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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| skin-to-skin contact + sucrose | Experimental | 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. |
|
| incubator + sucrose | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| skin-to-skin contact | Behavioral | skin-to-skin contact with parent during eye examination. |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain score | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| cortisol in saliva | to measure stress response | 60 minutes after eye examination |
| General movements | Prechtl method on the General Movements Assessment (GMA) and classified according to the general movements optimality list for preterm general movements and writing movements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hakon Bergseng, PhD | St. Olavs Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Olavs University Hospital | Trondheim | Trøndelag | 7006 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30561825 | Result | Kristoffersen L, Stoen R, Bergseng H, Follestad T, Theodorsson E, Vederhus B, Adde L, Austeng D. Skin-to-skin contact during eye examination did not reduce pain compared to standard care with parental support in preterm infants. Acta Paediatr. 2019 Aug;108(8):1434-1440. doi: 10.1111/apa.14699. Epub 2019 Jan 18. |
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| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| D047928 | Premature Birth |
| D010146 | Pain |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D007185 | Incubators |
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
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| incubator | Device | staying in incubator during eye examination. |
|
| Sucrose | Drug | oral sucrose before eye examination |
|
| in 5 minutes after eye examination |
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D002241 |
| Carbohydrates |
| D000073893 | Sugars |