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

December 3, 2014 updated by: Judith S Mercer, University of Rhode Island
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women & Infants Hospital of Rhode Island

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate cord clamping
Infants in this arm will have had immediate cord clamping at birth which is routine care at the hospital
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 Names:
  • DCC
Experimental: Delayed Cord Clamping
Intervention: 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 Names:
  • DCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18-22 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental Functioning
Time Frame: 18 to 22 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rhode Island

Collaborators

Women and Infants Hospital of Rhode Island

Investigators

  • Principal Investigator: Judith S Mercer, PhD, CNM, Women and Infants Hospital of Rhode Island

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 19, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (Estimate)

August 31, 2011

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Mercer - 9625

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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