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OpenTrials
Completed

NCT Number: NCT02780544

Infant-parent Skin-to-skin Contact 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.

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Key information

Conditions

Retinopathy of Prematurity Behavior Behavioral Symptoms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Neurologic Manifestations Obstetric Labor Complications Obstetric Labor, Premature Pain Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Retinal Diseases Signs and Symptoms Stress, Psychological Urogenital Diseases

Age range

31 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St.Olavs University Hospital

Trondheim, Trøndelag, 7006, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Infants with ongoing analgesic treatment

Treatment and study plan

Skin-to-Skin contact

Behavioral

skin-to-skin contact with parent during eye examination.

incubator

Device

staying in incubator during eye examination.

Sucrose

Drug

oral sucrose before eye examination

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study 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?

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 23, 2016
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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