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Postdischarge Care of Pediatric Traumatic Brain Injury in Argentina: A Multicenter Randomized Controlled Trial*

Carney, Nancy A. PhD; Petroni, Gustavo J. MD, MCR; Luján, Silvia B. MD; Ballarini, Nicolás M. MS; Faguaga, Gabriela A. MD; du Coudray, Hugo E. M. PhD; Huddleston, Amy E. MPA:HA; Baggio, Gloria M. MD; Becerra, Juan M. MD; Busso, Leonardo O. MD; Dikmen, Sureyya S. PhD; Falcone, Roberto MD; García, Mirta E. MD; González Carrillo, Osvaldo R. MD; Medici, Paula L. MD; Quaglino, Marta B. PhD; Randisi, Carina A. MD; Sáenz, Silvia S. MD; Temkin, Nancy R. PhD; Vanella, Elida E. MD

Pediatric Critical Care Medicine: July 2016 - Volume 17 - Issue 7 - p 658–666
doi: 10.1097/PCC.0000000000000772
Neurocritical Care

Objective: To develop, in partnership with families of children with traumatic brain injury, a postdischarge intervention that is effective, simple, and sustainable.

Design: Randomized Controlled Trial.

Setting: Seven Level 1 Pediatric Trauma Centers in Argentina.

Patients: Persons less than 19 years of age admitted to one of the study hospitals with a diagnosis of severe, moderate, or complicated mild traumatic brain injury and were discharged alive.

Interventions: Patients were randomly assigned to either the intervention or standard care group. A specially trained Community Resource Coordinator was assigned to each family in the intervention group. We hypothesized that children with severe, moderate, and complicated mild traumatic brain injury who received the intervention would have significantly better functional outcomes at 6 months post discharge than those who received standard care. We further hypothesized that there would be a direct correlation between patient outcome and measures of family function.

Measurements and Main Results: The primary outcome measure was a composite measured at 6 months post injury. There were 308 patients included in the study (61% men). Forty-four percent sustained a complicated mild traumatic brain injury, 18% moderate, and 38% severe. Sixty-five percent of the patients were 8 years old or younger, and over 70% were transported to the hospital without ambulance assistance. There was no significant difference between groups on the primary outcome measure. There was a statistically significant correlation between the primary outcome measure and the scores on the Family Impact Module of the Pediatric Quality of Life Inventory (ρ = 0.57; p < 0.0001). Children with better outcomes lived with families reporting better function at 6 months post injury.

Conclusions: Although no significant effect of the intervention was demonstrated, this study represents the first conducted in Latin America that documents the complete course of treatment for pediatric patients with traumatic brain injury spanning hospital transport through hospital care and into the postdischarge setting.

1Oregon Health and Science University, Portland, OR.

2Centro de Informática e Investigación Clínica, Rosario, Argentina.

3Universidad Nacional de Rosario, Rosario, Argentina.

4Hospital de Niños Víctor J Vilela, Rosario, Argentina.

5Department of Psychology, Portland State University, Portland, OR.

6Sistema Integrado de Emergencia Sanitaria, Rosario, Argentina.

7Hospital El Cruce, Florencio Varela, Argentina.

8University of Washington, Seattle, WA.

9Hospital Interzonal Especializado Materno Infantil Dr. Vitorio Tetamanti, Mar del Plata, Argentina.

10Hospital de Niños Sor María Ludovica, La Plata, Argentina.

11Hospital de Niños “Dr. Orlando Alassia”, Santa Fe, Argentina.

12Hospital de Niños de la Santísima Trinidad, Córdoba, Argentina.

13Hospital Pediátrico Dr. Humberto Notti, Mendoza, Argentina.

*See also p. 700.

This project was funded by the Eunice Kennedy Schriber National Institute on Child Health and Human Development, and the Fogarty International Center of the National Institutes of Health (5R01-HD060570).

Following is the name of the institutions where the work was performed: Hospital de Niños Víctor J Vilela, Rosario, Argentina; Hospital de Niños Sor María Ludovica, La Plata, Argentina; Hospital El Cruce, Florencio Varela, Argentina; Hospital de Niños de la Santísima Trinidad, Córdoba, Argentina; Hospital de Niños “Dr. Orlando Alassia”, Santa Fe, Argentina; Hospital Pediátrico Dr. Humberto Notti, Mendoza, Argentina; Hospital Interzonal Materno Infantil Dr. Vitorio Tetamanti, Mar del Plata, Argentina.

Dr. Carney received support for article research from the National Institutes of Health (NIH). Her institution received grant support. Drs. Petroni, Lujan, Ballarini, Faguaga, du Coudray, Huddleston, Baggio, Becerra, Busso, Dikmen, Falcone, Garcíav, González Carrillo, Medici, Quaglino, Randisi, Sáenz, and Vanella received support for article research from the NIH. Their institutions received grant support from NICHD/FIC (grant number 1 R01 HD060570). Dr. Temkin consulted for multiple pharmaceutical companies (DSMB membership, none related to the topic of this paper) and received support for article research from the NIH. Her institution received grant support from NICHD/FIC (Grant number 1 R01 HD060570) and from NIH, DoD, and the CDC (multiple grants, none related the topic of this paper).

For information regarding this article, E-mail: carneyn@ohsu.edu

©2016The Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies