Immediate Parent -Infant Skin-to-Skin Study (IPISTOSS)
- Conditions
- Prematurity
- Interventions
- Procedure: Skin-to-skinProcedure: Conventional care
- Registration Number
- NCT03521310
- Lead Sponsor
- Björn Westrup, MD PhD
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 91
- 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.
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Born outside the hospital
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Triplets or more
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Known malformation which will require immediate surgical action
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On-going resuscitation or intensive Medical care (mechanic ventilation or inotropy) after the first lifespan
* Known congenital infection
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Parent/care giver can not communicate in Swedish/Norwegian or English
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Not suited for the study for other reasons (according to the principal investigator)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Skin-to-skin Contact group Skin-to-skin Neonates 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. Conventional care group Conventional care Neonates in gestational age between 28+0 - 32+6 will get Conventional care - incubators, warmers etc - the first 72 hours after birth.
- Primary Outcome Measures
Name Time Method Cardiorespiratory stability After six hours Using the Stability of the CardioRespiratory system In the Preterm-score (SCRIP-score). A higher SCRIP score indicates greater physiological stability
- Secondary Outcome Measures
Name Time Method Need for respiratory support After 3 months Days in respirator from birth to discharge from hospital
Time to Full enteral nutrition After 3 months Days from birth until Full enteral nutrition
Need for surfactant After 3 months Number of doses of surfactants from birth to discharge from hospital,
Heart Rate Variability Up to 3-4 months Weight gain Up to 12 months Weight gain from birth
Need of Continuous positive airway pressure After 3 months Days in use of Continuous positive airway pressure (CPAP)- from birth to discharge from hospital
Need for oxygen After 3 months Days in use of oxygen from birth to discharge from hospital
Body temperature At 0 hour (postpartum), 1, 2, 3, 4, 5 and 6 hours Axillary body temperature
Sepsis episodes After 3 months Number of Sepsis episodes from birth to discharge from hospital, based on the Medical records
Status of Breast-feeding Up to12 months Status of Breast-feeding according to a specific questionnaire: Infant Breastfeeding Assessment Tool (IBFAT).
Telomere profiling in blood samples Up to 24 months Whole-genome methylation analysis and locus specific analysis of selected stress related genes, will be conducted to investigate telomere length
Microbiota 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. 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.
Structural and functional maturation of the infant brain At term age 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.
Parents' experiences Up to 12 months Parents will fill in the following questionnaire: Edinburgh postnatal Depression Scale (EPDS)
Number of Antibiotic treatment After 3 months Number of Days with antibiotic treatment from birth to discharge from hospital based on Medical records
Time in use of Nasogastric tube feeding After 3 months Days from birth in use of Nasogastric tube feeding
Epigenetic profiling in buccal cells Up to 24 months 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.
Telomere profiling in buccal cells Up to 24 months Whole-genome methylation analysis and locus specific analysis of selected stress related genes, will be conducted to investigate telomere length.
Time to recovered birth weight After 3 months Days from birth until recovered birth weight
Epigenetic profiling in blood samples Up to 24 months 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.
Maturation of EEG-pattern Postnatal day 4-10 and postmenstrual age of 40-42 weeks Maternal brain responsiveness At 4 months 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.
Bonding and interaction between parent and child At 3-4 months A videotaped mother-infant interaction session will be assessed through the "Still Face situation"
Maternal-Child physiological attunement in stress regulation 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. Saliva Cortisol both mother and child
Neuro Behaviour of Child At term age, at 3-4, 12 and 24 months According to records and to questionnaires for example Ages and Stages Questionnaire (ASQ)
Trial Locations
- Locations (2)
Stavanger University Hospital
🇳🇴Stavanger, Norway
Department of Women´s and Children´s Health, Karolinska University Hospital
🇸🇪Stockholm, Sweden