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

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Infant, Newborn, Disease

Treatments: Other: portage scarf; Other: usual practice

Study type: Interventional

Funder types: Other

Identifiers

NCT04034719

2019-A01113-54 (Other Identifier)

19CH089

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 80 patients

Sex: All

Ages: Under 10 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Experimental group

Experimental group

Description:

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

Treatment:

Other: portage scarf

Control group

Active Comparator group

Description:

Newborn hospitalized in the neonatal department with their parent will be included. They wont have a portage scarf.

Treatment:

Other: usual practice