Protective Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants
| Status: | Archived |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | February 2008 |
| End Date: | January 2013 |
Protective Effects of Delayed Cord Clamping in VLBW Infants
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 NICU and better motor skills at 7 months of age. The investigators
will attempt to identify the mechanisms of effect through measurement of biologic markers.
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 (IL-6 and VEGF), 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.
We found this trial at
1
site
Click here to add this to my saved trials
