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

Infant, Newborn, Disease Clinical Trial

— PAPSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04034719
• Other study ID #: 19CH089
• Secondary ID: 2019-A01113-54
• Status: Completed
• Phase: N/A
• Start date: October 8, 2019
• Est. completion date: March 22, 2022

Study information

• Verified date: January 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 22, 2022
• Est. primary completion date: October 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Infant, Newborn, Disease
• Infant, Newborn, Diseases

Intervention

Other:
• portage scarf
Parents will be carried their newborn with the portage scarf provided by the department.
• usual practice
Parents will be carried their newborn as their usual practice.

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of minuts with portage skin-to-skin	Measured in minutes by the time sheet of presence.	From inclusion to 2 months after exit