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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Strathclyde.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Professor Alex Mullen, University of Strathclyde
ClinicalTrials.gov Identifier:
NCT01676844
First received: August 23, 2012
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Potassium Acid Phosphate Supplementation for Preterm Neonates; a Comparison of Oral Thin Films and Standard Oral Therapy.

Resource links provided by NLM:


Further study details as provided by University of Strathclyde:

Primary Outcome Measures:
  • Serum phosphate [ Time Frame: Participants will be followed from birth until the end of the study period, approximately 6 weeks on average ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Age-appropriateness [ Time Frame: Participants will be followed from birth until the end of the study period, approximately 6 weeks on average ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   26 Weeks to 40 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676844

Contacts
Contact: Helen Mactier, MB ChB 011441412115249 Helen.Mactier@ggc.scot.nhs.uk
Contact: Stewart I Watts, MPharm 011441415483577 stewart.watts@strath.ac.uk

Locations
United Kingdom
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         
Sponsors and Collaborators
University of Strathclyde
Investigators
Principal Investigator: Alex Mullen University of Strathclyde
  More Information

Publications:
Responsible Party: Professor Alex Mullen, Principal Investigator, University of Strathclyde
ClinicalTrials.gov Identifier: NCT01676844     History of Changes
Other Study ID Numbers: UEC1112/65, 2012-003625-19
Study First Received: August 23, 2012
Last Updated: August 30, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Strathclyde:
Phosphorus
Phosphate
Hypophosphataemia
Osteopenia
Prematurity

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Hypophosphatemia
Bone Diseases
Musculoskeletal Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Pharmaceutical Solutions
Potassium phosphate
Therapeutic Uses
Pharmacologic Actions
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014