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

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?

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02780544

Enrollment

Registered

2016-05-23

Start date

2014-01-31

Completion date

2016-06-30

Last updated

2019-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of Prematurity

Keywords

Infant, premature, Pain, Stress, physiological, Stress, psychological, skin-to-skin contact

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.

Interventions

BEHAVIORALskin-to-skin contact

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

DEVICEincubator

staying in incubator during eye examination.

DRUGSucrose

oral sucrose before eye examination

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

31 Weeks to 37 Weeks

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Infants with ongoing analgesic treatment

Design outcomes

Primary

Measure	Time frame	Description
pain score	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

Measure	Time frame	Description
cortisol in saliva	60 minutes after eye examination	to measure stress response
General movements	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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026