Delayed Cord Clamping and Infant Brain Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-01

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Iron Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized trial (with a preference arm)

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immediate Cord Clamping (ICC)

The infant will be placed on the maternal abdomen and the umbilical cord will be clamped immediately after birth (routine care).

Group Type NO_INTERVENTION

No interventions assigned to this group

Delayed Cord Clamping (DCC)

At birth, infants will be placed on the maternal abdomen and the cord clamping will be delayed for 5 minutes. If the provider is unable to delay the cord clamping, the cord will be milked 5 times.

Group Type EXPERIMENTAL

Delayed Cord Clamping

Intervention Type PROCEDURE

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.

Interventions

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Delayed Cord Clamping

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.

Intervention Type PROCEDURE

Other Intervention Names

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delayed umbilical cord clamping

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes