Brain Injury Clinical Trial
Official title:
Indomethacin and Delayed Umbilical Cord Clamp for Preterm Infant IVH
Verified date | October 2021 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are brain lesions that commonly occur in preterm infants and are well-recognized major contributors to long-term brain injury and related disabilities later in life. Despite its prevalence, long term consequences, and enormous medical and social costs, mechanisms of IVH and optimal strategies to prevent or treat its occurrence are poorly defined, especially for extremely premature infants. Only one medical therapy, prophylactic indomethacin during the first 3 days of life, has been shown to prevent or decrease the severity of IVH in preterm infants, but its use is limited by toxic side effects and debatable effects on long-term outcomes. Several small studies and case reports suggest that delayed umbilical cord-clamping (DCC) may also decrease the incidence of IVH in premature infants, but thus far these trials have indomethacin treatment mixed within their cord clamping protocols. The investigators are conducting a randomized, blinded investigation of 4 treatment groups: 1) Control (no intervention); 2) DCC alone; 3) Prophylactic indomethacin alone; 4) Combination of DCC/indomethacin, with respect to survival, IVH or PVL incidence and severity, neurodevelopmental outcomes, and relevant mechanistic effects. With the steady rise in extreme prematurity births and clear links of IVH to long-term disabilities there is a need to improve care for these patients. This multi- disciplinary project addresses an important medical problem for an understudied patient population, where the current practice has clear limitations.
Status | Completed |
Enrollment | 256 |
Est. completion date | August 28, 2021 |
Est. primary completion date | October 27, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 24 Weeks to 30 Weeks |
Eligibility | Inclusion Criteria: - pregnant women admitted >24weeks and <30weeks gestational age, - in-hospital birth (allowing for cord clamp randomization) Exclusion Criteria: - preterm infant <24weeks or >30weeks at birth - maternal risks identified by obstetrician - fetal risks identified by obstetrician - any congenital abnormality of newborn infant - placental abruption/placental previa - delivery less than 2hrs from consenting to study participation |
Country | Name | City | State |
---|---|---|---|
United States | Kentucky Childrens Hospital Neonatal Intensive Care Unit | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Hong Huang | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hematological Status | hematocrit, ferritin, hemoglobin at various times during NICU stay | first 60 days of life | |
Other | Inflammatory Stress | measurement of inflammatory biomarkers (CRP, Interleukin-6, soluble ICAM) at various times during NICU stay | first 60 days of life | |
Other | Circulating Progenitor Cell Subpopulations | measures of several progenitor cell subtypes in blood during the NICU stay | first 60 days of life | |
Other | Neurocognitive Assessments at Post-NICU Followup | standardized neurocognitive assessments done at NICU graduate clinic. | up to 24 months of corrected gestational age | |
Primary | Percent of Survivors With no Severe IVH (Grades 3 or 4) or PVL | determined by head ultrasound in Neonatal Intensive Care Unit (NICU) and single head MRI at 38weeks corrected gestational age | within first 60 days of life | |
Secondary | Number of Participants With Acute Kidney Injury | measures of serum creatinine and urine output during Neonatal Intensive Care Unit (NICU) stay. General measures of renal injury (which is a common risk of indomethacin treatment in this patient population). | first 60 days of life |
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