Infant-parent Skin-to-skin Contact During Screening for Retinopathy

Study Overview
=================
Brief Summary
-----------------
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.

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?

Conditions
-----------------
Retinopathy of Prematurity

Intervention / Treatment
-----------------
* Behavioral: skin-to-skin contact
* Device: incubator
* Drug: Sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants < 32 weeks of gestational age (< 31+6 weeks) Exclusion Criteria: Infants with ongoing analgesic treatment

Ages Eligible for Study
-----------------
Minimum Age: 31 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: skin-to-skin contact + sucrose<br>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<br>* skin-to-skin contact with parent during eye examination.<br>Drug: Sucrose<br>* oral sucrose before eye examination<br>|
| Active Comparator: incubator + sucrose<br>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 | Device: incubator<br>* staying in incubator during eye examination.<br>Drug: Sucrose<br>* oral sucrose before eye examination<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | in 5 minutes after eye examination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infant, premature, Pain, Stress, physiological, Stress, psychological, skin-to-skin contact