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Clinical Trials/NCT01426698
NCT01426698
Completed
Phase 2

18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping Study

University of Rhode Island1 site in 1 country208 target enrollmentAugust 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Developmental Delay
Sponsor
University of Rhode Island
Enrollment
208
Locations
1
Primary Endpoint
Motor function
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this study is to examine differences in the long-term effects of immediate versus delayed cord clamping at birth on developmental outcomes of our study infants at 18-22 months corrected age.

Detailed Description

The current obstetrical practice at birth in the United States is that the umbilical cord of the very low birth weight (VLBW) infant is clamped immediately. When immediate cord clamping occurs, up to 50% of the fetal-placental blood volume may be left in the placenta acutely increasing vulnerability to hypovolemia (low blood volume). In the investigators previous randomized control trial, it was found that infants who received a simple delay in umbilical cord clamping for 30-45 seconds experienced significantly lower incidence of bleeding in the brain and fewer systemic infections throughout the Neonatal Intensive Care Unit (NICU) stay and had higher scores on muscular control and function at 7 months corrected age. In the investigators current Phase 2 randomized controlled trial, examines the motor functioning of infants randomized to immediate cord clamping (ICC) or delayed cord clamping (DCC) at 7 months corrected age (age based on due date and not the pre-term birth rate). Our objective for this new grant from the Thrasher Foundation is to examine the differences in the long-term effects of ICC vs. DCC on developmental outcomes of our study infants at 18-22 months corrected age. The investigators hypothesis is that the positive effects of DCC, less bleeding in the brain and less infection, may also result in better motor and mental functioning at 18-22 months corrected age. Differentiation between cognitive and motor function is more obvious in the developing toddler than in younger infants. The diagnosis of cerebral palsy becomes more definitive with age and cognitive skills such as expressive and receptive language continue to emerge.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
December 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Judith S Mercer

Clinical Professor

University of Rhode Island

Eligibility Criteria

Inclusion Criteria

  • pregnancy between 24 and 31.6 weeks
  • singleton fetus
  • threatened preterm birth.

Exclusion Criteria

  • Fetuses: congenital anomalies
  • Mothers: severe or multiple maternal illnesses
  • Drug users or institutionalized or psychotic women

Outcomes

Primary Outcomes

Motor function

Time Frame: 18-22 months

Very low birth weight infants in the delayed cord-clamping group will have better motor function at 18-22 months corrected age when compared with VLBW infants in the ICC group.

Secondary Outcomes

  • Mental Functioning(18 to 22 months)

Study Sites (1)

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