- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01552993
Registration and Treatment of Pain During Eye Examination of Prematurity
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Trondelag
-
Trondheim, Trondelag, Norway, 7006
- St.Olavs University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Infants < 32 weeks of gestational age (< 31+6 weeks)
Exclusion Criteria:
- Infants with ongoing analgesic treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: paracetamol
Paracetamol mixture 20 mg/kg + pacifier and sucrose
|
Paracetamol mixture 20 mg/kg + pacifier and glucose
|
Placebo Comparator: placebo
pacifier and sucrose only
|
pacifier and sucrose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain
Time Frame: 5 minutes
|
Premature Infant Pain Profile (PIPP): score range 0-21.
Used independently by 2 experienced observers
|
5 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hakon Bergseng, PhD, St.Olavs University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HB2012-02
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