Newborn Brain Society

Active Trials

Active Clinical Trials and Studies in Neonatal Neurology/Neurocritical Care:

Active Trials/Studies

Neonatal Seizure Registry – Developmental Functional Evaluation (NSR-DEV)

NCT: NCT04337697, 1st posted 2020

This study will maintain a unique cohort of children who survived acute symptomatic neonatal seizures for school-aged development, epilepsy, and parent well-being outcomes. The study is designed to enable (1) robust modeling of early risk factors for persistent disability in childhood, (2) novel clinical prediction rules, (3) potentially modifiable risk factors related to parent well-being, and (4) essential data to plan rigorous, high impact parent and infant interventions, as well as foundational trials of anti-epileptogenic and neuroprotective agents.

TIME (Therapeutic Hypothermia for Infants With Mild Encephalopathy)
NCT: NCT04176471, 1st posted 2019
The TIME study is a California based multi-center randomized, controlled trial of Therapeutic Hypothermia (TH) (33.5°C ± 0.5° for 72 hours) versus normothermia in term neonates with Mild Hypoxic-Ischemic Encephalopathy (HIE). The primary outcome is neurodevelopmental outcome at 12-14 months of age.
Status: Not yet recruiting

SafeBoosC-III (Safeguarding the Brain of Our Smallest Infants)

NCT: NCT03770741, 1st posted 2018

Randomized trial of standard care vs. NIRS-based care of VLBW infants in the first 72h after birth.  Infants receive standardized interventions when cerebral NIRS falls below threshold.  Primary outcome is death or severe brain injury on cranial ultrasound.  Goal recruitment of 1600 infants.

Status: Open to enrollment

COMET (Optimising the Duration of Cooling in Mild Encephalopathy)
NCT: NCT03409770, 1st posted 2018
This is a feasibility phase II randomised controlled trial to identify the ‘optimal cooling duration’ and seeks to examine the feasibility of recruiting and randomising babies with mild neonatal encephalopathy to multiple treatment durations and the feasibility of obtaining adequate quality data on the primary outcome for the phase II trial (i.e. thalamic N-acetylaspartate concentration). A total of 32 babies with mild neonatal encephalopathy will be recruited in the UK over a one year period cooling for one of three durations: 24h, 48h, or 72h with MRI/MRS primary outcome. Status: Open to enrollment

MEND (Mild Encephalopathy in the Newborn Treated With Darbepoetin)

NCT: NCT03071861, 1st posted 2017

This is a Phase II multicenter placebo-controlled randomized, feasibility/safety trial. Infants >34 week gestational age with perinatal acidemia and mild neonatal encephalopathy on the modified Sarnat will be randomized to receive either one dose of Darbepoetin, or placebo within 24 hours of birth. Neurodevelopmental testing (Bayley III and Gross Motor Function Assessment) will be performed at 8-12 months of age.

Status: Closed to new enrollment, ongoing.

HEAL (High-dose Erythropoietin for Asphyxia and Encephalopathy)

NCT: NCT02811263, 1st posted 2016

RCT of HIE infants receiving placebo or high-dose Epo for neuroprotection in moderate to severe HIE.  Goal recruitment of 500 infants.  Primary outcome is death or cognitive/motor deficits at 2 years of age.

Status: Closed to new enrollment, ongoing

Continued Anticonvulsants After Resolution of Neonatal Seizures: a Patient-centered Comparative Effectiveness Study

NCT: NCT02789176, 1st posted 2016

Observational comparative effectiveness study of discontinuation versus maintenance of antiseizure medication upon hospital discharge after acute symptomatic neonatal seizures. Primary outcomes include functional development and post-neonatal epilepsy at age 24 months (under review), as well as parent well-being measures

Preemie Hypothermia for Neonatal Encephalopathy

NCT: NCT01793129, 1st posted 2013

This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). This is a Randomized Trial of Targeted Temperature Management With Whole Body Hypothermia at 18 NICHD Neonatal Research Network sites to either receive TH or non-cooled control group.

Status: Open to enrollment.