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Completed

NCT Number: NCT01426698

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.

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Key information

Age range

24 week–31 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delayed Cord Clamping

Procedure

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

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Rhode Island

Other

Collaborators

  • Women and Infants Hospital of Rhode Island

Registry information

Acronym: 18mo

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 31, 2011
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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