Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Neurology, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/24/2019 |
| Start Date: | August 2014 |
| End Date: | December 2020 |
| Contact: | Peter J Giannone, MD |
| Email: | peter.giannone@uky.edu |
Indomethacin and Delayed Umbilical Cord Clamp for Preterm Infant IVH
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.
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.
The investigators will compare efficacy and safety of prophylactic indomethacin, DCC, and
their combination, in affecting the incidence and severity of IVH/PVL in infants <30wks
gestational age (primary outcome measure of 'fraction of survivors with no severe IVH or PVL'
among the 4 groups), and longer term neurocognitive function. Other secondary endpoints and
investigations include mechanistic effects of prophylactic indomethacin, DCC, and their
combination (blood volume/circulatory status, inflammatory stress, progenitor cells) as well
as defining relationships between clinical outcomes and mechanistic measurements among
treatment groups.
their combination, in affecting the incidence and severity of IVH/PVL in infants <30wks
gestational age (primary outcome measure of 'fraction of survivors with no severe IVH or PVL'
among the 4 groups), and longer term neurocognitive function. Other secondary endpoints and
investigations include mechanistic effects of prophylactic indomethacin, DCC, and their
combination (blood volume/circulatory status, inflammatory stress, progenitor cells) as well
as defining relationships between clinical outcomes and mechanistic measurements among
treatment groups.
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
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