Full-term Newborn BabiesMOKANCT04881071
Efficacy of a Scarf to Facilitate Mother-newborn Contact Designed to Facilitate Skin-to-skin Contact
A study testing Scarf and Usual clinical practice in people with Full-term Newborn Babies, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Full-term Newborn Babies
- What is being tested?
- Scarf and Usual clinical practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2021to 21 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moders attending the first hospital visit with the midwife, with delivery planned in either of the two study hospitals
Who cannot join
- Language barrier that prevents collaboration in the study procedures
- Cognitive impairment preventing collaboration in the study procedures
- Morbid obesity
Trial locations and contacts
1 site in 1 country.
Spain1 site
Consorci Sanitari Alt Penedes i Garraf
Sant Pere de Ribes, Barcelona, 08810
About this study
Official title: 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.
- Conditions
- Full-term Newborn Babies
- Being tested
- Scarf, Usual clinical practice
- Keywords
- Kangaroo-Mother Care Method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScarfDevice
Scarf specifically designed to facilitate mother-neonate skin-to-skin contact
Usual clinical practiceOther
Participants will receive the usual clinical practice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother-neonate skin-to-skin contact time (number of hours)
Number of hours of skin-to-skin contact maneuver (kangaroo)
Measured: 72 hours
Secondary outcomes (4)
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
Measured: 72 hours
Time of crying
Number of hours crying
Measured: 72 hours
Newborn weight loss
Weight change in grams
Measured: 72 hours
Parents satisfaction with hospital care
Parents satisfaction (structured interview)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start1 May 2021
- Primary completion1 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Full-term Newborn BabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Bernadó, Principal investigator, Consorci Sanitari Alt Penedes i GarrafAlejandro Rodríguez-Molinero, Study director, Consorci Sanitari Alt Penedes i Garraf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881071
- Sponsor's protocol ID
- CSAPG-14
- Acronym
- MOKA
- Status last verified
- Dec 2025
- First submitted
- 30 Apr 2021
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
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. 2026 Apr;173(1):445-455. doi: 10.1002/ijgo.70635. Epub 2025 Nov 11.
PubMed 41216986
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Efficacy of a Scarf Designed to Facilitate Skin-to-skin Contact Between Parents and Healthy Term Neonates
- ClinicalTrials.gov ID
- NCT04881071
- Acronym / sponsor ID
- MOKA / CSAPG-14
- Conditions
- Full-term Newborn Babies
- Keywords
- Kangaroo-Mother Care Method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scarf | Experimental | Device: ScarfTwo 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. |
| Usual clinical practice | Active comparator | Other: Usual clinical practiceTwo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moders attending the first hospital visit with the midwife, with delivery planned in either of the two study hospitals
Key exclusion criteria (3 listed)
- Language barrier that prevents collaboration in the study procedures
- Cognitive impairment preventing collaboration in the study procedures
- Morbid obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScarfScarf specifically designed to facilitate mother-neonate skin-to-skin contact | Device | Scarf |
| Usual clinical practiceParticipants will receive the usual clinical practice | Other | Usual clinical practice |
Primary outcome
Mother-neonate skin-to-skin contact time (number of hours)
Time frame: 72 hours
Number of hours of skin-to-skin contact maneuver (kangaroo)
4 secondary outcomes
Time in arms or in physical contact of the neonate with the mother / father
Time frame: 72 hours
Time of crying
Time frame: 72 hours
Newborn weight loss
Time frame: 72 hours
Parents satisfaction with hospital care
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Results publication: PubMed 41216986Bernado 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Bernadó principal investigator
Consorci Sanitari Alt Penedes i Garraf
Alejandro Rodríguez-Molinero study director
Consorci Sanitari Alt Penedes i Garraf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scarf and Usual clinical practice in people with Full-term Newborn Babies, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother-neonate skin-to-skin contact time (number of hours) (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04881071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.