Growth and Intelligence Outcome in Children Who Developed Perioperative Desaturation

NCT01965093 | Completed DMC

• 1 other identifier: IQ208
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The most serious peri-operative respiratory event (PRE) in pediatric anesthesia is desaturation or hypoxemia which could lead to cardiovascular collapse or cardiac arrest. Intermittent hypoxic episode especially in infants are also associated with impaired growth, longer-term cardiorespiratory instability and poor neurodevelopmental outcome.12 The mechanism of peri-operative desaturation occurring in normoxia infant brain is quite similar to overabundance of oxygen in the acutely hypoxic infant by using 100% oxygen or hyperoxia for resuscitation of acutely asphyxiated infants which can generate excessive neurotoxic compounds and increase oxidative stress markers.17 Anesthetic agents which involve gamma-aminobutyric acid (GABA)receptors eg; volatile agents, midazolam and N-methyl-D-aspartate receptor (NMDA) receptors eg; nitrous oxide, ketamine can cause neuronal apoptosis, neuronal necrosis, neuronal cell death and memory deficit in rat pups. Moreover, prolonged anesthetic exposure, irrespective of open heart surgery, can influence neurodevelopment of the brain in rodents.17 However, the evidence for anesthetic agents causing apoptosis and neurodegeneration in human neonatal brain is still not clear. Thus, peri-operative desaturation occurred in young age regardless of severity combined with general anesthesia might possibly affect the long-term impact regarding growth and neurodevelopmental outcome in infant or intelligence outcome in older children. In our study, we are interested in looking at the intelligence outcome, which is a part of neurodevelopment outcome, in preschool children aged ≤ 5 years who developed desaturation peri-operatively. Because we include a wide range of age between newborn to five years old to test neurodevelopment outcome in older children, the intelligence outcome may be more appropriate and can be applied to infants and younger ages. Therefore, the objective of study was to compare intelligence outcome between children who developed peri-operative desaturation and children who did not develop PRE.

Conditions

Low IQ; Disorder of Growth and Development

Keywords

perioperative; desaturation; growth development; intelligence outcome

Outcome Measures

Primary Outcomes (1)

• Intelligence outcome

  IQ score either Standford Binet-LM or WIS III

  2 to 8 years old

Secondary Outcomes (1)

• Growth development

  2 to 8 years old

Other Outcomes (2)

• percentile height

  age 2 - 8 years old

• percentile weight

  age 2-8 years old

Study Arms (2)

perioperative desaturation

children aged 0-5 years who received general anesthesia and developed perioperative desaturation

Procedure: perioperative desaturation

no perioperative desaturation

children aged 0-5 years who received general anesthesia and did not developed perioperative desaturation

Procedure: no perioperative desaturation

Interventions

perioperative desaturation PROCEDURE

children aged 0-5 years old who receive general anesthesia and developed perioperative desaturation

perioperative desaturation

no perioperative desaturation PROCEDURE

children aged 0-5 years who did not developed perioperative desaturation under general anesthesia

no perioperative desaturation

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children aged 0-5 years who receive general anesthesia at Songklanajarind Hospital between 2008-2011

You may qualify if:

• Children aged ≤ 5 years old who received general anesthesia and developed intraoperative or post-anesthetic care unit (PACU) desaturation between 2008 and 2011 were included in the study and was defined as desaturation group.

Sponsors & Collaborators

• Prince of Songkla University: lead
• The Royal Golden Jubilee PhD funding of Thailand: collaborator

Study Sites (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90112, Thailand

Location

Study Officials

• Maliwan Oofuvong, MD

  Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 18, 2013
• Study Start: November 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 18, 2013

Record last verified: 2013-10

Locations

TH (1)