- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02780544
Infant-parent Skin-to-skin Contact During Screening for Retinopathy
Is There a Difference in Pain Score, Stress Response and Motor Repertoire in Infants Given Skin-to-skin Contact With the Mother/Father or Standard Care During Screening for Retinopathy?
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.
In this study skin-to-skin contact with a parent is tested for relief of pain and stress in preterm infants being examined for retinopathy of prematurity.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Trondelag
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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: skin-to-skin contact + sucrose
the infants get 2 eye examinations within 1 week in randomized order, one in skin-to-skin position with a parent (intervention group) and one in the incubator (standard care).
Sucrose (0.2 ml) lingual will be given for pain relief according to standard care two minutes before either eye examination.
|
skin-to-skin contact with parent during eye examination.
oral sucrose before eye examination
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Active Comparator: incubator + sucrose
the infants get 2 eye examinations within 1 week in randomized order, one in the incubator (standard care) and one in skin-to-skin position with a parent (intervention group).
Sucrose (0.2 ml) lingual will be given for pain relief according to standard care two minutes before either eye examination
|
oral sucrose before eye examination
staying in incubator during eye examination.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain score
Time Frame: during eye examination
|
Premature Infant Pain Profile (PIPP): score range 0-21.
Assessed during and immediately after completed examination).
PIPP scoring via video recording by an external observer (blinded)
|
during eye examination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cortisol in saliva
Time Frame: 60 minutes after eye examination
|
to measure stress response
|
60 minutes after eye examination
|
General movements
Time Frame: in 5 minutes after eye examination
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Prechtl method on the General Movements Assessment (GMA) and classified according to the general movements optimality list for preterm general movements and writing movements
|
in 5 minutes after eye examination
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hakon Bergseng, PhD, St.Olavs University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/2532b
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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