Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Universiteit Antwerpen.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Universiteit Antwerpen
Information provided by:
Universiteit Antwerpen
ClinicalTrials.gov Identifier:
NCT00847028
First received: February 17, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | February 17, 2009 | ||||
| Last Updated Date | February 17, 2009 | ||||
| Start Date ICMJE | November 2007 | ||||
| Estimated Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pain after venipuncture measured by the Leuven pain scale for newborns [ Time Frame: solution administration- waiting for 2 minutes-then venipuncture and immediate pain scoring ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
difference in heart rhythm [ Time Frame: heart rhythm measured before painful procedure - heart rythm after venipuncture compared to baseline measurement ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial | ||||
| Official Title ICMJE | Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial | ||||
| Brief Summary | This study investigates which concentration of glucose is most effective in reducing pain for venipuncture in the newborn. |
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| Detailed Description | This double-blind clinical trial is conducted on a maternity and newborn (N*) ward. Each time, during at least one month, one of the four selected solutions (glucose 10%, 20%, 30% and placebo) will be administered orally, 2 minutes prior to the venipuncture. The pain from the skin puncture will be scored using a validated pain scale (the "Leuven" pain scale). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
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| Condition ICMJE | Pain | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 304 | ||||
| Estimated Completion Date | April 2009 | ||||
| Estimated Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria
Exclusion criteria
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Belgium | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00847028 | ||||
| Other Study ID Numbers ICMJE | HHmol-001, (EC NR 7/37/203). | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Prof. Monique M. Elseviers, Nusing Sciences, University of Antwerp | ||||
| Study Sponsor ICMJE | Universiteit Antwerpen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Universiteit Antwerpen | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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