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

NCT02780544 | Completed

• 1 other identifier: 2011/2532b
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinopathy of Prematurity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• cortisol in saliva

  60 minutes after eye examination

• General movements

  in 5 minutes after eye examination

Study Arms (2)

skin-to-skin contact + sucrose

EXPERIMENTAL

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; Drug: Sucrose

incubator + sucrose

ACTIVE COMPARATOR

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; Drug: Sucrose

Interventions

skin-to-skin contact BEHAVIORAL

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

skin-to-skin contact + sucrose

incubator DEVICE

staying in incubator during eye examination.

incubator + sucrose

Sucrose DRUG

oral sucrose before eye examination

incubator + sucrose; skin-to-skin contact + sucrose

Eligibility Criteria

• Age: 31 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Infants with ongoing analgesic treatment

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St.Olavs University Hospital

Trondheim, Trøndelag, 7006, Norway

Location

Related Publications (1)

• Kristoffersen L, Stoen 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. 2019 Aug;108(8):1434-1440. doi: 10.1111/apa.14699. Epub 2019 Jan 18.

  PMID: 30561825 RESULT

MeSH Terms

Conditions

Retinopathy of Prematurity; Premature Birth; Pain; Stress, Psychological

Interventions

Incubators; Sucrose

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Hakon Bergseng, PhD

  St. Olavs University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 23, 2016
• Study Start: January 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 4, 2019

Record last verified: 2019-01

Locations

NO (1)