Delayed Cord Clamping and Infant Brain Study



Status:Active, not recruiting
Conditions:Iron Deficiency Anemia, Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - 45
Updated:10/13/2018
Start Date:October 1, 2012
End Date:December 31, 2018

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Effects of Placental Transfusion on Early Brain Development

The purpose of this study is to determine if delaying cord clamping at the birth of term
infants effects the early brain development (myelin deposition)as determined by quantitative
MRI at 4 and 10 months and developmental testing at 4, 10 and 24 months. This study will help
to establish a scientific basis for the timing of cord clamping with reference to brain
development.

The current obstetrical practice at birth in the United States is that the umbilical cord of
the infant is clamped immediately. When immediate clamping occurs, 20 to 40% of the
fetal-placental blood volume is left behind in the placenta. This blood contains enough
iron-rich red blood cells to meet the infant's iron needs for the first 4 to 6 months of
life. Delaying cord clamping has been shown to increase early iron stores without
contributing to adverse outcomes. Early iron sufficiency is essential for long term
neurologic health. Iron deficiency in infancy adversely affects cognitive, motor,
socio-emotional, and behavioral development. Human and animal studies have shown that
inadequate iron stores in early infancy have an irreversible negative impact on the
developing brain with deficits persisting even after iron levels have been restored by iron
supplementation. Iron is an essential component of myelination which is critical for normal
brain development and function. Myelination, which peaks during the first year of life,
establishes and maintains efficient communication between the discrete regions of the brain.
Abnormal myelination underlies a variety of childhood developmental disorders including
conditions such as autism.

The gap is that the effect of increased iron stores from delayed cord clamping on myelination
and neurodevelopment during early childhood is unknown. Our hypothesis is that placental
transfusion affects myelination and early childhood development in the following ways: 1)
placental transfusions lead to increased blood volume (BV) and red cell volume (RCV) at
birth; 2) increased RCV results in more available iron for early body iron stores; 3)
increased body iron stores provide essential iron supply for optimal myelination; 4) optimal
myelination results in improved developmental and cognitive performance. We propose a
randomized controlled longitudinal (birth to 24 months) trial of 128 infants to measure the
effect of placental transfusion on the structure and function of the developing brain. We
will use a non-invasive neuroimaging technique to measure myelin acquisition over time and to
correlate the findings with iron stores and developmental outcomes. Enrolled women will be
randomized at birth to the immediate cord clamping group or the delayed cord clamping group.
We will assess infants for iron sufficiency and myelin deposition at 4 and 10 months and
evaluate developmental outcomes at 4, 10, and 24 months. This study will help to establish a
scientific basis for the timing of cord clamping with reference to brain development. The
innovation of this study is in the simplicity of delaying cord clamping combined with the use
of a new method of MRI that can quantify myelin deposition. This low-tech change in a
clinical practice has the potential to reduce iron deficiency and improve developmental
outcomes. If delayed cord clamping demonstrates protective effects for optimal development,
changing practice will translate into a large cost savings improving lifetime productivity
beneficial to society as a whole.

Inclusion Criteria:

- women in the third trimester with:

- singleton pregnancy

- planning to breastfeed for six months

- English speaking

- planning vaginal birth

Exclusion Criteria:

- major medical or obstetrical complications

- Intrauterine growth restriction

- chorioamnionitis

- familial learning disability

- major psychiatric or depressive illness

- fetal congenital anomalies
We found this trial at
1
site
101 Dudley St
Providence, Rhode Island 02905
(401) 274-1100
Women and Infants Hospital of Rhode Island Women & Infants Hospital of Rhode Island, a...
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mi
from
Providence, RI
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