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

Not Applicable

Completed

• Conditions: Retinopathy of Prematurity
• Interventions: Behavioral: skin-to-skin contact; Device: incubator; Drug: Sucrose

• Registration Number: NCT02780544
• Lead Sponsor: St. Olavs Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-23
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-03
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Infants < 32 weeks of gestational age (< 31+6 weeks)

Exclusion Criteria

• Infants with ongoing analgesic treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
skin-to-skin contact + sucrose	skin-to-skin contact	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	incubator	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
skin-to-skin contact + sucrose	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.
incubator + sucrose	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

Primary Outcome Measures

Name	Time	Method
pain score	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)

Secondary Outcome Measures

Name	Time	Method
cortisol in saliva	60 minutes after eye examination	to measure stress response
General movements	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

Trial Locations

Locations (1)

St.Olavs University Hospital; 🇳🇴 Trondheim, Trondelag, Norway