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

Not Applicable

Completed

• Conditions: Infant, Newborn, Disease
• Interventions: Other: portage scarf; Other: usual practice

• Registration Number: NCT04034719
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-26
• Study Start: 2019-10-08
• Primary Completion: 2021-10-18
• Status Verified: 2022-01
• Study Completion: 2022-03-22
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	portage scarf	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
Control group	usual practice	Newborn hospitalized in the neonatal department with their parent will be included. They wont have a portage scarf.

Primary Outcome Measures

Name	Time	Method
Number of minuts with portage skin-to-skin	From inclusion to 2 months after exit	Measured in minutes by the time sheet of presence.

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France