Intraventricular Hemorrhage, Premature Infants, Very Low Birth Weight Infants
Conditions
Keywords
delayed cord clamping
Brief summary
The purpose of this study is to determine if there is a difference in neonatal outcomes with delayed umbilical cord clamping at 30 versus 60 seconds. Our primary outcome will be intraventricular hemorrhage (IVH) (bleeding in the brain) in these infants.
Detailed description
Immediately following delivery, up to 40% of the total blood volume available to the infant is in the placenta. Over a period of 30 seconds to 3 minutes, a significant portion of this blood is transferred to the infant through the umbilical cord. Delayed cord clamping following delivery facilitates this transfer of blood. Preterm infants are very susceptible to the effects of anemia and hypovolemia. A recent meta-analysis showed that a brief delay in umbilical cord clamping (30-60 seconds) decreases the risk of anemia, blood transfusion, intraventricular hemorrhage, necrotizing enterocolitis, and the need for blood pressure support after delivery. The same meta-analysis showed no impact on Apgar scores or hypothermia due to a brief delay in resuscitation efforts to allow delayed cord clamping. Preterm infants are at significant risk for IVH and as high as 20% of very low birth weight infants will have it. IVH is an important cause of brain injury in these infants. In our study, we would like to determine the optimal timing of delayed cord clamping in order to prevent IVH in these infants.
Interventions
PROCEDUREDelayed cord clamping at 30 seconds
For subjects enrolled in the 30 second arm, the umbilical cord will be clamped at exactly 30 seconds after delivery
PROCEDUREDelayed cord clamping at 60 seconds
For subjects enrolled in the 60 second arm, the umbilical cord will be clamped at exactly 60 seconds after delivery
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant women who are expected to deliver a very low birth weight infant * Neonates born weighing \>= 500g and \<1500 grams * Mother 18 years of age or older * English speaking mother
Exclusion criteria
* Placental abruption * Vasa previa * Fetal hydrops or other signs of fetal volume overload * Other major fetal anomalies * Placenta Accreta * Mother \< 18 years of age * Non-English speaking mother * Infants \>= 1500g (3.3 lbs) or \<500g
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraventricular hemorrhage | During NICU admission up to 6 months | Neonates will be followed for up to 6-months during NICU admission to assess for the development of intraventricular hemorrhage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin and hematocrit | During NICU admission up to 6 months | Neonates will be followed for up to 6-months and initial H/H will be recorded. |
| Need for blood transfusion | During NICU admission up to 6 months | Neonates will be followed for up to 6-months and assessed for clinical or laboratory evidence of need for transfusion. |
| Bilirubin levels | During NICU admission up to 6 months | Neonates will be followed for up to 6-months and assessed for clinical jaundice. |
| Delivery room temperature | Delivery | Neonates will be assessed for hypothermia at the time of delivery. |
Countries
United States
Outcome results
None listed