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
  Purpose

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.


Condition Intervention Phase
Developmental Delay
Procedure: delayed cord clamping
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping Study

Further study details as provided by University of Rhode Island:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 212
Study Start Date: August 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Immediate cord clamping
Infants in this arm will have had immediate cord clamping at birth
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   24 Weeks to 31 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426698

Locations
United States, Rhode Island
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
University of Rhode Island
Women and Infants Hospital of Rhode Island
Investigators
Principal Investigator: Judith S Mercer, PhD, CNM Women and Infants Hospital of Rhode Island
  More Information

Publications:
Responsible Party: Judith S Mercer, Clinical Professor, University of Rhode Island
ClinicalTrials.gov Identifier: NCT01426698     History of Changes
Other Study ID Numbers: Mercer - 9625
Study First Received: August 19, 2011
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rhode Island:
delayed cord clamping
developmental delay

ClinicalTrials.gov processed this record on October 23, 2014