NCT04881071

Efficacy of a Scarf to Facilitate Mother-newborn Contact Designed to Facilitate Skin-to-skin Contact

Randomized Clinical Trial to Evaluate the Efficacy of a Scarf Designed to Facilitate Skin-to-skin Contact Between Parents and Healthy Term Neonates

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The skin-to-skin contact maneuver (kangaroo) has shown benefits in newborn babies. This is two-arm randomized open clinical trial to evaluate whether the use of a scarf specifically designed to facilitate the skin-to-skin method is effective in terms of increasing the skin-to-skin mother-neonate time, compared to traditional clinical practice. Mothers of full-term babies with expected delivery in the study centers will be included. Those mothers with a language barrier that prevents collaboration in the study procedures, cognitive impairment or morbid obesity will be excluded. The primary endpoint is the average daily skin-to-skin time during hospital admission days. A superiority analysis will be made in terms of the skin-to-skin time of the intervention arm, compared to the control arm.

Conditions

• Full-term Newborn Babies

Interventions

Type	Name	Description
DEVICE	Scarf	Scarf specifically designed to facilitate mother-neonate skin-to-skin contact
OTHER	Usual clinical practice	Participants will receive the usual clinical practice

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-07-01
• Completion: 2023-07-21
• First posted: 2021-05-11
• Last updated: 2025-12-05

Locations

1 site across 1 country: Spain