Clinical trial NCT03621943: Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
Official title: Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurodevelopmental Abnormality
Keywords: Neurodevelopmental outcomes
Disability
Umbilical cord milking
Early cord clamping
Non-vigorous infants
Term infants
Near-Term infants
Developmental screening
Early childhood
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 1207
Sex: ALL
Minimum age (years): 22
Maximum age (years): 26
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization assignment was determined at time of enrollment in the primary study (Umbilical Cord Milking in Nonvigorous Infants Study NCT:03631940). The primary study model was a cluster randomized crossover trial.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Total and Domain Scores on the Ages and Stages Questionnaire, Third Edition.
timeFrame: 22 to 26 months
Secondary outcomes:
measure: Score Ranges on the Modified Checklist for Autism in Toddlers Questionnaire
timeFrame: 22-26 months
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
city: Loma Linda
country: United States
facility: Loma Linda Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Grossmont Hospital
state: California
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Salt Lake City
country: United States
facility: University of Utah/IMH
state: Utah
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Dalhousie
country: Canada
facility: Dalhousie University
state: New Brunswick
city: Poznań
country: Poland
facility: Poznan University of Medical Science
Study officials:
affiliation: Neonatologist
name: Anup Katheria, MD
role: PRINCIPAL_INVESTIGATOR
References: