N/A
N=605
Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
Neurodevelopmental Abnormality
Bottom Line
View on ClinicalTrials.gov: NCT03621943 ↗Enrolled (actual)
605
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Total and Domain Scores on the Ages and Stages Questionnaire, Third Edition. — 55; 55; 60; 60 score on a scale — p=0.87
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Umbilical Cord Milking (Procedure); Early Cord Clamping (Procedure)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sharp HealthCare
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total and Domain Scores on the Ages and Stages Questionnaire, Third Edition. |
55; 55; 60; 60; 50; 50 | 0.87 |
| SECONDARY Score Ranges on the Modified Checklist for Autism in Toddlers Questionnaire |
441; 404; 34; 31; 11; 6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Enrolled in the primary trial NCT: 03631940 but parent/guardian declined consent to developmental follow-up participation.
Data sourced from ClinicalTrials.gov (NCT03621943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.