RESUMO
Hypoglycemia is the most frequent metabolic disorder in newborns; the administration of 40% glu cose gel in the oral mucosa could be as effective in its correction as the administration of formula milk, not interfering with breastfeeding. OBJECTIVE: To evaluate the efficacy of 40% glucose gel com pared with formula milk in the treatment of early asymptomatic hypoglycemia in newborns with risk factors. PATIENTS AND METHOD: Randomized clinical trial, non-inferiority, conducted in a private hos pital. Newborns attended in rooming-in with the following risk factors were included: late preterm, large and small for gestational age at term, and children of diabetic mothers. In the presence of hy poglycemia, one group received 40% glucose gel (A) in the oral mucosa and another group received formula milk (B). Therapeutic failure was considered as persistence or repetition of hypoglycemia in the first 48h of life. RESULTS: 866 NBs with risk factors were registered over 36 month; 278 (32.1 %) presented hypoglycemia; 105 NBs in group A and 115 in group B completed the study. 75 (71 %) NBs in group A and 104 (90,4 %) in group B achieved hypoglycemia correction. After analyzing the trends obtained, it was decided to discontinue the study. CONCLUSIONS: The administration of 40% glucose gel was not equivalent to the administration of formula milk in the treatment of early asymptomatic hypoglycemia in newborns with risk factors.
Assuntos
Doenças Fetais , Hipoglicemia , Doenças do Recém-Nascido , Feminino , Criança , Recém-Nascido , Humanos , Glucose/uso terapêutico , Fatores de Risco , Aleitamento Materno , Doenças do Recém-Nascido/tratamento farmacológicoRESUMO
El cuidado e higiene del cordón umbilical (CU) es motivo de preocupación para los padres. Objetivos. Principal: comparar la efectividad del secado natural del CU, con la práctica habitual (alcohol), en la reducción del tiempo de caída del CU y la incidencia de infecciones en el recién nacido (RN). Secundarios: comparar la colonización bacteriana intrahospitalaria del CU, y el grado de satisfacción de los padres en ambos grupos. Población. RN de término asistidos en el Servicio de Neonatología del Hospital Privado del Sur, cuyos padres consintieron participar. Material y métodos. Estudio clínico prospectivo, controlado, abierto, aleatorizado, en dos grupos: Grupo Estudio (secado natural y baño diario con jabón neutro) y Grupo Control (alcohol 70%). Variables principales: tiempo de caída del CU; presencia de infecciones en piel o conjuntivas en el primer mes de vida; colonización del cordón y satisfacción parental. Análisis por intención de tratamiento. Resultados. Se analizaron 362 RN, 181 en cada grupo. La higiene con baño se asoció con una mayor frecuencia de colonización intrahospitalaria del CU (OR 1,92 [1,22 - 3,12], p <0,01) y caída del cordón más temprana (mediana [rango intercuartílico]= 6,00 [3] vs. 7,00 [4] días en el grupo control; p <0,001). No se observó un mayor riesgo de infecciones. El grado de satisfacción parental fue similar y elevado en ambos grupos. Conclusiones. El secado natural y baño redujo el tiempo de caída del CU; aun cuando la frecuencia de colonización fue mayor en el grupo estudio, no se encontró un riesgo mayor de infecciones en el primer mes.
Background. Umbilical cord (UC) care is a cause of concern for parents from birth until its separation. Standard practice in Argentina includes frequent cleansing of the UC with alcohol and body bath only two days after its separation. The effect of different methods of UC care on its separation time and on colonization with microorganisms has been insufficiently explored. Objectives. Main: To compare the effect on time of UC separation when using body bath with neutral soap followed by natural drying of the UC vs. standard care. Secondary: a) colonization rates during hospitalization; b) incidence of skin infection and conjunctivitis and c) parental comfort with both types of care. Population. Normal term newborns (>37 weeks), born at the HPS, and whose parents provided informed consent. Methods. Open prospective controlled clinical trial, with random allocation to two groups: study group -natural drying of the UC and body bath with neutral soap-and control group -UC hygiene with alcohol 70% at each diaper change until its separation and bath two days later-. UC separation time; UC colonization during hospital stay and skin and conjunctive infections in the first 30 days of life were monitored. Analysis was by intention-to-treat. Results. 362 newborns were included, 181 in each group. The groups were well balanced in baseline characteristics. Being in the study group was associated with a shorter time to UC separation (median [interquartile range]= 6.00 [3] vs. 7.00 [4] days; p <0.001) and an increased frequency in nosocomial UC colonization (adjusted OR= 1.92 [1.22- 3.12], p= 0.007). No difference in the rate of infections was observed between both groups. Parental comfort was high and similar in both groups. Conclusions. Compared to standard practice in Argentina, body bath with neutral soap and natural drying of the UC reduced the time to cord separation. This practice increased the colonization rate, but the risk of skin and conjunctive infections was apparently not modified by it. However, the study has insufficient power for secondary outcomes. Health care providers should continue to develop evidence to support or eliminate historical practices.
