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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Rhode Island.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Women and Infants Hospital of Rhode Island
Information provided by (Responsible Party):
Judith S Mercer, University of Rhode Island
ClinicalTrials.gov Identifier:
NCT01426698
First received: August 19, 2011
Last updated: June 12, 2012
Last verified: June 2012

August 19, 2011
June 12, 2012
August 2011
January 2014   (final data collection date for primary outcome measure)
Motor function [ Time Frame: 18-22 months ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01426698 on ClinicalTrials.gov Archive Site
Mental Functioning [ Time Frame: 18 to 22 months ] [ Designated as safety issue: Yes ]
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.
Same as current
Not Provided
Not Provided
 
18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping Study
18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Developmental Delay
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.
Other Name: DCC
  • No Intervention: Immediate cord clamping
    Infants in this arm will have had immediate cord clamping at birth
    Intervention: Procedure: delayed cord clamping
  • Experimental: Delayed Cord Clamping
    Following the delivery of the infant, the obstetrician holds the infant approximately 10-15 inches below the mother's introitus at vaginal delivery or 10 to 15 inches below the level of the placenta at Cesarean section. The research nurse records the time when the infant's buttocks are delivered from the vagina or the uterus and counts out the time elapsed in ten second intervals to the obstetrician while he/she is doing the suctioning and drying maneuvers. At 30 to 45 seconds, the obstetrician milks the umbilical cord once, clamps, and cuts it. If the baby appears jeopardized in any way, the obstetrician can alter the protocol for the safety of the infant.
    Intervention: Procedure: delayed cord clamping
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. Epub 2009 Oct 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
212
July 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
24 Weeks to 31 Weeks
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01426698
Mercer - 9625
Yes
Judith S Mercer, University of Rhode Island
University of Rhode Island
Women and Infants Hospital of Rhode Island
Principal Investigator: Judith S Mercer, PhD, CNM Women and Infants Hospital of Rhode Island
University of Rhode Island
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP