Registration and Treatment of Pain During Eye Examination of Prematurity
This study is currently recruiting participants.
Verified April 2013 by St. Olavs Hospital
Sponsor:
St. Olavs Hospital
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01552993
First received: March 2, 2012
Last updated: April 11, 2013
Last verified: April 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 2, 2012 | ||||||||
| Last Updated Date | April 11, 2013 | ||||||||
| Start Date ICMJE | March 2012 | ||||||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
pain [ Time Frame: 5 minutes ] [ Designated as safety issue: No ] Premature Infant Pain Profile (PIPP): score range 0-21. Used independently by 2 experienced observers |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01552993 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Registration and Treatment of Pain During Eye Examination of Prematurity | ||||||||
| Official Title ICMJE | Registration and Treatment of Pain During Eye Examination of Prematurity | ||||||||
| Brief Summary | The aim of this study is to see if paracetamol has a pain-relieving effect during eye examination in premature infants. |
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| Detailed Description | Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered in time, the disease can be treated, and impaired vision or blindness can be reduced. Premature infants are therefore examined regularly after birth. However, the examination is painful and stressful for the infant. Painful experiences might lead to a pathological stress response later in life and should therefore be prevented. This is a double blinded, controlled and randomized study where the infants are examined and assessed either with or without the use of paracetamol. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 70 | ||||||||
| Estimated Completion Date | December 2015 | ||||||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 31 Weeks to 37 Weeks | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Norway | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01552993 | ||||||||
| Other Study ID Numbers ICMJE | HB2012-02 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | St. Olavs Hospital | ||||||||
| Study Sponsor ICMJE | St. Olavs Hospital | ||||||||
| Collaborators ICMJE | Norwegian University of Science and Technology | ||||||||
| Investigators ICMJE |
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| Information Provided By | St. Olavs Hospital | ||||||||
| Verification Date | April 2013 | ||||||||
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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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