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

NCT04034719 | Completed

• 2 other identifiers: 19CH0892019-A01113-54
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Newborn, Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of minuts with portage skin-to-skin

  Measured in minutes by the time sheet of presence.

  From inclusion to 2 months after exit

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Other: usual practice

Interventions

portage scarf OTHER

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

Experimental group

usual practice OTHER

Parents will be carried their newborn as their usual practice.

Control group

Eligibility Criteria

• Age: Up to 10 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hugues PATURAL, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 26, 2019
• Study Start: October 8, 2019
• Primary Completion: October 18, 2021
• Study Completion: March 22, 2022
• Last Updated: August 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)