Clinical trial NCT03521310: Immediate Parent -Infant Skin-to-Skin Study (IPISTOSS)
Official title: Immediate Parent -Infant Skin-to-Skin Study (IPISTOSS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prematurity
Keywords: IPISTOSS
Skin to skin
SSC
Neonatal
kangaroo mother care
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2018-05-11
Enrollment: 91
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Cardiorespiratory stability
timeFrame: After six hours
Secondary outcomes:
measure: Need for respiratory support
timeFrame: After 3 months
measure: Need for surfactant
timeFrame: After 3 months
measure: Need of Continuous positive airway pressure
timeFrame: After 3 months
measure: Need for oxygen
timeFrame: After 3 months
measure: Heart Rate Variability
timeFrame: Up to 3-4 months
measure: Body temperature
timeFrame: At 0 hour (postpartum), 1, 2, 3, 4, 5 and 6 hours
measure: Sepsis episodes
timeFrame: After 3 months
measure: Number of Antibiotic treatment
timeFrame: After 3 months
measure: Status of Breast-feeding
timeFrame: Up to12 months
measure: Status of Breast-feeding
timeFrame: Up to12 months
measure: Status of Breast-feeding
timeFrame: Up to12 months
measure: Time to Full enteral nutrition
timeFrame: After 3 months
measure: Time in use of Nasogastric tube feeding
timeFrame: After 3 months
measure: Time to recovered birth weight
timeFrame: After 3 months
measure: Weight gain
timeFrame: Up to 12 months
measure: Epigenetic profiling in buccal cells
timeFrame: Up to 24 months
measure: Telomere profiling in buccal cells
timeFrame: Up to 24 months
measure: Epigenetic profiling in blood samples
timeFrame: Up to 24 months
measure: Telomere profiling in blood samples
timeFrame: Up to 24 months
measure: Microbiota
timeFrame: 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.
measure: Maturation of EEG-pattern
timeFrame: Postnatal day 4-10 and postmenstrual age of 40-42 weeks
measure: Structural and functional maturation of the infant brain
timeFrame: At term age
measure: Maternal brain responsiveness
timeFrame: At 4 months
measure: Bonding and interaction between parent and child
timeFrame: At 3-4 months and at 12 and 24 months.
measure: Bonding and interaction between parent and child
timeFrame: At 3-4 months
measure: Parents' experiences
timeFrame: Up to 12 months
measure: Parents' experiences
timeFrame: Up to 12 months
measure: Parents' experiences
timeFrame: Up to 12 months
measure: Maternal-Child physiological attunement in stress regulation
timeFrame: 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.
measure: Neuro Behaviour of Child
timeFrame: At term age, at 3-4, 12 and 24 months
measure: Neuro Behaviour of Child
timeFrame: At term age, at 3-4, 12 and 24 months
measure: Neuro Behaviour of Child
timeFrame: At term age, at 3-4, 12 and 24 months
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Stockholm
country: Sweden
facility: Department of Women´s and Children´s Health, Karolinska University Hospital
Study officials:
affiliation: Department of Women´s and Children´s Health, Karolinska Institutet, Stockholm, Sweden
name: Björn Westrup, MD,PhD
role: STUDY_CHAIR
affiliation: Stavanger University Hospital, Stavanger, Norway
name: Siren Rettedal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Women´s and Children´s Health, Karolinska Institutet, Stockholm, Sweden
name: Wibke Jonas, Ass prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.