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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scarf | Device | Scarf specifically designed to facilitate mother-neonate skin-to-skin contact |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
- Moders attending the first hospital visit with the midwife, with delivery planned in either of the two study hospitals
Exclusion Criteria:
Pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Marta Bernadó | Consorci Sanitari Alt Penedes i Garraf | Principal Investigator |
| Alejandro RodrÃguez-Molinero | Consorci Sanitari Alt Penedes i Garraf | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorci Sanitari Alt Penedes i Garraf | Sant Pere de Ribes | Barcelona | 08810 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41216986 | Result | 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. |
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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).
After publication of main results of the study
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.
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| Usual clinical practice |
| Other |
Participants will receive the usual clinical practice |
|
| 72 hours |
| Newborn weight loss | Weight change in grams | 72 hours |
| Parents satisfaction with hospital care | Parents satisfaction (structured interview) | 72 hours |