Abstract
Very little evidence is available that supports or disproves the use of medications
in neonatal resuscitation. In this randomized controlled trial, we evaluated the effect
of sodium bicarbonate given during neonatal resuscitation, on survival and neurological
outcome at discharge. Subjects and methods: Consecutively born asphyxiated neonates continuing to need positive pressure ventilation
at 5 min of life received either sodium bicarbonate or 5% dextrose. The study group was
given intravenous sodium bicarbonate solution 4 ml/kg (1.8 meq./kg) over 3–5 min. This solution was prepared by diluting 7.5% sodium bicarbonate (0.9 meq./ml) with distilled water in a 1:1 ratio. The placebo group received 4 ml/kg of undiluted 5% dextrose at a similar rate. The surviving neonates were evaluated
for their neurological status at discharge. Primary outcome variable: Death or abnormal neurological examination at discharge. Secondary outcome variables: Encephalopathy, multi-organ dysfunction, intraventricular haemorrhage (IVH) and
arterial pH at 6 h. Results: Twenty-seven babies were randomized to receive sodium bicarbonate (bicarb group)
and 28 to receive 5% dextrose. Eighteen of the 27 (66.7%) babies in the bicarb group
and 19 of the 28 babies (68%) in the dextrose group survived to discharge (P=0.84). Twenty-eight percent of the survivors in the bicarb group and 32% of the survivors
in the dextrose group were neurologically abnormal at discharge (P=0.10). The composite primary outcome of death or abnormal neurological examination
at discharge was similar in both groups (52% versus 54%, P=0.88). The incidence of encephalopathy (74% versus 63%), cerebral oedema (52% versus
30%), need for inotropic support (44% versus 29%), intraventricular haemorrhage (IVH)
and the mean arterial pH at 6hrs were similar between the two groups. Conclusion: Administration of sodium bicarbonate during neonatal resuscitation did not help
to improve survival or immediate neurological outcome.
Sumàrio
Há muito pouca evidência que suporte ou contra-indique o uso de medicamentos em reanimação
neonatal. Neste estudo aleatorizado e controlado, avaliamos o efeito do bicarbonato
de sódio administrado durante reanimação neonatal na sobrevida e no estado neurológico
à data de alta. População e métodos: Administrou-se bicarbonato de sódio ou glicose a 5% a um grupo consecutivo de recém-nascidos
em asfixia que mantinham necessidade de ventilação com pressão positiva aos 5 min
de vida. Ao grupo de estudo foram administrados 4mL/Kg de uma solução de bicarbonato
de sódio intravenoso (1,8 mEq/Kg) durante 3–5 minutos. Esta solução foi preparada
diluindo bicarbonato de sódio a 7,5% (0,9 mEq/mL) em água destilada na razão 1:1.
O grupo placebo recebeu, da mesma forma, 4mL/Kg de glicose a 5% não diluı́da.
Os recém-nascidos sobreviventes foram avaliados neurologicamente à data de alta. Variável de resultado primário: Morte ou exame neurológico anormal à data de alta. Variáveis de resultado secundário: Encefalopatia, disfunção multiorgânica, hemorragia intraventricular (IVH) e pH arterial
às 6 horas. Resultados: Vinte e sete bébés foram aleatorizados para receberem bicarbonato de sódio (grupo
bicarb) e 28 para receberem glicose a 5%. Dezoito dos 27 (66,7%) bébés do grupo bicarb
e 19 dos 28 bébés (68%) do grupo de glicose sobreviveram até à alta (P=0,84). Vinte e oito por cento dos sobreviventes no grupo bicarb e 32% no grupo de
glicose tinham alterações neurológicas à data de alta (P=0,10). O resultado primário composto de morte ou exame neurológico anormal à data
de alta foi semelhante em ambos os grupos (52% versus 54%, P=0,88). A incidência de encefalopatia (74% versus 63%), edema cerebral (52% versus
30%), necessidade de suporte inotrópico (44% versus 29%), hemorragia intraventricular
(IVH) e o pH arterial médio às 6 horas foram semelhantes entre os grupos. Conclusão: A administração de bicarbonato de sódio durante a reanimação neonatal não foi útil
na melhoria da sobrevida ou do resultado neurológico imediato.
Resumen
Existe muy escasa evidencia que apoye o desapruebe el uso de medicamentos en reanimación
neonatal. En este estudio randomizado y controlado, evaluamos el efecto del bicarbonato
de sodio usado durante la reanimación neonatal sobre la sobrevida y el resultado neurológico
al momento del alta. Sujetos y método: Neonatos cosecutivos que nacen con asfixia que siguen necesitando ventilación a
presión positiva después de 5 minutos de vida recibieron bicarbonato o dextrosa 5%.
El grupo de estudio recibió por vı́a venosa solución de bicarbonato de sodio
4 ml/kg (1.8 meg/kg) en 3–5 minutos. Esta solución fue preparada diluyendo bicarbonato al 7.5%
(0.9 meq/kg) con agua destilada en relación 1:1. El grupo placebo recibió 4 mg/kg de dextrosa al 5% sin diluir, a velocidad similar. Los neonatos que sobrevivieron
fueron evaluados en su condición neurológica al alta. Variable primaria de resultado: Muerte o examen neurológico alterado al alta. Variable secundaria de resultado: Encefalopatı́a; disfunción multiorgánica, hemorragia intra ventricular (IVH)
y PH arterial en 6horas. Resultados: Se randomizaron 27 recién nacidos para recibir bicarbonato de sodio (grupo bicarb
) y 28 para recibir dextrosa al 5%.Dieciocho de 27 (66.7%) recién nacidos en el grupo
bicarb y 18 de 28 (68%) en el grupo dextrosa sobrevivieron al alta (P = 0.84). 28% de los sobrevivientes en el grupo bicarb y 32% de los sobrevivientes
en el grupo dextrosa se encontraban neurológicamente anormales al alta (P = 0.10). El componente primario de resultado de muerte o examen neurológico alterado
fue similar en ambos grupos (52% versus 54%, P = 0.88). La incidencia de encefalopatı́a (74% versus 63%), edema cerebral
(52% versus 30%), necesidad de apoyo inotrópico (44% versus 29%), hemorragia intraventricular
(IVH), presión arterial media y ph a las 6 horas fueron similares en ambos grupos.
Conclusión: La administración de bicarbonato de sodio durante la reanimación neonatal no ayudó
a mejorar la sobreviva o resultado neurológico inmediato.
Keywords
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Article info
Publication history
Accepted:
October 23,
2003
Received in revised form:
September 28,
2003
Received:
August 1,
2003
Identification
Copyright
© 2003 Elsevier Ireland Ltd. Published by Elsevier Inc. All rights reserved.
