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

Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03521310
• Other study ID #: IPISTOSS
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: October 12, 2021

Study information

• Verified date: December 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. completion date: October 12, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

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.
• Conventional care
Neonates will get Conventional care the first 72 hours after birth

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger
Sweden	Department of Women´s and Children´s Health, Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Björn Westrup, MD PhD	University of Bergen

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory stability	Using the Stability of the CardioRespiratory system In the Preterm-score (SCRIP-score). A higher SCRIP score indicates greater physiological stability	After six hours
Secondary	Need for respiratory support	Days in respirator from birth to discharge from hospital	After 3 months
Secondary	Need for surfactant	Number of doses of surfactants from birth to discharge from hospital,	After 3 months
Secondary	Need of Continuous positive airway pressure	Days in use of Continuous positive airway pressure (CPAP)- from birth to discharge from hospital	After 3 months
Secondary	Need for oxygen	Days in use of oxygen from birth to discharge from hospital	After 3 months
Secondary	Heart Rate Variability		Up to 3-4 months
Secondary	Body temperature	Axillary body temperature	At 0 hour (postpartum), 1, 2, 3, 4, 5 and 6 hours
Secondary	Sepsis episodes	Number of Sepsis episodes from birth to discharge from hospital, based on the Medical records	After 3 months
Secondary	Number of Antibiotic treatment	Number of Days with antibiotic treatment from birth to discharge from hospital based on Medical records	After 3 months
Secondary	Status of Breast-feeding	Status of Breast-feeding according to a specific questionnaire: Index of Breastfeeding (IBS)	Up to12 months
Secondary	Status of Breast-feeding	Status of Breast-feeding according to a specific questionnaire: Breastfeeding Self efficacy Questionnaire (BSES)	Up to12 months
Secondary	Status of Breast-feeding	Status of Breast-feeding according to a specific questionnaire: Infant Breastfeeding Assessment Tool (IBFAT).	Up to12 months
Secondary	Time to Full enteral nutrition	Days from birth until Full enteral nutrition	After 3 months
Secondary	Time in use of Nasogastric tube feeding	Days from birth in use of Nasogastric tube feeding	After 3 months
Secondary	Time to recovered birth weight	Days from birth until recovered birth weight	After 3 months
Secondary	Weight gain	Weight gain from birth	Up to 12 months
Secondary	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.	Up to 24 months
Secondary	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.	Up to 24 months
Secondary	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.	Up to 24 months
Secondary	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	Up to 24 months
Secondary	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.	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.
Secondary	Maturation of EEG-pattern		Postnatal day 4-10 and postmenstrual age of 40-42 weeks
Secondary	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.	At term age
Secondary	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.	At 4 months
Secondary	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)	At 3-4 months and at 12 and 24 months.
Secondary	Bonding and interaction between parent and child	A videotaped mother-infant interaction session will be assessed through the "Still Face situation"	At 3-4 months
Secondary	Parents' experiences	Parents will fill in the following questionnaire: State-Trait Anxiety Index(STAI)	Up to 12 months
Secondary	Parents' experiences	Parents will fill in the following questionnaire: Swedish Parenting Questionnaire (SPSQ)	Up to 12 months
Secondary	Parents' experiences	Parents will fill in the following questionnaire: Edinburgh postnatal Depression Scale (EPDS)	Up to 12 months
Secondary	Maternal-Child physiological attunement in stress regulation	Saliva Cortisol both mother and child	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.
Secondary	Neuro Behaviour of Child	According to records and to questionnaires for example Infant Behavior Questionnaire (IBQ)	At term age, at 3-4, 12 and 24 months
Secondary	Neuro Behaviour of Child	According to records and to questionnaires for example Bayley Scales	At term age, at 3-4, 12 and 24 months
Secondary	Neuro Behaviour of Child	According to records and to questionnaires for example Ages and Stages Questionnaire (ASQ)	At term age, at 3-4, 12 and 24 months