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

Consorci Sanitari de l'Alt Penedès i Garraf

Status: Completed

Conditions: Full-term Newborn Babies

Treatments: Device: Scarf; Other: Usual clinical practice

Study type: Interventional

Funder types: Other

Identifiers

NCT04881071

CSAPG-14

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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143 participants in 2 patient groups

Scarf

Experimental group

Description:

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.

Treatment:

Device: Scarf

Usual clinical practice

Active Comparator group

Description:

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.

Treatment:

Other: Usual clinical practice