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

Retinopathy of Prematurity Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780544
• Other study ID #: 2011/2532b
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2019
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Weeks to 37 Weeks

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Infants with ongoing analgesic treatment

Related Conditions & MeSH terms

• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Behavioral:
• skin-to-skin contact
skin-to-skin contact with parent during eye examination.

Device:
• incubator
staying in incubator during eye examination.

Drug:
• Sucrose
oral sucrose before eye examination

Locations

Country	Name	City	State
Norway	St.Olavs University Hospital	Trondheim	Trondelag

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Kristoffersen L, Støen 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. 2018 Dec 18 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	during eye examination
Secondary	cortisol in saliva	to measure stress response	60 minutes after eye examination
Secondary	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	in 5 minutes after eye examination