Protective Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants

Sepsis Clinical Trial

Official title:

Protective Effects of Delayed Cord Clamping in VLBW Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818220
• Other study ID #: 2980022
• Secondary ID: 5R01NR010015-02
• Status: Completed
• Phase: Phase 2
• First received: January 5, 2009
• Last updated: May 26, 2015
• Start date: February 2008
• Est. completion date: March 2014

Study information

• Verified date: May 2015
• 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 determine whether the intervention of delaying cord clamping for 30 to 45 seconds followed by one milking of the cord while simultaneously lowering the VLBW infants below the introitus will result in less bleeding in the brain and fewer infections while in the Neonatal Intensive Care Unit (NICU) and better motor skills at 7 months corrected age. The investigators will attempt to identify the mechanisms of effect through measurement of biologic markers.

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 25% of the fetal-placental blood volume may be left in the placenta acutely increasing vulnerability to hypovolemia. Hypovolemia can precipitate a cascade of physiologic events including poor tissue perfusion, ischemia, and initiation of the fetal/neonatal inflammatory response. Intraventricular hemorrhage (IVH) is a major cause of brain injury for preterm infants and is a predictor of poor neurodevelopment outcomes. Late onset sepsis (LOS) is also associated with morbidity and mortality in the NICU and later developmental delay. Of the approximately 57,000 infants born annually at less than 1500 grams, 10% develop cerebral palsy and 25 to 50% show later cognitive and behavioral deficits affecting school performance with higher rates found in males. We propose a trial with a sample of 212 randomized infants to validate our prior findings that delaying the cord clamping lowers the incidence of intraventricular hemorrhage and late onset sepsis, and to identify the mechanisms of effect through the study of biologic markers including measurement of cytokines, circulating stem cells, and red cell volume. Enrolled women in preterm labor will be randomized at birth to the immediate cord clamping group or the delayed clamping group. Assessment of motor outcomes is planned at 7 months corrected age. This study will help to establish a scientific basis for the timing of cord clamping of VLBW infants. The innovation of this study is in the simplicity of delaying cord clamping for 30 to 45 seconds and lowering the VLBW infants at birth. This low-tech change in a clinical practice has the potential to reduce the risk of disease and disability and to improve the neonatal and early childhood outcomes for these most vulnerable preterm infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women between 24 and 31.6 weeks gestation at risk of delivery

• Vaginal or cesarean birth

Exclusion Criteria:

• Congenital anomaly

• Multiple gestation

• Intent to withhold or withdraw care

• Severe or multiple maternal illnesses

• Mothers who are institutionalized or psychotic

Study Design

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intraventricular Hemorrhage
• Sepsis

Intervention

Procedure:
• delayed umbilical cord clamping
at birth, the clamping of the umbilical cord will be delayed 30 to 45 seconds while the child is held lower than the placenta. At the end of the time, the cord is milked once and the cord is clamped. If the obstetrician feels he cannot delay the cord clamping, then the cord can be milked 2 to 3 times.

Other:
• Immediate cord clamping
The umbilical cord is cut within 10 seconds after birth

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
University of Rhode Island	Brown University, National Institute of Nursing Research (NINR), Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mercer JS, Vohr BR, McGrath MM, Padbury JF, Wallach M, Oh W. Delayed cord clamping in very preterm infants reduces the incidence of intraventricular hemorrhage and late-onset sepsis: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):1235-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Very low birth weight (VLBW) infants in the delayed cord clamping (DCC) group will have less intraventricular hemorrhage (IVH) compared to VLBW infants in the immediate clamped (ICC) group		December, 2012	No
Primary	Very low birth weight infants in the delayed cord clamping group will have less late onset sepsis than those in the immediate clamping group		December 2012	No
Secondary	VLBW infants in the DCC group will have better motor function at 7 months corrected age		November 2012	No