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

Not Applicable

Completed

• Conditions: Full-term Newborn Babies

• Registration Number: NCT04881071
• Lead Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-30
• Study Start: 2021-05-01
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-11
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mother-neonate skin-to-skin contact time (number of hours)	72 hours	Number of hours of skin-to-skin contact maneuver (kangaroo)

Secondary Outcome Measures

Name	Time	Method
Time in arms or in physical contact of the neonate with the mother / father	72 hours	Number of hours in arms or in physical contact of the neonate with the mother / father
Time of crying	72 hours	Number of hours crying
Newborn weight loss	72 hours	Weight change in grams
Parents satisfaction with hospital care	72 hours	Parents satisfaction (structured interview)

Trial Locations

Locations (1)

Consorci Sanitari Alt Penedes i Garraf; 🇪🇸 Sant Pere De Ribes, Barcelona, Spain