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

Developmental Delay Clinical Trial

— 18mo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426698
• Other study ID #: Mercer - 9625
• Status: Completed
• Phase: Phase 2
• First received: August 19, 2011
• Last updated: December 3, 2014
• Start date: August 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Weeks to 31 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Developmental Delay

Intervention

Procedure:
• delayed cord clamping
at birth, the obstetrical provider delays the cord clamping for 45 seconds while lowering the infant. At 45 seconds the cord is milked once and then clamped and cut.

Locations

Country	Name	City	State
United States	Women & Infants Hospital of Rhode Island	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
University of Rhode Island	Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mercer JS, Vohr BR, Erickson-Owens DA, Padbury JF, Oh W. Seven-month developmental outcomes of very low birth weight infants enrolled in a randomized controlled trial of delayed versus immediate cord clamping. J Perinatol. 2010 Jan;30(1):11-6. doi: 10.1038/jp.2009.170. Epub 2009 Oct 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor function	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.	18-22 months	Yes
Secondary	Mental Functioning	Very low birth weight infants in the delayed cord-clamping group will have better mental functions at 18-22 months corrected age when compared with VLBW infants in the ICC group.	18 to 22 months	Yes