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PrematurityNCT03521310

Immediate Parent -Infant Skin-to-Skin Study (IPISTOSS)

A study testing Skin-to-skin and Conventional care in people with Prematurity, run by Björn Westrup, MD PhD at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The World Health Organization recommend all stable low birth weight neonates to have Skin-to-skin-Contact (SSC) after birth. Intermittent SSC is used in Sweden in neonatal units. Observations indicate that SSC makes neonates feel good. Read more about this study

Who is it for?
Any age
Conditions the study is for
Prematurity
What is being tested?
Skin-to-skin and Conventional care
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
2 sitesin 2 countries
Study dates
1 Apr 2018to 12 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Born in gestation week plus days 28+0 - 32+6.
  • Born at maternity ward at study center
  • Consent from parents/caregivers
  • Parent or caregiver or substitute are available to start skin-to-skin Contact during the first hour of life.

Who cannot join

  • Born outside the hospital
  • Triplets or more
  • Known malformation which will require immediate surgical action
  • On-going resuscitation or intensive Medical care (mechanic ventilation or inotropy) after the first lifespan
  • Known congenital infection
  • Parent/care giver can not communicate in Swedish/Norwegian or English
  • Not suited for the study for other reasons (according to the principal investigator)

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Norway1 site

  • Stavanger University Hospital

    Stavanger

Other trials in Norway

Sweden1 site

  • Department of Women´s and Children´s Health, Karolinska University Hospital

    Stockholm, SE 171 77

Other trials in Sweden

About this study

The World Health Organization recommend all stable low birth weight neonates to have Skin-to-skin-Contact (SSC) after birth. Intermittent SSC is used in Sweden in neonatal units. Observations indicate that SSC makes neonates feel good. However, there is limited research done on SSC treatment on neonates born prior to week 33.

The aim of this study is to investigate whether Skin-to-skin-Contact (SSC) leads to an improved physiological stabilization, altered epigenetic profile and improved longterm psychomotor outcome in neonates born in gestation age between week 28+0 - 32+6. This is a parallel, two-arm, multicentre, randomized controlled superiority trial. The two arms to be compared are a) immediate SSC with one parent/caregiver continous during the first 6 hours after birth and as much as possible during the first 72 hours, and b) conventional method of care during the same time.

Conditions
Prematurity
Being tested
Skin-to-skin, Conventional care
Keywords
IPISTOSS, Skin to skin, SSC, Neonatal, kangaroo mother care
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-skinProcedure or surgery

    Neonates will get Skin-to-skin Contact with parent/caregiver continuously the first 6 hours after birth and as much as possible the first 72 hours after birth.

  • Conventional careProcedure or surgery

    Neonates will get Conventional care the first 72 hours after birth

Study groups in NCT03521310
Study groupRoleWhat they receive
Skin-to-skin Contact groupExperimentalNeonates in gestational age between 28+0 - 32+6 will get continuous Skin-to-skin contact with one parent/caregiver the first 6 hours after birth and as much as possible the first 72 hours after birth.
Receives: Procedure: Skin-to-skin
Conventional care groupActive comparatorNeonates in gestational age between 28+0 - 32+6 will get Conventional care - incubators, warmers etc - the first 72 hours after birth.
Receives: Procedure: Conventional care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiorespiratory stability

    Using the Stability of the CardioRespiratory system In the Preterm-score (SCRIP-score). A higher SCRIP score indicates greater physiological stability

    Measured: After six hours

Secondary outcomes (32)

  1. Need for respiratory support

    Days in respirator from birth to discharge from hospital

    Measured: After 3 months

  2. Need for surfactant

    Number of doses of surfactants from birth to discharge from hospital,

    Measured: After 3 months

  3. Need of Continuous positive airway pressure

    Days in use of Continuous positive airway pressure (CPAP)- from birth to discharge from hospital

    Measured: After 3 months

  4. Need for oxygen

    Days in use of oxygen from birth to discharge from hospital

    Measured: After 3 months

  5. Heart Rate Variability

    Measured: Up to 3-4 months

  6. Body temperature

    Axillary body temperature

    Measured: At 0 hour (postpartum), 1, 2, 3, 4, 5 and 6 hours

  7. Sepsis episodes

    Number of Sepsis episodes from birth to discharge from hospital, based on the Medical records

    Measured: After 3 months

  8. Number of Antibiotic treatment

    Number of Days with antibiotic treatment from birth to discharge from hospital based on Medical records

    Measured: After 3 months

  9. Status of Breast-feeding

    Status of Breast-feeding according to a specific questionnaire: Index of Breastfeeding (IBS)

    Measured: Up to12 months

  10. Status of Breast-feeding

    Status of Breast-feeding according to a specific questionnaire: Breastfeeding Self efficacy Questionnaire (BSES)

    Measured: Up to12 months

  11. Status of Breast-feeding

    Status of Breast-feeding according to a specific questionnaire: Infant Breastfeeding Assessment Tool (IBFAT).

    Measured: Up to12 months

  12. Time to Full enteral nutrition

    Days from birth until Full enteral nutrition

    Measured: After 3 months

  13. Time in use of Nasogastric tube feeding

    Days from birth in use of Nasogastric tube feeding

    Measured: After 3 months

  14. Time to recovered birth weight

    Days from birth until recovered birth weight

    Measured: After 3 months

  15. Weight gain

    Weight gain from birth

    Measured: Up to 12 months

  16. Epigenetic profiling in buccal cells

    Whole-genome methylation analysis and locus specific analysis of selected stress related genes, will be conducted to investigate early, intermediate and long-term epigenetic changes due to the intervention.

    Measured: Up to 24 months

  17. Telomere profiling in buccal cells

    Whole-genome methylation analysis and locus specific analysis of selected stress related genes, will be conducted to investigate telomere length.

    Measured: Up to 24 months

  18. Epigenetic profiling in blood samples

    Whole-genome methylation analysis and locus specific analysis of selected stress related genes, will be conducted to investigate early, intermediate and long-term epigenetic changes due to the intervention.

    Measured: Up to 24 months

  19. Telomere profiling in blood samples

    Whole-genome methylation analysis and locus specific analysis of selected stress related genes, will be conducted to investigate telomere length

    Measured: Up to 24 months

  20. Microbiota

    The child's colonization with bacteria is identified by DNA-analysis from stool samples, nasal and skin swabs, compared with parents (mother is tested by vaginal, rectal, nasal and skin swabs.

    Measured: 0-6 hours, 72 hours, 3-4 months, 12 and 24 months. Mother is tested at 0-6 hours and partner with skin swabs at 0-6 hours.

  21. Maturation of EEG-pattern

    Measured: Postnatal day 4-10 and postmenstrual age of 40-42 weeks

  22. Structural and functional maturation of the infant brain

    Magnetic Resonance Imaging scans will be performed with a 3 Tesla machine. Three-dimensional and diffusion sequences as well as functional MRI (fMRI) sequences will be performed in order to examine structural and functional maturation respectively. Structural sequences are used to study the different tissues of the brain; diffusion images give information about the connections of the brain (white matter) and fMRI gives information on how the brain integrates information to perform a specific function.

    Measured: At term age

  23. Maternal brain responsiveness

    The maternal brain responses will be evaluated by using structural and functional magnetic resonance imaging to measure structural changes on social, emotional and behavioural networks as well as the cerebral response of mothers viewing neutral, happy and distress face images of their own infant, along with a matched unknown infant. We will use a 3 Tesla machine. We will study cortical and subcortical networks related with the emotional, social and behavioral responses involving the mother-child interactions and responses, such as the insula, the cingulate cortex, the precentral gyrus, the right orbital gyrus, the inferior, middle and superior frontal gyrus the fusiform gyrus, supramarginal gyrus, the superior parietal gyrus, the inferior temporal gyrus, and basal ganglia among others.

    Measured: At 4 months

  24. Bonding and interaction between parent and child

    A videotaped mother-infant interaction session will be assessed through with the Parent-Child Early Relational Assessment (PCERA)

    Measured: At 3-4 months and at 12 and 24 months.

  25. Bonding and interaction between parent and child

    A videotaped mother-infant interaction session will be assessed through the "Still Face situation"

    Measured: At 3-4 months

  26. Parents' experiences

    Parents will fill in the following questionnaire: State-Trait Anxiety Index(STAI)

    Measured: Up to 12 months

  27. Parents' experiences

    Parents will fill in the following questionnaire: Swedish Parenting Questionnaire (SPSQ)

    Measured: Up to 12 months

  28. Parents' experiences

    Parents will fill in the following questionnaire: Edinburgh postnatal Depression Scale (EPDS)

    Measured: Up to 12 months

  29. Maternal-Child physiological attunement in stress regulation

    Saliva Cortisol both mother and child

    Measured: In the morning and in the evening at the day of discharge, At the day of discharge before and after diaper change, at 3-4 months, at the same day as Still Face-test before and after, at 12 months.

  30. Neuro Behaviour of Child

    According to records and to questionnaires for example Infant Behavior Questionnaire (IBQ)

    Measured: At term age, at 3-4, 12 and 24 months

  31. Neuro Behaviour of Child

    According to records and to questionnaires for example Bayley Scales

    Measured: At term age, at 3-4, 12 and 24 months

  32. Neuro Behaviour of Child

    According to records and to questionnaires for example Ages and Stages Questionnaire (ASQ)

    Measured: At term age, at 3-4, 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2018
  2. Study start1 Apr 2018
  3. Primary completion12 Oct 2021
  4. Study completion12 Oct 2021

Why it stopped: Continued randomization was questioned on ethical grounds after the WHO iKMC study reported mortality reduction in May 2021. The DSMB recommended to stop the trial after reviewing a preliminary data analysis because of benefit of the intervention.

Resources

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
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03521310
Sponsor's protocol ID
IPISTOSS
Status last verified
Dec 2021
First submitted
20 Feb 2018
Last updated
6 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lillieskold S, Lode-Kolz K, Rettedal S, Lindstedt J, Linner A, Markhus Pike H, Ahlqvist-Bjorkroth S, Aden U, Jonas W. Skin-to-Skin Contact at Birth for Very Preterm Infants and Mother-Infant Interaction Quality at 4 Months: A Secondary Analysis of the IPISTOSS Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2344469. doi: 10.1001/jamanetworkopen.2023.44469.

    PubMed 38032643

  • Linner A, Westrup B, Lode-Kolz K, Klemming S, Lillieskold S, Markhus Pike H, Morgan B, Bergman NJ, Rettedal S, Jonas W. Immediate parent-infant skin-to-skin study (IPISTOSS): study protocol of a randomised controlled trial on very preterm infants cared for in skin-to-skin contact immediately after birth and potential physiological, epigenetic, psychological and neurodevelopmental consequences. BMJ Open. 2020 Jul 6;10(7):e038938. doi: 10.1136/bmjopen-2020-038938.

    PubMed 32636292

Questions about this trial

What is this clinical trial studying?

A study testing Skin-to-skin and Conventional care in people with Prematurity, run by Björn Westrup, MD PhD at 2 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway, Sweden. 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?

The study was stopped early (reason given: Continued randomization was questioned on ethical grounds after the WHO iKMC study reported mortality reduction in May 2021. The DSMB recommended to stop the trial after reviewing a preliminary data analysis because of benefit of the intervention.). Results are not available in the source record.

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?

Cardiorespiratory stability (time frame: After six hours). 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 NCT03521310, which also lists 2 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 6 Jan 2022.

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