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

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

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.

Study Overview

• Status: Completed
• Conditions: Full-term Newborn Babies
• Intervention / Treatment: Device: Scarf; Other: Usual clinical practice

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sant Pere de Ribes, Barcelona, Spain, 08810
      • Consorci Sanitari Alt Penedes i Garraf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scarf; Two hours after delivery, mothers will be informed of the benefits of the skin-to-skin method, and the towel with which mother and newborn are covered from the moment of delivery will be replaced by a NeoBulleⓇ scarf. This scarf, which can be used by the mother and/or her partner, is specific for practicing the "skin-to-skin" technique. It facilitates breastfeeding posture, keeps the newborn well covered and supported on the back. The NeoBulleⓇ scarf is not a baby carrier device that allows standing or walking without holding the baby with the arms. Nursing staff will ensure the proper understanding of scarf usage instructions by parents and provide them with written instructions. Mother and newborn will remain with the NeoBulleⓇ scarf placed in the delivery area until they are transferred to the hospitalization unit. Once in the hospitalization unit, mothers will have the option to continue contact with the baby using the scarf or dress the newborn.	Device: Scarf; Scarf specifically designed to facilitate mother-neonate skin-to-skin contact
Active Comparator: Usual clinical practice; Two hours after delivery, mothers will be informed about the benefits of the skin-to-skin method, and the traditional practice in the study centers will be followed, whereby the newborn remains in contact with the mother, covered by a towel, from the moment of birth until both are transferred to the hospitalization unit. In the hospitalization unit, they will have the option to continue in this manner or dress the newborn.	Other: Usual clinical practice; Participants will receive the usual clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mother-neonate skin-to-skin contact time (number of hours)	Number of hours of skin-to-skin contact maneuver (kangaroo)	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newborn weight loss	Weight change in grams	72 hours
Parents satisfaction with hospital care	Parents satisfaction (structured interview)	72 hours
Time in arms or in physical contact of the neonate with the mother / father	Number of hours in arms or in physical contact of the neonate with the mother / father	72 hours
Time of crying	Number of hours crying	72 hours

Collaborators and Investigators

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
• Investigators: Principal Investigator: Marta Bernadó, Consorci Sanitari Alt Penedes i Garraf; Study Director: Alejandro Rodríguez-Molinero, Consorci Sanitari Alt Penedes i Garraf

Publications and helpful links

General Publications

• Bernado Vidal M, Galvez-Barron C, Perez-Lopez C, Adridar F, Mayol Fiol M, Ponce Molina MP, Herzog de Samaniego V, Saiz Sanz L, Miro B, Perez-Hoyos S, Torres Soto AJ, Martinez Dalmases R, Calero Bajoz T, Rodriguez-Molinero A. A specifically designed handkerchief for skin-to-skin care: A randomized controlled trial in Spain. Int J Gynaecol Obstet. 2025 Nov 11. doi: 10.1002/ijgo.70635. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 21, 2023

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Estimated): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Kangaroo-Mother Care Method
• Other Study ID Numbers: CSAPG-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research proposels and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
• IPD Sharing Time Frame: After publication of main results of the study
• IPD Sharing Access Criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No