Infant-parent Skin-to-skin Contact During Screening for Retinopathy
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|ClinicalTrials.gov Identifier: NCT02780544|
Recruitment Status : Completed
First Posted : May 23, 2016
Last Update Posted : January 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Retinopathy of Prematurity||Behavioral: skin-to-skin contact Device: incubator Drug: Sucrose||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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?|
|Actual Study Start Date :||January 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
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.
Behavioral: skin-to-skin contact
skin-to-skin contact with parent during eye examination.
oral sucrose before eye examination
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
staying in incubator during eye examination.
oral sucrose before eye examination
- 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)
- cortisol in saliva [ Time Frame: 60 minutes after eye examination ]to measure stress response
- General movements [ Time Frame: in 5 minutes after eye examination ]Prechtl method on the General Movements Assessment (GMA) and classified according to the general movements optimality list for preterm general movements and writing movements
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780544
|St.Olavs University Hospital|
|Trondheim, Trondelag, Norway, 7006|
|Principal Investigator:||Hakon Bergseng, PhD||St.Olavs University Hospital|