Análisis de artículo: impacto técnica aplicación de surfactante mínimamente invasiva. (Impact of minimally invasive surfactant therapy in preterm newborns 28-32 weeks. Peter Dargaville) Revisión realizada por Dr. Gelacio Jiménez Blanco

1. Sesión bibliográfica
Gelacio Jiménez Blanco

2. Título
(a) Indicate the study’s design with a commonly
used term in the title or the abstract
(b) Provide in the abstract an informative and
balanced summary of what was done and what
was found

4. El impacto del la terapia con
surfactante mínimamente invasiva
(MIST) en prematuros de 29 a 32
semanas de gestación

6. Título
(a) Indicate the study’s design with a commonly
used term in the title or the abstract
(b) Provide in the abstract an informative and
balanced summary of what was done and what
was found

7. Introducción
• La presión positiva continua de la vía aérea (CPAP) es una modalidad
de soporte respiratorio recomendada y ampliamente usada en
prematuros de 29 a 32 semanas.
• La mayoria de los recién nacidos tienen suficiente estabilidad
fisiólogica para evitar intubación.
• En algunos pacientes se requiere intubación secundaria y aplicación
de surfactante a pesar de uso óptimo de CPAP.

8. • La intubación y uso de surfactante se asocia con mayor riesgo de
eventos adversos. En especial neumotórax.
• Se han desarrollado técnicas de adminsitración de surfactante menos
invasivas para reducir estos eventos adversos (MIST).

9. Shim G-H. Update of minimally invasive surfactant therapy. Korean Journal of Pediatrics. 2017;60(9):273-281.
doi:10.3345/kjp.2017.60.9.273.

10. • Ensayos aleatorizados controlados, han demostrado algunas ventajas
de esta técnica comparada con la intubación. La mayoría de los
estudios han sido con menores de 29 semanas.
• En los RN 29-32 semanas una menor proporción requerirán
administración de surfactante.
• Estudios observacionales describen que la proporción de recién
nacidos mayores a 29 semanas que reciben surfactante por MIST es
menor.

11. • En este estudio se reporta el impacto del surfactante administrado
por catéter delgado de manera selectiva a las 29-32 semanas de
gestación.
• Examinar si se reducen los episodios de intubación, neumotórax y
otros eventos adversos
• Documentar con mayor extensión la aplicabilidad del procedimiento
en esta edad gestacional, así como los efectos en la oxigenación y
desenlaces.

12. Introducción
Background/rationale Explain the scientific background and
rationale for the investigation being
reported
Objectives State specific objectives, including any
prespecified hypotheses

13. Metodología
• Observacional
• Retrospectivo
• Lugar: Unidad de cuidados intensivos y pediátricos del Hospital Real
Hobart (R.H.H.)
• En dos periodos diferentes de tiempo
• Anidado a las guías de manejo locales para los prematuros de 29-32
semanas
• Evitar intubación en sala de parto (excepto para reanimación avanzada).
• CPAP primera linea de tratamiento para SDR.
• Uso selectivo de caféína, antibioticos y adyuvantes terapéuticos.

14. Grupos de estudio
• RN nacidos en el sur de Tasmania de 29 0/7 a 32 6/7 SDG
• Soporte respiratorio durante las primeras 24 horas de vida
• Examinados durante dos periodos de tiempo
• Época 1: enero 2004 a febrero 2009 inclusiva (50 meses)
• Época 2: marzo 2009 a diciembre 2015 inclusiva (82 meses)
• Se administró surfactante mediante el método “Hobart”
• Uso de MIST como parte de un estudio prospectivo “open label” aprobado por el
comité de ética
• Exclusión:
• Traslados
• RPM mayor de 14 días
• Malformacion congénita mayor que afectara función o manejo respiratorio

15. Método “Hobart”
‘A 16 gauge, 130 mm vascular catheter (16G Angiocath, BD, Sandy, Utah, USA) was marked to
indicate desired depth of insertion (25–26 weeks: 1 cm, 27–28 weeks: 1.5 cm, 29–32 weeks: 2 cm).
Direct laryngoscopy was performed, the tracheal catheter was inserted beyond the vocal cords to
the required depth, and held in position at lips. If catheterisation of the trachea was not possible
within 20–30 s, CPAP was briefly reinstituted followed by a further attempt.
Once the catheter was correctly positioned, surfactant (Curosurf, Chiesi Farmaceutici, Parma, Italy)
was given at a dose of 100 or 200 mg/kg, with the 200 mg/kg dose opted for in 25–28-week infants
in the latter part of the study to discern whether there may be any potential benefit compared with
100 mg/kg dosing. The tracheal catheter was immediately withdrawn, and CPAP recommenced.
Positive pressure inflations were given by mask if the infant was apnoeic or bradycardic.
Modifications made to the MIST technique during the course of the study included retaining the
CPAP prongs in situ throughout the procedure, and delivery of the surfactant as 3–4 boluses over 15–
30 s (rather than more rapidly). Some operators fashioned a slight curvature in the catheter prior to
use.’
Dargaville PA, Aiyappan A, De Paoli AG, et al. Arch Dis Child Fetal Neonatal Ed
2013;98: F122–F126.

