Neurological risk factors in infants having non-cardiac surgery, and their relationship to growth and neurodevelopmental outcome

A non-randomised study assessing the neurological risk factors in infants having non-cardiac surgery, and their relationship to growth and neurodevelopmental outcome.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12610000156088

Enrollment

Registered

2010-02-16

Start date

2011-04-25

Completion date

2013-07-25

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The primary purpose of this study is the examine the cerebral injury and changes in cerebral structure in late preterm and term infants undergoing surgery using neurobehvavioural, electrophysiology and MR imaging. Our study hypothesis is that childhood survivors of infants undergoing surgery in the newborn period for conditions including oesophageal atresia, congenital diaphragmatic hernia and gastroschisis will have impaired neurodevelopment.

Interventions

Assessment will be with a combination of neurobehavioural assessment, amplitude integated electroencephalography (aEEG) and magnetic resonance imaging (MRI). Neurobehavioural assessment will be conducted by the Bayley III at 1 year and 2 years corrected gestational age. This assessment takes approximately two hours. MRI will be acquired at two time points- pre-operatively and post-operatively. Participants will have aEEG placed in the post-operative period. The type of surgery that the participa

Eligibility

Sex/Gender

All

Age

1 Days to 1 Months

Healthy volunteers

Inclusion criteria

All infants born after 31 completed weeks gestation with either congenital diaphragmatic hernia, oesophageal atresia or anterior abdominal wall defect.

Exclusion criteria

None.

Outcome results