Trial · NCT01676844
Investigating a New Way of Giving Medicine to Newborn and Preterm Babies
NCT01676844, Phase 2, Unknown, University of Strathclyde
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Investigating a New Way of Giving Medicine to Newborn and Preterm Babies. Trials, record NCT01676844. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01676844
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Investigating a New Way of Giving Medicine to Newborn and Preterm Babies
- NCT number
- NCT01676844
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 20 participants, estimated
- Lead sponsor
- University of Strathclyde
- Conditions
- Hypophosphataemia, Osteopenia of Prematurity
- Interventions
- Oral thin film therapy (Potassium acid phosphate oral thin films), Standard therapy (Potassium acid phosphate oral solution)
- First posted
- 2012-08-31
- Last updated
- 2012-08-31
- Other registries' IDs
- eudract:2012-003625-19
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serum phosphate | 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. |
| Secondary | Age-appropriateness | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01676844
GET https://conductscience.org/api/trials/v1/NCT01676844/registered