Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
- Conditions
- Neurodevelopmental Abnormality
- Registration Number
- NCT03621943
- Lead Sponsor
- Sharp HealthCare
- Brief Summary
A sub-study to evaluate longer-term developmental outcomes in non-vigorous term and near-term newborns who receive umbilical cord milking in comparison to those who undergo early cord clamping at delivery.
- Detailed Description
This sub-study investigates the potential difference in neurodevelopmental outcomes during early childhood between newborns who undergo umbilical cord milking and those who experience early cord clamping at birth. The developmental progress of participants is evaluated using the Ages and Stages Questionnaire-3 which measures five developmental areas: communication, problem-solving, fine motor skills, gross motor skills, and personal-social behavior. Additionally, the Modified Checklist for Autism in Toddlers is employed as a secondary assessment. The recruitment of participants is conducted through the primary study Umbilical Cord Milking in Nonvigorous Infants trial (NCT03631940) with the method of umbilical cord management for each newborn being dictated by the randomized treatment allocation of the primary study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1207
- Enrolled in the primary trial NCT:03631940 and parental written consent to participate in developmental follow-up through 2 years of age was obtained.
- Enrolled in the primary trial NCT:03631940 and did not survive to 2 years.
- Enrolled in the primary trial NCT:03631940 but parent/guardian declined consent to developmental follow-up participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Total and Domain Scores on the Ages and Stages Questionnaire, Third Edition. 22 to 26 months Neurodevelopmental Outcome at 2 Years of Age defined as overall and domain scores on the Ages and Stages, third edition. Questionnaire. Minimum score of 0 and maximum score of 60 per domain. Scores from 5 subscales are summed to obtain a total score. 5 domains assessed include communication, gross motor, fine motor, problem solving, personal social with a total minimum score of 0 and maximum score of 300. Higher scores indicate a lower risk of developmental delays or conditions
- Secondary Outcome Measures
Name Time Method Score Ranges on the Modified Checklist for Autism in Toddlers Questionnaire 22-26 months Modified Checklist for Autism in Toddlers. Minimum score of 0 and maximum score of 20. Higher scores indicate higher risk for autism spectrum disorder. Total scores of 0 to 2 indicates a low risk of autism spectrum disorder. Total scores of 3 to 7 indicates a moderate risk of autism spectrum disorder. Total scores of 8 to 20 indicate high risk of autism spectrum disorder.
Trial Locations
- Locations (10)
University of California, Davis
🇺🇸Davis, California, United States
Loma Linda Medical Center
🇺🇸Loma Linda, California, United States
Sharp Grossmont Hospital
🇺🇸San Diego, California, United States
Sharp Mary Birch Hospital for Women and Newborns
🇺🇸San Diego, California, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
University of Utah/IMH
🇺🇸Salt Lake City, Utah, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Dalhousie University
🇨🇦Dalhousie, New Brunswick, Canada
Poznan University of Medical Science
🇵🇱Poznań, Poland
University of California, Davis🇺🇸Davis, California, United States