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

Study Overview
=================
Brief 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.

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 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.

Official Title
-----------------
Protective Effects of Delayed Cord Clamping in VLBW Infants

Conditions
-----------------
Intraventricular Hemorrhage, Sepsis

Intervention / Treatment
-----------------
* Procedure: delayed umbilical cord clamping
* Other: Immediate cord clamping


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1-Delayed Cord Clamping (DCC)<br>Immediately after birth, the infant is placed in a warm blanket and held lower than the placenta. The research nurse counts out 30 to 45 seconds for the obstetrician. The cord is milked once and then clamped at 30 to 45 seconds after birth. | Procedure: delayed umbilical cord clamping<br>* 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.<br>* Other names: cord milking;|
| Active Comparator: 2-Immediate Cord Clamping (ICC)<br>Routine care which is immediate cord clamping | Other: Immediate cord clamping<br>* The umbilical cord is cut within 10 seconds after birth<br>* Other names: routine care;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VLBW infants in the DCC group will have better motor function at 7 months corrected age |  | November 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraventricular hemorrhage, sepsis, motor function, motor functioning at 7 months corrected age, cytokines in cord blood and at 6 and 20 hours of age, stem cells in cord blood and at 20 hours of age