Clinical trial NCT02024854: Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation
Official title: Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Premature Birth
Keywords: Kangaroo-Mother Care Method
Stress, Physiological
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Drammen sykehus
name: Sorlandet Hospital HF
name: IWK Health Centre
First posted: 2013-12-31
Enrollment: 108
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate physiological response, social/emotional response and general movements in preterm infants when they are given skin-to-skin contact with the mother (intervention) or standard care (incubator) right after delivery. Preterm infants will be randomized to either intervention or standard care group. Data on body temperature, blood glucose, hart rate, respiration rate and oxygen saturation will be obtained. In addition the infant will be video-recorded during the first 24 hours and at three months of age for analysis of the general movements.

Detailed description: Power calculations are based on a difference in Bayley Scale of Infant Development III, cognitive scale at two years corrected age of about 7,5 mean score =0.5 SD (α=0,05, β=0.80). Based on this analysis, 64 preterm infants are needed in each group to yield statistic significance. Allowing for withdrawals, the sample size is set to 68 in each group.

Eligibility criteria: Inclusion Criteria:

* Preterm infants at 28-32 weeks of gestation (born 12-8 weeks before term)

Exclusion Criteria:

* Infants who need immediate medical interventions

Primary outcomes:
measure: cognitive scorer at two years corrected age
timeFrame: 2 year
Secondary outcomes:
measure: change in heart rate
timeFrame: 24 hours
measure: change in body temperature
timeFrame: 24 hours
measure: change in respiration frequency
timeFrame: 24 hours
measure: change in blood glucose
timeFrame: 24 hours
measure: general movements (GM) at 3 months corrected age
timeFrame: 3 months
measure: Nutrition
timeFrame: 1 year
measure: Social/emotional competence at three months corrected age
timeFrame: 3 months
measure: Social/emotional competence at two years corrected age
timeFrame: 1 year
measure: Social/emotional competence at two years corrected age
timeFrame: 2 years
measure: Developmental skills at two years corrected age
timeFrame: 1 year
measure: Developmental skills at two years corrected age
timeFrame: 2 years
measure: Maternal anxiety
timeFrame: at discharge from hospital
measure: Maternal anxiety
timeFrame: 3 months
measure: Maternal anxiety
timeFrame: 2 years
measure: Child Behaviour
timeFrame: 5 year
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
city: Drammen
country: Norway
facility: Nyfødt intensiv, Drammen sykehus
city: Kristiansand
country: Norway
facility: Nyfødt intensiv, Sørlandet Sykehus
city: Trondheim
country: Norway
facility: NICU St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Håkon Bergseng, md phd
role: STUDY_DIRECTOR
References:
citation: Kristoffersen L, Stoen R, Rygh H, Sognnaes M, Follestad T, Mohn HS, Nissen I, Bergseng H. Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial. Trials. 2016 Dec 12;17(1):593. doi: 10.1186/s13063-016-1730-5.