Back to resultsSkin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation
Primary Purpose
Premature Birth
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
skin-to-skin
standard care
Sponsored by
About this trial
This is an interventional treatment trial for Premature Birth focused on measuring Kangaroo-Mother Care Method, Stress, Physiological
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
Sites / Locations
- IWK Health Centre
- Nyfødt intensiv, Drammen sykehus
- Nyfødt intensiv, Sørlandet Sykehus
- NICU St Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
skin-to-skin
standard care
Arm Description
immediately after birth the baby is laid on mother's chest for as long as justifiable medically to max 2 hours.
after birth the baby is transferred to the neonatal intensive care unit
Outcomes
Primary Outcome Measures
cognitive scorer at two years corrected age
measured by Bayley Scales of Infant Development Third Edition (BSID III)
Secondary Outcome Measures
change in heart rate
change in body temperature
change in respiration frequency
change in blood glucose
general movements (GM) at 3 months corrected age
assessed with the General Movement Assessment (GMA)
Nutrition
based on a Norwegian questionnaire, based on a Norwegian national survey from The Norwegian Directorate of Health.
Social/emotional competence at three months corrected age
measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)
Social/emotional competence at two years corrected age
measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)
Social/emotional competence at two years corrected age
measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)
Developmental skills at two years corrected age
measured with the Ages and Stages Questionnaire: (ASQ)
Developmental skills at two years corrected age
measured with the Ages and Stages Questionnaire: (ASQ)
Maternal anxiety
measured with State-Trait Anxiety Inventory (STAI)
Maternal anxiety
measured with State-Trait Anxiety Inventory (STAI)
Maternal anxiety
measured with State-Trait Anxiety Inventory (STAI)
Child Behaviour
Measured with Child Behaviour Checklist
Full Information
NCT ID
NCT02024854
First Posted
December 19, 2013
Last Updated
January 19, 2023
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Drammen sykehus, Sorlandet Hospital HF, IWK Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT02024854
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2014 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Drammen sykehus, Sorlandet Hospital HF, IWK Health Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
Kangaroo-Mother Care Method, Stress, Physiological
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
skin-to-skin
Arm Type
Experimental
Arm Description
immediately after birth the baby is laid on mother's chest for as long as justifiable medically to max 2 hours.
Arm Title
standard care
Arm Type
Active Comparator
Arm Description
after birth the baby is transferred to the neonatal intensive care unit
Intervention Type
Behavioral
Intervention Name(s)
skin-to-skin
Intervention Type
Behavioral
Intervention Name(s)
standard care
Primary Outcome Measure Information:
Title
cognitive scorer at two years corrected age
Description
measured by Bayley Scales of Infant Development Third Edition (BSID III)
Time Frame
2 year
Secondary Outcome Measure Information:
Title
change in heart rate
Time Frame
24 hours
Title
change in body temperature
Time Frame
24 hours
Title
change in respiration frequency
Time Frame
24 hours
Title
change in blood glucose
Time Frame
24 hours
Title
general movements (GM) at 3 months corrected age
Description
assessed with the General Movement Assessment (GMA)
Time Frame
3 months
Title
Nutrition
Description
based on a Norwegian questionnaire, based on a Norwegian national survey from The Norwegian Directorate of Health.
Time Frame
1 year
Title
Social/emotional competence at three months corrected age
Description
measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)
Time Frame
3 months
Title
Social/emotional competence at two years corrected age
Description
measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)
Time Frame
1 year
Title
Social/emotional competence at two years corrected age
Description
measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)
Time Frame
2 years
Title
Developmental skills at two years corrected age
Description
measured with the Ages and Stages Questionnaire: (ASQ)
Time Frame
1 year
Title
Developmental skills at two years corrected age
Description
measured with the Ages and Stages Questionnaire: (ASQ)
Time Frame
2 years
Title
Maternal anxiety
Description
measured with State-Trait Anxiety Inventory (STAI)
Time Frame
at discharge from hospital
Title
Maternal anxiety
Description
measured with State-Trait Anxiety Inventory (STAI)
Time Frame
3 months
Title
Maternal anxiety
Description
measured with State-Trait Anxiety Inventory (STAI)
Time Frame
2 years
Title
Child Behaviour
Description
Measured with Child Behaviour Checklist
Time Frame
5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Håkon Bergseng, md phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
Country
Canada
Facility Name
Nyfødt intensiv, Drammen sykehus
City
Drammen
Country
Norway
Facility Name
Nyfødt intensiv, Sørlandet Sykehus
City
Kristiansand
Country
Norway
Facility Name
NICU St Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
27955652
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.
Results Reference
background
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Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation
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