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

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ClinicalTrials.gov Identifier: NCT02780544
Recruitment Status : Completed
First Posted : May 23, 2016
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Behavioral: skin-to-skin contact Device: incubator Drug: Sucrose Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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?
Actual Study Start Date : January 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

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
Device: incubator
staying in incubator during eye examination.

Drug: Sucrose
oral sucrose before eye examination




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. cortisol in saliva [ Time Frame: 60 minutes after eye examination ]
    to measure stress response

  2. 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



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Ages Eligible for Study:   31 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Infants with ongoing analgesic treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780544


Locations
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Norway
St.Olavs University Hospital
Trondheim, Trondelag, Norway, 7006
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
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Principal Investigator: Hakon Bergseng, PhD St.Olavs University Hospital

Publications of Results:
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT02780544     History of Changes
Other Study ID Numbers: 2011/2532b
First Posted: May 23, 2016    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by St. Olavs Hospital:
Infant, premature
Pain
Stress, physiological
Stress, psychological
skin-to-skin contact

Additional relevant MeSH terms:
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Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases