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

NCT04881071 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2025-12-05

No results posted yet for this study

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

DEVICE

Scarf

Scarf specifically designed to facilitate mother-neonate skin-to-skin contact

OTHER

Usual clinical practice

Participants will receive the usual clinical practice

Sponsors & Collaborators

  • Consorci Sanitari de l'Alt Penedès i Garraf

    lead OTHER

Principal Investigators

  • Marta Bernadó · Consorci Sanitari Alt Penedes i Garraf

  • Alejandro Rodríguez-Molinero · Consorci Sanitari Alt Penedes i Garraf

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2023-07-01
Completion
2023-07-21

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04881071 on ClinicalTrials.gov