Clinical trial NCT01222364: Delayed Cord Clamping in VLBW Infants
Official title: Delayed Cord Clamping in VLBW Infants Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature
Keywords: NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Very Low Birth Weight (VLBW)
Prematurity
Lead sponsor: NICHD Neonatal Research Network
Sponsor class: NETWORK
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2010-10-18
Enrollment: 54
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding the newborn approximately 10 inches below the birth canal would result in increased hematocrit at 4 hours of age.

Detailed description: This study tested the hypothesis that delaying clamping of the umbilical cord in extremely low birthweight (ELBW) infants would result in additional blood transfusion from the placenta to the baby, increasing the infant's blood volume and blood pressure. Higher blood pressure may improve blood flow to the brain that may reduce potential the risk of hypoxic ischemic encephalopathy (HIE) and/or intraventricular hemorrhage (IVH). The additional placental flow may also increase the amount of stem cells and cytokines flowing to the baby, improving immune status and reducing the risk of infection, while at the same time reducing the need for blood transfusions in the neonatal period.

This was a pilot study to test the feasibility of having obstetricians delay cord clamping for 30-45 seconds, and to confirm whether the procedure significantly increases the baby's hematocrit during the first 4 hours of life.

Eligibility criteria: Inclusion Criteria:

* Infants born at participating centers at 24-27 weeks gestation
* Singletons
* Obstetrician approval for enrollment
* Parental consent

Exclusion Criteria:

* Prenatally diagnosed major congenital anomalies
* Intent to withhold or withdraw care
* Significant bleeding due to placenta previa or abruption

Primary outcomes:
measure: Infants enrolled
timeFrame: 6 months
Secondary outcomes:
measure: Intention to treat
timeFrame: 6 months
measure: Hematocrit level
timeFrame: 4 hours of age
measure: Arterial blood pressure
timeFrame: 12 hours of age
measure: Use of volume expansion or pressor therapy
timeFrame: 24 hours of age
measure: Blood transfusions
timeFrame: Until hospital discharge or 120 days of life
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University, Rainbow Babies and Children's Hospital
state: Ohio
city: Providence
country: United States
facility: Brown University, Women & Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Brown University, Women & Infants Hospital of Rhode Island
name: William Oh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University, Rainbow Babies and Children's Hospital
name: Avroy A. Fanaroff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Edward F. Donovan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Waldemar A. Carlo, MD
role: PRINCIPAL_INVESTIGATOR
References: