Delayed Cord Clamping and Infant Brain Study
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Delayed Cord Clamping
Intervention type(s): Procedure
Intervention description(s): At birth, the infant will be placed on the maternal abdomen and the umbilical will either be cut immediately or after a 5 minute delay.
Other intervention name(s): delayed umbilical cord clamping
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized trial (with a preference arm)
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: cord clamping (delayed or immediate); Myelin content; Ferritin