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Neonatal Seizures clinical trials

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NCT ID: NCT05079971 Recruiting - Neonatal Seizures Clinical Trials

EAGLET: EEG vs aEEG to Improve the Diagnosis of neonataL Seizures and Epilepsy

EAGLET
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

The current project undertakes a prospective multicentre randomised controlled trial to evaluate whether full or continuous electroencephalography (cEEG) is superior to amplitude-integrated electroencephalography (aEEG) in the real time evaluation and diagnosis of neonatal seizures and in reducing time to treatment. At-risk new-born infants will be recruited on the participating neonatal intensive care units (NICUs) by trained specialist staff and will have 24 hours of EEG monitoring.

NCT ID: NCT03107507 Recruiting - Neonatal Seizures Clinical Trials

Efficacy of Levetiracetam in Control of Neonatal Seizures Guided by an EEG

Start date: March 25, 2017
Phase: Phase 4
Study type: Interventional

Over the last three decades, several tools have been developed to enhance the detection and treatment of neonatal seizures. Regarding treatment, phenobarbital maintains is still used as a first-line therapy worldwide. However, newer anti-epileptic drugs (AED) s such as, levetiracetam, bumetanide, and topiramate are increasingly being applied to the neonatal population, offering the potential for seizure treatment with a significantly better side-effect profile. Levetiracetam is a very promising medication for the treatment of neonatal seizures. It has been in clinical use for almost a decade in adults and older children with good efficacy, an excellent safety profile and near ideal pharmacokinetic characteristics. It has been approved and used for treatment of seizures in infants starting one month of age since 2012. The investigators are comparing the efficacy of levetiracetam to that of phenobarbital as a first-line drug in control of neonatal seizures. The investigators monitor the efficacy through assessment of frequency of seizures before and after drug administration, amplitude integrated EEG changes in background activity and seizure frequency in participants, duration taken for participants to be seizure free and short term neurodevelopmental outcome and EEG at 3 months of age

NCT ID: NCT02789176 Completed - Neonatal Seizures Clinical Trials

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

Start date: October 2016
Phase:
Study type: Observational

The purpose of this study is to examine whether the duration of treatment with phenobarbital has an impact on neurodevelopmental and epilepsy outcomes, as well as parent and family well-being, after neonatal seizures.

NCT ID: NCT02602015 Not yet recruiting - Neonatal Seizures Clinical Trials

Levetiracetam Treatment of Neonatal Seizures

Start date: November 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This project aims to improve the treatment of neonatal seizures. Current treatments are poorly effective and have significant side effects. Levetiracetam has great potential as a treatment for neonatal seizures but is not approved for use in children less than 1 years of age by oral. This study aims to obtain essential data regarding the efficacy and safety of oral Levetiracetam in neonatal population and simultaneously to use EEG monitoring systems that facilitate seizure detection and research.

NCT ID: NCT02550028 Terminated - Neonatal Seizures Clinical Trials

Levetiracetam Treatment of Neonatal Seizures

Start date: September 1, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory. A multi-centre Chinese clinical trials with the aim to using oral Levetiracetam to develop new treatment strategies for the treatment of neonatal seizures. The purpose of this study is to determine the correct oral dosing, safety and efficacy for oral Levetiracetam as first line treatment in term new born babies with seizures.

NCT ID: NCT02229123 Completed - Neonatal Seizures Clinical Trials

Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study

LEVNEONAT-1
Start date: February 27, 2018
Phase: Phase 2
Study type: Interventional

LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment strategies for the treatment of neonatal seizures using Levetiracetam. The purpose of this study is to determine the correct dosing, safety and efficacy for intravenous levetiracetam as first line treatment in term newborn babies with seizures in hypoxic-ischemic encephalopathy context. This new anticonvulsivant drug is a promising treatment for seizures in newborns.

NCT ID: NCT02160171 Completed - Neonatal Seizures Clinical Trials

ANSeR- The Algorithm for Neonatal Seizure Recognition Study

ANSeR
Start date: April 2013
Phase: N/A
Study type: Observational

A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection: ANSeR

NCT ID: NCT01720667 Completed - Neonatal Seizures Clinical Trials

Efficacy of Intravenous Levetiracetam in Neonatal Seizures

NEOLEV2
Start date: March 2013
Phase: Phase 1/Phase 2
Study type: Interventional

A new anticonvulsant, levetiracetam will be studied to treat seizures in newborn infants. Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory. Monitoring for seizure detection will be tested at five (5) US sites and one (1) international site using the internet.

NCT ID: NCT01475656 Terminated - Neonatal Seizures Clinical Trials

Efficacy of Keppra for Neonatal Seizures

Start date: November 2011
Phase: N/A
Study type: Observational

The purpose of this research study is to learn how well the medication levetiracetam (Keppra) works to treat seizures in full term and premature babies. Levetiracetam is commonly used in babies with seizures at Cincinnati Children's Hospital, especially if the seizures have not been stopped by other medicines. The Food and Drug Administration (FDA) has approved the use of levetiracetam for older children (over the age of 4) but not for infants. Even though it is not FDA approved for this age group, doctors at Cincinnati Children's use the medicine as a second drug in babies whose seizures are not stopped by phenobarbital. Some doctors are concerned that phenobarbital is not the best medicine to treat seizures in babies, so researchers are trying to study other medicines. In this study, the investigators are looking at how well levetiracetam stops or slows down seizures in babies. The investigators are also studying the blood levels of levetiracetam to learn more about how the medicine is processed by the body and what level of medicine in the body works to stop seizures. The investigators are checking labs before and after giving the dose to make sure the medication does not cause any changes in blood counts, kidney function, or liver function. The investigators are following all of the babies in the study after hospital discharge to see if the parents notice any side effects of the medication. Babies in the study will come back to the High Risk Follow Up Clinic at Cincinnati Children's at 6 months of age for a visit with a neurologist and a neonatologist and developmental testing.

NCT ID: NCT01434225 Completed - Neonatal Seizures Clinical Trials

NEMO1:NEonatal Seizure Using Medication Off-patent

NEMO1
Start date: August 2011
Phase: Phase 1/Phase 2
Study type: Interventional

NEMO is a multicentre pan European clinical trial with the aim to develop new treatment strategies for the treatment of neonatal seizures using the loop diuretic bumetanide. There is evidence that bumetanide improves GABAergic function of the current standard drug, phenobarbitone. Bumetanide has been used as a diuretic in term and preterm babies for around thirty years. This trial should confirm that Bumetanide in addition to standard treatment will result in better seizures control.