A study of the impact of treating seizures that can be seen and those that can be seen only on a brain monitor in newborn babies, who are having seizures or at high risk of seizures.

A randomised controlled trial comparing the treatment of electrographic seizures and clinical seizures, to the treatment of clinical seizures alone, in term or near-term infants and measuring the impact on death and neurodevelopment at 2 years.

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000327987

Acronym

NEST (Neonatal Electrographic Seizure Trial)

Enrollment

212

Registered

2011-03-28

Start date

2011-09-20

Completion date

2016-02-12

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Doctors know that seizures occur more often in babies than older children. Seizures in babies may result in damage to their brain that may lead to epilepsy or affect their learning, thinking and memory. There is not a lot of research as to the best way to treat seizures in babies and to protect their brain function. The aim of this research project is to compare the treatment of seizures that are physically seen by doctors and nurses (standard clinical care) to when seizures are detected using an amplitude integrated electroencephalograph monitor (aEEG), to see which method is better at protecting brain function in the longer term. We hope a total of 630 babies will take part in this study. Half of the babies will receive standard treatment and half will be treated when a seizure is seen on the aEEG monitor. After the babies have been discharged from hospital we will follow them up at 2 years of age to assess their development. This research project is important because it may change the way doctors treat seizures in babies in the future, and we want to make sure that our treatment is protecting the babies brain.

Interventions

Amplitude integrated electroencephalography monitoring will be applied to consented newborn infants admitted to participating Neonatal Intensive Care Units. Infants will be randomized into two groups: (1) Clinical seizure group (CSG) - infants who will recieve treatment of clinical seizures alone - this is standard treatment (electrographic seizures will not be revealed to the treating physician). (2) Electrographic seizure group (ESG) - infants who will be treated for both clinical and electrographic seizures. Electrographic seizures will be detected by a bedside amplitude integrated EEG (aEEG) monitor. Monitoring will be applied for five days. Treatment of seizures in both groups will follow a strict alogrithim based on current standard practice. Anticonvulsants used will include phenobarbitone, phenytoin and midazolam at standard clinical dosage.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

1 Hours to 48 Hours

Healthy volunteers

Inclusion criteria

Infants greater than or equal to 35 weeks' gestation (term or near term) admitted to a participating Neonatal Intensive Care Unit. Less than or equal to 48 hours old: A diagnosis of either: -Neonatal encephalopathy including coma, stupor or depressed mental state (based on modified Sarnat classification II-III). -Hypoxic-ischaemic encephalopathy or at risk for hypoxic-ischaemic encephalopathy (ie. 2 of the following - Apgar score less than 5 at 5 minutes); cord blood gas or postnatal blood gas within 1 hour of birth with a pH less than 7.1 or base excess < -12 within 1 hour of birth; need for ongoing respiratory support at 10 minutes after birth) -suspected neonatal seizures

Exclusion criteria

Infants less than 35 weeks gestation; Greater than 48 hours old; Infants in non-convulsive status (as confirmed by conventional electroencephalography taken for one hour as soon as practical); Infants diagnosed with Cerebral dysgenesis

Outcome results