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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04881071
Acronym
MOKA
Enrollment
143
Registered
2021-05-11
Start date
2021-05-01
Completion date
2023-07-21
Last updated
2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Full-term Newborn Babies

Keywords

Kangaroo-Mother Care Method

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.

Interventions

DEVICEScarf

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

Participants will receive the usual clinical practice

Sponsors

Consorci Sanitari de l'Alt Penedès i Garraf
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mother-neonate skin-to-skin contact time (number of hours)72 hoursNumber of hours of skin-to-skin contact maneuver (kangaroo)

Secondary

MeasureTime frameDescription
Time in arms or in physical contact of the neonate with the mother / father72 hoursNumber of hours in arms or in physical contact of the neonate with the mother / father
Time of crying72 hoursNumber of hours crying
Newborn weight loss72 hoursWeight change in grams
Parents satisfaction with hospital care72 hoursParents satisfaction (structured interview)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026