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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
91
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.
Neonates will get Conventional care the first 72 hours after birth
Stavanger University Hospital
Stavanger, Norway
Department of Women´s and Children´s Health, Karolinska University Hospital
Stockholm, Sweden
Cardiorespiratory stability
Using the Stability of the CardioRespiratory system In the Preterm-score (SCRIP-score). A higher SCRIP score indicates greater physiological stability
Time frame: After six hours
Need for respiratory support
Days in respirator from birth to discharge from hospital
Time frame: After 3 months
Need for surfactant
Number of doses of surfactants from birth to discharge from hospital,
Time frame: After 3 months
Need of Continuous positive airway pressure
Days in use of Continuous positive airway pressure (CPAP)- from birth to discharge from hospital
Time frame: After 3 months
Need for oxygen
Days in use of oxygen from birth to discharge from hospital
Time frame: After 3 months
Heart Rate Variability
Time frame: Up to 3-4 months
Body temperature
Axillary body temperature
Time frame: At 0 hour (postpartum), 1, 2, 3, 4, 5 and 6 hours
Sepsis episodes
Number of Sepsis episodes from birth to discharge from hospital, based on the Medical records
Time frame: After 3 months
Number of Antibiotic treatment
Number of Days with antibiotic treatment from birth to discharge from hospital based on Medical records
Time frame: After 3 months
Status of Breast-feeding
Status of Breast-feeding according to a specific questionnaire: Index of Breastfeeding (IBS)
Time frame: Up to12 months
Status of Breast-feeding
Status of Breast-feeding according to a specific questionnaire: Breastfeeding Self efficacy Questionnaire (BSES)
Time frame: Up to12 months
Status of Breast-feeding
Status of Breast-feeding according to a specific questionnaire: Infant Breastfeeding Assessment Tool (IBFAT).
Time frame: Up to12 months
Time to Full enteral nutrition
Days from birth until Full enteral nutrition
Time frame: After 3 months
Time in use of Nasogastric tube feeding
Days from birth in use of Nasogastric tube feeding
Time frame: After 3 months
Time to recovered birth weight
Days from birth until recovered birth weight
Time frame: After 3 months
Weight gain
Weight gain from birth
Time frame: Up to 12 months
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.
Time frame: Up to 24 months
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.
Time frame: Up to 24 months
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.
Time frame: Up to 24 months
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
Time frame: Up to 24 months
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.
Time frame: 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.
Maturation of EEG-pattern
Time frame: Postnatal day 4-10 and postmenstrual age of 40-42 weeks
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.
Time frame: At term age
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.
Time frame: At 4 months
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)
Time frame: At 3-4 months and at 12 and 24 months.
Bonding and interaction between parent and child
A videotaped mother-infant interaction session will be assessed through the "Still Face situation"
Time frame: At 3-4 months
Parents' experiences
Parents will fill in the following questionnaire: State-Trait Anxiety Index(STAI)
Time frame: Up to 12 months
Parents' experiences
Parents will fill in the following questionnaire: Swedish Parenting Questionnaire (SPSQ)
Time frame: Up to 12 months
Parents' experiences
Parents will fill in the following questionnaire: Edinburgh postnatal Depression Scale (EPDS)
Time frame: Up to 12 months
Maternal-Child physiological attunement in stress regulation
Saliva Cortisol both mother and child
Time frame: 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.
Neuro Behaviour of Child
According to records and to questionnaires for example Infant Behavior Questionnaire (IBQ)
Time frame: At term age, at 3-4, 12 and 24 months
Neuro Behaviour of Child
According to records and to questionnaires for example Bayley Scales
Time frame: At term age, at 3-4, 12 and 24 months
Neuro Behaviour of Child
According to records and to questionnaires for example Ages and Stages Questionnaire (ASQ)
Time frame: At term age, at 3-4, 12 and 24 months
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