RESUMO
BACKGROUND: Umbilical cord (UC) care is a cause of concern for parents right from birth until its separation. Standard practice in Argentina includes frequent cleansing of the UC with alcohol and body bath only two days after its separation. The effect of different methods of UC care on its separation time and on colonization with microorganisms has been insufficiently explored. OBJECTIVES: Main: To compare the effect on time of UC separation when using body bath with neutral soap followed by natural drying of the UC vs. standard care. Secondary: a) colonization rates during hospitalization; b) incidence of skin infection and conjunctivitis and c) parental comfort with both types of care. POPULATION: Normal term newborns (≥37 weeks), born at the HPS, and whose parents provided informed consent. METHODS: Open prospective controlled clinical trial, with random allocation to two groups: study group -natural drying of the UC and body bath with neutral soap- and control group -UC hygiene with alcohol 70% at each diaper change until its separation and bath two days later-. UC separation time; UC colonization during hospital stay and skin and conjunctive infections in the first 30 days of life were monitored. Analysis was by intention-to-treat. RESULTS: 362 newborns were included, 181 in each group. The groups were well balanced in baseline characteristics. Being in the study group was associated with a shorter time to UC separation (median [interquartile range]= 6.00 [3] vs. 7.00 [4] days; p <0.001) and an increased frequency in nosocomial UC colonization (adjusted OR= 1.92 [1.22- 3.12], p= 0.007). No difference in the rate of infections was observed between both groups. Parental comfort was high and similar in both groups. CONCLUSIONS: Compared to standard practice in Argentina, body bath with neutral soap and natural drying of the UC reduced the time to cord separation. This practice increased the colonization rate, but the risk of skin and conjunctive infections was apparently not modified by it. However, the study has insufficient power for secondary outcomes. Health care providers should continue to develop evidence to support or eliminate historical practices.
Assuntos
Banhos , Etanol/administração & dosagem , Cuidado do Lactente/métodos , Cordão Umbilical , Feminino , Humanos , Recém-Nascido , Masculino , Estudos ProspectivosRESUMO
El cuidado e higiene del cordón umbilical (CU) es motivo de preocupación para los padres. Objetivos. Principal: comparar la efectividad del secado natural del CU, con la práctica habitual (alcohol), en la reducción del tiempo de caída del CU y la incidencia de infecciones en el recién nacido (RN). Secundarios: comparar la colonización bacteriana intrahospitalaria del CU, y el grado de satisfacción de los padres en ambos grupos. Población. RN de término asistidos en el Servicio de Neonatología del Hospital Privado del Sur, cuyos padres consintieron participar. Material y métodos. Estudio clínico prospectivo, controlado, abierto, aleatorizado, en dos grupos: Grupo Estudio (secado natural y baño diario con jabón neutro) y Grupo Control (alcohol 70%). Variables principales: tiempo de caída del CU; presencia de infecciones en piel o conjuntivas en el primer mes de vida; colonización del cordón y satisfacción parental. Análisis por intención de tratamiento. Resultados. Se analizaron 362 RN, 181 en cada grupo. La higiene con baño se asoció con una mayor frecuencia de colonización intrahospitalaria del CU (OR 1,92 [1,22 - 3,12], p <0,01) y caída del cordón más temprana (mediana [rango intercuartílico]= 6,00 [3] vs. 7,00 [4] días en el grupo control; p <0,001). No se observó un mayor riesgo de infecciones. El grado de satisfacción parental fue similar y elevado en ambos grupos. Conclusiones. El secado natural y baño redujo el tiempo de caída del CU; aun cuando la frecuencia de colonización fue mayor en el grupo estudio, no se encontró un riesgo mayor de infecciones en el primer mes.
Background. Umbilical cord (UC) care is a cause of concern for parents right from birth until its separation. Standard practice in Argentina includes frequent cleansing of the UC with alcohol and body bath only two days after its separation. The effect of different methods of UC care on its separation time and on colonization with microorganisms has been insuffciently explored. Objectives. Main: To compare the effect on time of UC separation when using body bath with neutral soap followed by natural drying of the UC vs. standard care. Secondary: a) colonization rates duri ng hospitalization; b) incidence of skin infection and conjunctivitis and c) parental comfort with both types of care. Population. Normal term newborns (≥37 weeks), born at the HPS, and whose parents provided informed consent. Methods. Open prospective controlled clinical trial, with random allocation to two groups: study group -natural drying of the UC and body bath with neutral soap- and control group -UC hygiene with alcohol 70% at each diaper change until its separation and bath two days later-. UC separation time; UC colonization during hospital stay and skin and conjunctive infections in the frst 30 days of life were monitored. Analysis was by intention-to-treat. Results. 362 newborns were included, 181 in each group. The groups were well balanced in baseline characteristics. Being in the study group was associated with a shorter time to UC separation (median [interquartile range]= 6.00 [3] vs. 7.00 [4] days; p <0.001) and an increased frequency in nosocomial UC colonization (adjusted OR= 1.92 [1.22- 3.12], p= 0.007). No difference in the rate of infections was observed between both groups. Parental comfort was high and similar in both groups. Conclusions. Compared to standard practice in Argentina, body bath with neutral soap and natural drying of the UC reduced the time to cord separation. This practice increased the colonization rate, but the risk of skin and conjunctive infections was apparently not modifed by it. However, the study has insuffcient power for secondary outcomes. Health care providers should continue to develop evidence to support or eliminate historical practices.
