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

Sponsor

Björn Westrup, MD PhD (Other)

Overall Status

Terminated

CT.gov ID

NCT03521310

Collaborator

University of Bergen (Other)

Enrollment

Locations

Arms

42.4

Actual Duration (Months)

45.5

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prematurity	Procedure: Skin-to-skin Procedure: Conventional care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

91 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2018

Actual Primary Completion Date :

Oct 12, 2021

Actual Study Completion Date :

Oct 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Skin-to-skin Contact group 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.	Procedure: Skin-to-skin 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.
Active Comparator: Conventional care group Neonates in gestational age between 28+0 - 32+6 will get Conventional care - incubators, warmers etc - the first 72 hours after birth.	Procedure: Conventional care Neonates will get Conventional care the first 72 hours after birth

Arm

Intervention/Treatment

Experimental: Skin-to-skin Contact group

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.

Procedure: Skin-to-skin

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.

Active Comparator: Conventional care group

Neonates in gestational age between 28+0 - 32+6 will get Conventional care - incubators, warmers etc - the first 72 hours after birth.

Procedure: Conventional care

Neonates will get Conventional care the first 72 hours after birth

Outcome Measures

Primary Outcome Measures

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

Need for respiratory support [After 3 months]
Days in respirator from birth to discharge from hospital
Need for surfactant [After 3 months]
Number of doses of surfactants from birth to discharge from hospital,
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
Heart Rate Variability [Up to 3-4 months]
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
Number of Antibiotic treatment [After 3 months]
Number of Days with antibiotic treatment from birth to discharge from hospital based on Medical records
Status of Breast-feeding [Up to12 months]
Status of Breast-feeding according to a specific questionnaire: Index of Breastfeeding (IBS)
Status of Breast-feeding [Up to12 months]
Status of Breast-feeding according to a specific questionnaire: Breastfeeding Self efficacy Questionnaire (BSES)
Status of Breast-feeding [Up to12 months]
Status of Breast-feeding according to a specific questionnaire: Infant Breastfeeding Assessment Tool (IBFAT).
Time to Full enteral nutrition [After 3 months]
Days from birth until Full enteral nutrition
Time in use of Nasogastric tube feeding [After 3 months]
Days from birth in use of Nasogastric tube feeding
Time to recovered birth weight [After 3 months]
Days from birth until recovered birth weight
Weight gain [Up to 12 months]
Weight gain from birth
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.
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.
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.
Maturation of EEG-pattern [Postnatal day 4-10 and postmenstrual age of 40-42 weeks]
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.
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 and at 12 and 24 months.]
A videotaped mother-infant interaction session will be assessed through with the Parent-Child Early Relational Assessment (PCERA)
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"
Parents' experiences [Up to 12 months]
Parents will fill in the following questionnaire: State-Trait Anxiety Index(STAI)
Parents' experiences [Up to 12 months]
Parents will fill in the following questionnaire: Swedish Parenting Questionnaire (SPSQ)
Parents' experiences [Up to 12 months]
Parents will fill in the following questionnaire: Edinburgh postnatal Depression Scale (EPDS)
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 Infant Behavior Questionnaire (IBQ)
Neuro Behaviour of Child [At term age, at 3-4, 12 and 24 months]
According to records and to questionnaires for example Bayley Scales
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stavanger University Hospital	Stavanger		Norway
2	Department of Women´s and Children´s Health, Karolinska University Hospital	Stockholm		Sweden	SE 171 77

Sponsors and Collaborators

Björn Westrup, MD PhD
University of Bergen

Investigators

Study Chair: Björn Westrup, MD,PhD, Department of Women´s and Children´s Health, Karolinska Institutet, Stockholm, Sweden
Principal Investigator: Siren Rettedal, MD, PhD, Stavanger University Hospital, Stavanger, Norway
Principal Investigator: Wibke Jonas, Ass prof, Department of Women´s and Children´s Health, Karolinska Institutet, Stockholm, Sweden