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

St. Olavs Hospital

Status: Completed

Conditions: Retinopathy of Prematurity

Treatments: Behavioral: skin-to-skin contact; Device: incubator; Drug: Sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT02780544

2011/2532b

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 31 to 37 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Infants with ongoing analgesic treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups

skin-to-skin contact + sucrose

Experimental group

Description:

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.

Treatment:

Drug: Sucrose

Behavioral: skin-to-skin contact

incubator + sucrose

Active Comparator group

Description:

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

Treatment:

Device: incubator

Drug: Sucrose