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Clinical Trials/NL-OMON38102
NL-OMON38102
Completed
Phase 4

The effects of anaesthesia on neurodevelopmental outcome and apnoe in infants: the GAS study. - GAS study

niversitair Medisch Centrum Utrecht0 sites40 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
anesthesiologie
Sponsor
niversitair Medisch Centrum Utrecht
Enrollment
40
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Eligibility Criteria

Inclusion Criteria

  • Any infant scheduled for unilateral or bilateral inguinal hernia repair (with or without circumcision)
  • Any infant whose gestational age (GA) is 26 weeks or more
  • Any infant whose post\-menstrual age (PMA) is up to 60 weeks.

Exclusion Criteria

  • 1\. Any child older than 60 weeks post\-menstrual age
  • 2\. Any child born at less than 26 weeks gestation
  • 3\. Any contraindication to general or spinal/caudal anaesthesia (for example: neuromuscular disorder or coagulopathy)
  • 4\. Pre\-operative ventilation immediately prior to surgery
  • 5\. Congenital heart disease that has required surgery or will require surgery or which requires ongoing pharmacotherapy
  • 6\. Known chromosomal abnormality or any other known acquired or congenital abnormalities (apart from prematurity) which are likely to affect development
  • 7\. Children where follow\-up would be difficult for geographic or social reasons
  • 8\. Families where Dutch is not the language spoken at home
  • 9\. Known neurological injury such as cystic periventricular leukomalacia (PVL), or grade 3 or 4 intra\-ventricular haemorrhage (IVH) (\+/\- post\-haemorrhage ventricular dilatation)
  • 10\. Previous exposure to volatile anaesthesia or benzodiazepines as a neonate or in the third trimester in utero

Outcomes

Primary Outcomes

Not specified

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