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

January 3, 2019 updated by: St. Olavs Hospital

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?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Trondelag
      • Trondheim, Trondelag, Norway, 7006
        • St.Olavs university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Infants with ongoing analgesic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Sucrose
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
Drug: Sucrose
oral sucrose before eye examination
Device: incubator
staying in incubator during eye examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
during eye examination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cortisol in saliva
Time Frame: 60 minutes after eye examination
to measure stress response
60 minutes after eye examination
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
in 5 minutes after eye examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

Investigators

  • Principal Investigator: Hakon Bergseng, PhD, St.Olavs university hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 23, 2016

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/2532b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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