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

NCT ID: NCT04034719

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-08
• Study Completion Date: 2022-03-22

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).

Conditions

Infant, Newborn, Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

portage scarf

Intervention Type: OTHER

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

Control group

Newborn hospitalized in the neonatal department with their parent will be included.

They wont have a portage scarf.

Group Type: ACTIVE_COMPARATOR

usual practice

Intervention Type: OTHER

Parents will be carried their newborn as their usual practice.

Interventions

portage scarf

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

Intervention Type: OTHER

usual practice

Parents will be carried their newborn as their usual practice.

Intervention Type: OTHER

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

• Maximum Eligible Age: 10 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hugues PATURAL, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2019-A01113-54

Identifier Type: OTHER

Identifier Source: secondary_id

19CH089

Identifier Type: -

Identifier Source: org_study_id