16. Recolección de resultados
• Se recolectaron datos demográficos, clínicos, así como también de recursos
y duración de soporte ventilatorio y estancia hospitalaria.
• Se registraron casos de neumotórax, muerte, displasia broncopulmonar,
HIV grado III y IV.
• Las variables dicotómicas se reportan como n(%) y las variables continuas
se reportan como mediana con rangos IQ o media con D.E. Si cumplían con
distribución normal.
• La comparación entre épocas se realizó usando χ2 o la prueba exacta de
fisher para variables dicotómicas. Se usó la prueba Mann-Whitney para
datos continuos.

17. Metodología
Study design Present key elements of study design early in the paper
Setting Describe the setting, locations, and relevant dates, including periods of recruitment,
exposure, follow-up, and data collection
Participants (a) Cohort study—Give the eligibility criteria, and the sources and methods of selection
of participants. Describe methods of follow-up
Case-control study—Give the eligibility criteria, and the sources and methods of case
ascertainment and control selection. Give the rationale for the choice of cases and
controls
Cross-sectional study—Give the eligibility criteria, and the sources and methods of
selection of participants
(b) Cohort study—For matched studies, give matching criteria and number of exposed
and unexposed
Case-control study—For matched studies, give matching criteria and the number of
controls per case
Variables Clearly define all outcomes, exposures, predictors, potential confounders, and effect
modifiers. Give diagnostic criteria, if applicable

18. Metodología
Data sources/
measurement
For each variable of interest, give sources of data and details of methods of assessment (measurement).
Describe comparability of assessment methods if there is more than one group
Bias Describe any efforts to address potential sources of bias
Study size Explain how the study size was arrived at
Quantitative
variables
Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings
were chosen and why
Statistical
methods
(a) Describe all statistical methods, including those used to control for confounding
(b) Describe any methods used to examine subgroups and interactions
(c) Explain how missing data were addressed
(d) Cohort study—If applicable, explain how loss to follow-up was addressed
Case-control study—If applicable, explain how matching of cases and controls was addressed
Cross-sectional study—If applicable, describe analytical methods taking account of sampling strategy
(e) Describe any sensitivity analyses

19. Resultados

25. Resultados
Participants (a) Report numbers of individuals at each stage of study—eg numbers
potentially eligible, examined for eligibility, confirmed eligible,
included in the study, completing follow-up, and analysed
(b) Give reasons for non-participation at each stage
(c) Consider use of a flow diagram
Descriptive
data
(a) Give characteristics of study participants (eg demographic, clinical,
social) and information on exposures and potential confounders
(b) Indicate number of participants with missing data for each variable
of interest
(c) Cohort study—Summarise follow-up time (eg, average and total
amount)

26. Resultados
Outcome
data
Cohort study—Report numbers of outcome events or summary measures over
time
Case-control study—Report numbers in each exposure category, or summary
measures of exposure
Cross-sectional study—Report numbers of outcome events or summary
measures
Main results (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates
and their precision (eg, 95% confidence interval). Make clear which confounders
were adjusted for and why they were included
(b) Report category boundaries when continuous variables were categorized
(c) If relevant, consider translating estimates of relative risk into absolute risk for a
meaningful time period
Other
analyses
Report other analyses done—eg analyses of subgroups and interactions, and
sensitivity analyses

27. Discusión
• Contiene limitantes impuestas por la no aleatorizacion, diseño
retrospectivo.
• *La disminución de neumotórax en la época 2, es plausible que esté
relacionada a la introducción de MIST.
• Puede haber influencia por incremento de esteroides antenatales en
época 2
• La técnica en estudio se aplico a una minoría de pacientes

28. Discusión
Key results Summarise key results with reference to study objectives
Limitations Discuss limitations of the study, taking into account sources of potential bias or
imprecision. Discuss both direction and magnitude of any potential bias
Interpretation Give a cautious overall interpretation of results considering objectives, limitations,
multiplicity of analyses, results from similar studies, and other relevant evidence
Generalisability Discuss the generalisability (external validity) of the study results
Other
information:
Funding
(Give the source of funding and the role of the funders for the present study and, if
applicable, for the original study on which the present article is based