorus). The primary outcome measure will be plasma phosphate. We will assume an equivalent therapeutic effect using OTFs if individual plasma levels for these babies are found to lie within an acceptable physiological range, and the difference between the means of the two groups (as determined by a statistical t-test) lies within 20% of the mean plasma level for the control group.
- Age-appropriateness [ Time Frame: Participants will be followed from birth until the end of the study period, approximately 6 weeks on average ]Secondary objectives will be in terms of age-appropriateness and general acceptability. A lack of any observable adverse effects e.g. choking, vomiting, diarrhoea, will indicate the safety of oral thin films in this age group. Acceptability will be assessed in terms of observed discomfort/distress e.g. grimacing, crying, associated with treatment administration and will be assessed using visual analogue scales.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676844
|Contact: Helen Mactier, MB ChB||011441412115249||Helen.Mactier@ggc.scot.nhs.uk|
|Contact: Stewart I Watts, MPharmfirstname.lastname@example.org|
|Princess Royal Maternity||Not yet recruiting|
|Glasgow, Strathclyde, United Kingdom, G31 2ER|
|Contact: Helen Mactier, MB ChB 011441412115249 Helen.Mactier@ggc.scot.nhs.uk|
|Contact: June Grant, MPharm 011441412115400 June.Grant@ggc.scot.nhs.uk|
|Principal Investigator: Helen Mactier, MB ChB|
|Principal Investigator:||Alex Mullen||University of Strathclyde|