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Completed

NCT Number: NCT04034719

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

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.

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Key information

Conditions

Infant, Newborn, Disease Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Saint-Etienne

Saint-Etienne, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

portage scarf

Other

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

Usual practice

Other

Parents will be carried their newborn as their usual practice.

Primary outcomes

  1. Number of minuts with portage skin-to-skin

    Time frame: From inclusion to 2 months after exit

    Measured in minutes by the time sheet of presence.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: PAPSE

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 26, 2019
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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