Premature BirthNCT02024854
Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation
A study testing skin-to-skin in people with Premature Birth, run by Norwegian University of Science and Technology at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 to 32 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- skin-to-skin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Feb 2014to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants at 28-32 weeks of gestation (born 12-8 weeks before term)
Who cannot join
- Infants who need immediate medical interventions
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Norway3 sites
Nyfødt intensiv, Drammen sykehus
Drammen
Nyfødt intensiv, Sørlandet Sykehus
Kristiansand
NICU St Olavs Hospital
Trondheim
About this study
Official title: Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation. A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Premature Birth
- Being tested
- skin-to-skin, standard care
- Keywords
- Kangaroo-Mother Care Method, Stress, Physiological
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin-to-skinBehavioural
standard careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| skin-to-skin | Experimental | immediately after birth the baby is laid on mother's chest for as long as justifiable medically to max 2 hours. Receives: Behavioral: skin-to-skin |
| standard care | Active comparator | after birth the baby is transferred to the neonatal intensive care unit Receives: Behavioral: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive scorer at two years corrected age
measured by Bayley Scales of Infant Development Third Edition (BSID III)
Measured: 2 year
Secondary outcomes (15)
change in heart rate
Measured: 24 hours
change in body temperature
Measured: 24 hours
change in respiration frequency
Measured: 24 hours
change in blood glucose
Measured: 24 hours
general movements (GM) at 3 months corrected age
assessed with the General Movement Assessment (GMA)
Measured: 3 months
Nutrition
based on a Norwegian questionnaire, based on a Norwegian national survey from The Norwegian Directorate of Health.
Measured: 1 year
Social/emotional competence at three months corrected age
measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)
Measured: 3 months
Social/emotional competence at two years corrected age
measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)
Measured: 1 year
Social/emotional competence at two years corrected age
measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)
Measured: 2 years
Developmental skills at two years corrected age
measured with the Ages and Stages Questionnaire: (ASQ)
Measured: 1 year
Developmental skills at two years corrected age
measured with the Ages and Stages Questionnaire: (ASQ)
Measured: 2 years
Maternal anxiety
measured with State-Trait Anxiety Inventory (STAI)
Measured: at discharge from hospital
Maternal anxiety
measured with State-Trait Anxiety Inventory (STAI)
Measured: 3 months
Maternal anxiety
measured with State-Trait Anxiety Inventory (STAI)
Measured: 2 years
Child Behaviour
Measured with Child Behaviour Checklist
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study start1 Feb 2014
- Primary completion31 Dec 2022
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Drammen sykehus, Sorlandet Hospital HF, IWK Health Centre
- Responsible party
- Sponsor
- Investigators
- Håkon Bergseng, md phd, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024854
- Sponsor's protocol ID
- KC28-32
- Status last verified
- Jun 2025
- First submitted
- 19 Dec 2013
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27955652Kristoffersen L, Stoen R, Bergseng H, Flottorp ST, Mageroy G, Grunewaldt KH, Aker K. Immediate Skin-to-Skin Contact in Very Preterm Neonates and Early Childhood Neurodevelopment: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e255467. doi: 10.1001/jamanetworkopen.2025.5467.
PubMed 40238094Kristoffersen L, Bergseng H, Engesland H, Bagstevold A, Aker K, Stoen R. Skin-to-skin contact in the delivery room for very preterm infants: a randomised clinical trial. BMJ Paediatr Open. 2023 Mar;7(1):e001831. doi: 10.1136/bmjpo-2022-001831.
PubMed 36958792
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02024854
- Acronym / sponsor ID
- KC28-32
- Conditions
- Premature Birth
- Keywords
- Kangaroo-Mother Care Method, Stress, Physiological
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Drammen sykehus, Sorlandet Hospital HF, IWK Health Centre
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| skin-to-skin | Experimental | Behavioral: skin-to-skinimmediately after birth the baby is laid on mother's chest for as long as justifiable medically to max 2 hours. |
| standard care | Active comparator | Behavioral: standard careafter birth the baby is transferred to the neonatal intensive care unit |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants at 28-32 weeks of gestation (born 12-8 weeks before term)
Key exclusion criteria (1 listed)
- Infants who need immediate medical interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin-to-skin | Behavioural | skin-to-skin |
| standard care | Behavioural | standard care |
Primary outcome
cognitive scorer at two years corrected age
Time frame: 2 year
measured by Bayley Scales of Infant Development Third Edition (BSID III)
15 secondary outcomes
change in heart rate
Time frame: 24 hours
change in body temperature
Time frame: 24 hours
change in respiration frequency
Time frame: 24 hours
change in blood glucose
Time frame: 24 hours
general movements (GM) at 3 months corrected age
Time frame: 3 months
Nutrition
Time frame: 1 year
Social/emotional competence at three months corrected age
Time frame: 3 months
Social/emotional competence at two years corrected age
Time frame: 1 year
Social/emotional competence at two years corrected age
Time frame: 2 years
Developmental skills at two years corrected age
Time frame: 1 year
Developmental skills at two years corrected age
Time frame: 2 years
Maternal anxiety
Time frame: at discharge from hospital
Maternal anxiety
Time frame: 3 months
Maternal anxiety
Time frame: 2 years
Child Behaviour
Time frame: 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Background: PubMed 27955652Kristoffersen 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.
- Derived from this study: PubMed 40238094Kristoffersen L, Stoen R, Bergseng H, Flottorp ST, Mageroy G, Grunewaldt KH, Aker K. Immediate Skin-to-Skin Contact in Very Preterm Neonates and Early Childhood Neurodevelopment: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e255467. doi: 10.1001/jamanetworkopen.2025.5467.
- Derived from this study: PubMed 36958792Kristoffersen L, Bergseng H, Engesland H, Bagstevold A, Aker K, Stoen R. Skin-to-skin contact in the delivery room for very preterm infants: a randomised clinical trial. BMJ Paediatr Open. 2023 Mar;7(1):e001831. doi: 10.1136/bmjpo-2022-001831.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Håkon Bergseng, md phd study director
Norwegian University of Science and Technology
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin-to-skin in people with Premature Birth, run by Norwegian University of Science and Technology at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive scorer at two years corrected age (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02024854, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.