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

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

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.

Study Overview

• Status: Completed
• Conditions: Infant, Newborn, Disease
• Intervention / Treatment: Other: portage scarf; Other: usual practice

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 8, 2019
• Primary Completion (ACTUAL): October 18, 2021
• Study Completion (ACTUAL): March 22, 2022

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (ACTUAL): July 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Newborn; Parents; Skin-to-skin; Carrying; Scarf
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases
• Other Study ID Numbers: 19CH089; 2019-A01113-54 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No