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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT04034719

Collaborator

(none)

Enrollment

Location

Arms

29.4

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infant, Newborn, Disease	Other: portage scarf Other: usual practice	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 8, 2019

Actual Primary Completion Date :

Oct 18, 2021

Actual Study Completion Date :

Mar 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group 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 Parents will be carried their newborn with the portage scarf provided by the department.
Active Comparator: Control group Newborn hospitalized in the neonatal department with their parent will be included. They wont have a portage scarf.	Other: usual practice Parents will be carried their newborn as their usual practice.

Arm

Intervention/Treatment

Experimental: Experimental group

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

Parents will be carried their newborn with the portage scarf provided by the department.

Active Comparator: Control group

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

Other: usual practice

Parents will be carried their newborn as their usual practice.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 10 Weeks

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Saint-Etienne	Saint-Étienne		France

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator: Hugues PATURAL, MD PhD, CHU SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Saint Etienne

ClinicalTrials.gov Identifier:

NCT04034719

Other Study ID Numbers:

19CH089
2019-A01113-54

First Posted:

Jul 26, 2019

Last Update Posted:

Aug 24, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

Additional relevant MeSH terms:

Infant, Newborn, Diseases

Study Results

No Results Posted as of Aug 24, 2022