Benefit of Scarf Support on Skin-to-skin Time and Portage in Neonatology and at Home

Study Overview
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Brief Summary
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Carrying (or kangaroo carrying) is known to reduce neonatal and child morbidity and mortality and improves the quality of survival of premature and term children during the most fragile growth period, the first thousand days of life. Carrying is also a growing brain protection technique and becomes a routine of care in all neonatal units around the world. In University hospital of Saint-Etienne, the developmental care program has been developed since 2002 in all neonatology units and advocates the practice of skin-to-skin carrying between the parent (father or mother) and his baby, from the time of the hospitalization. Professionals in units who have long been thinking about the concept of attachment and the benefits of skin-to-skin, wish to validate the use of the wearing scarf as a tool for the practice of skin -in-skin in neonatology then back home by performing a randomized monocentric prospective longitudinal study.

Detailed Description
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This study it's a single-center, prospective, randomized study to evaluate the benefit of the scarf in the practice of skin-to-skin and portage (PAPSE Group) compared to a Skin-to-Skin and Carry Without Scarf (PAP group).

Official Title
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Benefit of Scarf Support on Skin-to-skin Time and Portage in Neonatology and at Home(PAPSE)

Conditions
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Infant, Newborn, Disease

Intervention / Treatment
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* Other: portage scarf
* Other: usual practice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For the child: Any newborn regardless of gestational age and postnatal age hospitalized in the neonatology department of the University Hospital of Saint-Etienne For the parent (father or mother): Be a parent of a child eligible for the research protocol Exclusion Criteria: For the child: Need for sedation or analgesia for the duration of the study Orthopedic pathology incompatible with the practice of carrying Other medical contraindications to carriage Absence of parents For the parent (father or mother): Family, social or psychological situation compromising the evaluation No fluency in the French language

Ages Eligible for Study
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Maximum Age: 10 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Newborn hospitalized in the neonatal department with their parent will be included. They will have a portage scarf to help them to keep their child skin-to-skin | Other: portage scarf<br>* Parents will be carried their newborn with the portage scarf provided by the department.<br>|
| Active Comparator: Control group<br>Newborn hospitalized in the neonatal department with their parent will be included. They wont have a portage scarf. | Other: usual practice<br>* Parents will be carried their newborn as their usual practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of minuts with portage skin-to-skin | Measured in minutes by the time sheet of presence. | From inclusion to 2 months after exit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Newborn, Parents, Carrying, Skin-to-skin, Scarf