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

Primary Purpose

Retinopathy of Prematurity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
skin-to-skin contact
incubator
Sucrose
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinopathy of Prematurity focused on measuring Infant, premature, Pain, Stress, physiological, Stress, psychological, skin-to-skin contact

Eligibility Criteria

31 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Infants with ongoing analgesic treatment

Sites / Locations

  • St.Olavs University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

skin-to-skin contact + sucrose

incubator + sucrose

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

cortisol in saliva
to measure stress response
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

Full Information

First Posted
May 12, 2016
Last Updated
January 3, 2019
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02780544
Brief Title
Infant-parent Skin-to-skin Contact During Screening for Retinopathy
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?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity
Keywords
Infant, premature, Pain, Stress, physiological, Stress, psychological, skin-to-skin contact

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
skin-to-skin contact + sucrose
Arm Type
Experimental
Arm Description
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.
Arm Title
incubator + sucrose
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
skin-to-skin contact
Intervention Description
skin-to-skin contact with parent during eye examination.
Intervention Type
Device
Intervention Name(s)
incubator
Intervention Description
staying in incubator during eye examination.
Intervention Type
Drug
Intervention Name(s)
Sucrose
Intervention Description
oral sucrose before eye examination
Primary Outcome Measure Information:
Title
pain score
Description
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)
Time Frame
during eye examination
Secondary Outcome Measure Information:
Title
cortisol in saliva
Description
to measure stress response
Time Frame
60 minutes after eye examination
Title
General movements
Description
Prechtl method on the General Movements Assessment (GMA) and classified according to the general movements optimality list for preterm general movements and writing movements
Time Frame
in 5 minutes after eye examination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
31 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants < 32 weeks of gestational age (< 31+6 weeks) Exclusion Criteria: Infants with ongoing analgesic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakon Bergseng, PhD
Organizational Affiliation
St.Olavs University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St.Olavs University Hospital
City
Trondheim
State/Province
Trondelag
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30561825
Citation
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.
Results Reference
result

Learn more about this trial

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

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