AEEG in Pre-term Infants

NCT04008498 | Completed

• 1 other identifier: STH19716
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Amplitude integrated encephalography (aEEG) is a monitor that measures brain activity by attaching leads to a baby's head, and is used routinely in term babies who have brain injury because of a difficult birth. There is little information on how useful aEEG is in premature babies, and most studies only look at small numbers of babies. However, these studies suggest that the aEEG is different in premature babies with brain injury, infections / meningitis, and in those receiving certain drugs. It is also affected by changes in blood pressure and blood acid levels. It is theoretically possible that, if the investigators can detect changes using aEEG early on, the investigators will be able adjust treatment to make a baby better.

Conditions

Preterm Infant

Outcome Measures

Primary Outcomes (2)

• Recruitment Rate

  This is a feasibility study to inform the design of a larger multi-centre study. Rate of recruitment will determine how many centre's required for a larger study. Amount of time required to reach recruitment targets will inform average recruitment rate.

  Upto 24 months after recruitment

• Optimal Timing For AEEG Recording

  This is a feasibility study to inform the design of a larger multi-centre study. The results of full AEEG recordings will demonstrate important time points to be recorded for larger study. Time points of abnormal brain activity will be measured and recorded.

  Upto 24 months after recruitment

Study Arms (1)

AEEG monitoring

EXPERIMENTAL

Babies whose families consent to involvement will have their head cleaned, EEG leads attached, the monitor set up, and observations. Babies will be recorded continuously for the entire duration of their time on the intensive care unit. Once the child is receiving high dependency or special care, the investigators will record aEEG for 4 hours once a week until the baby is discharged home. If a participant is moved back to intensive care, the aEEG will be started again if the aEEG monitor is not being used on another baby. Before being discharged home, the babies will have additional follow-up. They will receive magnetic resonance imaging (MRI) of the brain on a 1.5T scanner at the University of Sheffield. They will also have a standardised examination of their neurological system performed by a physiotherapist (The Hammersmith Neonatal Neurological Examination).

Diagnostic Test: AEEG brain monitoring

Interventions

AEEG brain monitoring DIAGNOSTIC_TEST

Babies will be recorded continuously for the entire duration of their time on the intensive care unit. Once the child is receiving high dependency or special care, we will record aEEG for 4 hours once a week until the baby is discharged home. If a participant is moved back to intensive care, the aEEG will be started again if the aEEG monitor is not being used on another baby.

AEEG monitoring

Eligibility Criteria

• Age: 26 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants between 26+0 and 30+0 weeks gestational age
• Requiring intensive care following birth
• Live in Sheffield catchment area
• English speaking
• No skin viability issues on the head
• Study aEEG monitor available for use
• No known genetic, congenital structural brain abnormality, congenital infection, metabolic condition or other disorder likely to impact on neurological function independent of preterm birth

You may not qualify if:

• Under 26+0 gestational age
• Known genetic, congenital structural brain abnormality, congenital infection, metabolic condition or other disorder likely to impact on neurological function independent of preterm birth
• Non-English speakers
• Non consent

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Jessop Wing

Sheffield, South Yorkshire, S10 2SF, United Kingdom

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: July 5, 2019
• Study Start: May 30, 2018
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)