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OpenTrials
Completed

NCT Number: NCT04881071

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Consorci Sanitari Alt Penedes i Garraf

Sant Pere de Ribes, Barcelona, 08810, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Moders attending the first hospital visit with the midwife, with delivery planned in either of the two study hospitals

Exclusion criteria

  • Language barrier that prevents collaboration in the study procedures
  • Cognitive impairment preventing collaboration in the study procedures
  • Morbid obesity

Treatment and study plan

Scarf

Device

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

usual clinical practice

Other

Participants will receive the usual clinical practice

Primary outcomes

  1. Mother-neonate skin-to-skin contact time (number of hours)

    Time frame: 72 hours

    Number of hours of skin-to-skin contact maneuver (kangaroo)

Secondary outcomes

  1. Time in arms or in physical contact of the neonate with the mother / father

    Time frame: 72 hours

    Number of hours in arms or in physical contact of the neonate with the mother / father

  2. Time of crying

    Time frame: 72 hours

    Number of hours crying

  3. Newborn weight loss

    Time frame: 72 hours

    Weight change in grams

  4. Parents satisfaction with hospital care

    Time frame: 72 hours

    Parents satisfaction (structured interview)

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Other

Registry information

Official study title

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

Acronym: MOKA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 11, 2021
Registry last updated
Dec 5, 2025

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.