Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury

• Status: Active, not recruiting
• Trial end date: 2021-08-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hong Huang; John Bauer
• Treatments: Indomethacin; Pharmaceutical Solutions

Criteria

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