The GAS study, A multi-site, randomized controlled trial comparing regional and general anesthesia for effects on neurodevelopmental outcome and apnea in infants.

Study ID
STU 082010-312

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Roxana Ploski
214-456-8559
roxana.ploski@utsouthwestern.edu

Principal Investigator
Peter Szmuk

Summary

any infants of postmenstrual age 60 weeks age or less scheduled for unilateral or bilateral inguinal hernia repair with or without circumcision will be potential candidates for the study. a total of 720 subjects will be enrolled worldwide in centers from united States, united Kingdom, australia, Canada, and italy. Locally, a total of 20 subjects will be enrolled.

Prospective subjects will be identified from the operating room schedule and will be asked to participate after agreement from their surgeon. once informed consent is obtained by a study team member, participants will be randomized to either the General anesthesia group (Ga) or to the awake Regional anesthesia group (Ra). Parents will then be administered the PeDS:DM assessment to acheive a baseline developmental status for each subject. The PeDS:DM may also be administered during the 5 day follow up call.
Data regarding participants medical and social history, current surgical and anesthesia procedure, medication, vital signs (VS), and any complications will be collected at screening and some continuously collated throughout the study. Subjects will undergo surgery and have anesthesia as indicated by the randomization process. after surgery, subjects VS, signs of apnea and/or stridor, medication administered, time of first feed and time of discharge will be monitored and documented.

in the period from 1-5 days post anesthesia, data regarding medication, medical interventions, occurrence of infection associated with nerve blockage, occurrence of stridor, discharge, and/or readmission to the hospital may be collected. if the child stays in the hospital longer than 5 days, the length of stay in hospital and details of any medical intervention in the period between surgery and discharge from hospital will be collected.
Subjects will be followed for a total period of 5 years. Study visits after surgery and discharge will only take place at 2 years and at 5 years of age. During this visit data regarding medication, medical history and patient family information will be collected as per protocol. This includes data on family and environmental factors, development and care arrangements. it is during the study visits that neurodevelopmental assessments will also be performed. Subjects' participation in the study will end after the 5 year visit.

Participant Eligibility


* Are scheduled for unilateral or bilateral inguinal hernia repair (with or without circumcision).

* Have a Gestational Age, 26 weeks or more (GA >= 182 days)

* Have a Postmenstrual Age, up to 60 weeks (PMA ≤ 426 days)