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

Primary Purpose

Infant, Newborn, Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

portage scarf

usual practice

About this trial

This is an interventional supportive care trial for Infant, Newborn, Disease focused on measuring Newborn, Parents, Carrying, Skin-to-skin, Scarf

Eligibility Criteria

undefined - 10 Weeks (Child)All SexesDoes not accept 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

Sites / Locations

CHU Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm 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

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

Outcomes

Primary Outcome Measures

Number of minuts with portage skin-to-skin

Measured in minutes by the time sheet of presence.

Secondary Outcome Measures

Full Information

NCT ID

NCT04034719

First Posted

July 23, 2019

Last Updated

August 23, 2022

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

1. Study Identification

Unique Protocol Identification Number

NCT04034719

Brief Title

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

Acronym

PAPSE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

October 8, 2019 (Actual)

Primary Completion Date

October 18, 2021 (Actual)

Study Completion Date

March 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infant, Newborn, Disease

Keywords

Newborn, Parents, Carrying, Skin-to-skin, Scarf

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm 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

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

portage scarf

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

usual practice

Intervention Description

Parents will be carried their newborn as their usual practice.

Primary Outcome Measure Information:

Title

Number of minuts with portage skin-to-skin

Description

Measured in minutes by the time sheet of presence.

Time Frame

From inclusion to 2 months after exit

10. Eligibility

Sex

All

Maximum Age & Unit of Time

10 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hugues PATURAL, MD PhD

Organizational Affiliation

CHU SAINT-ETIENNE

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Saint-Etienne

City

Saint-Étienne

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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