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

NCT04881071 | Completed

• 1 other identifier: CSAPG-14
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Kangaroo-Mother Care Method

Outcome Measures

Primary Outcomes (1)

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

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

  72 hours

Secondary Outcomes (4)

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

  72 hours

• Time of crying

  72 hours

• Newborn weight loss

  72 hours

• Parents satisfaction with hospital care

  72 hours

Study Arms (2)

Scarf

EXPERIMENTAL

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

Usual clinical practice

ACTIVE COMPARATOR

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

Interventions

Scarf DEVICE

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

Scarf

Usual clinical practice OTHER

Participants will receive the usual clinical practice

Usual clinical practice

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead

Study Sites (1)

Consorci Sanitari Alt Penedes i Garraf

Sant Pere de Ribes, Barcelona, 08810, Spain

Location

Related Publications (1)

• 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. 2026 Apr;173(1):445-455. doi: 10.1002/ijgo.70635. Epub 2025 Nov 11.

  PMID: 41216986 RESULT

Study Officials

• Marta Bernadó

  Consorci Sanitari Alt Penedes i Garraf

  PRINCIPAL INVESTIGATOR

• Alejandro Rodríguez-Molinero

  Consorci Sanitari Alt Penedes i Garraf

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 11, 2021
• Study Start: May 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 21, 2023
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After publication of main results of the study
• 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.

Locations

ES (1)