Survival and Survival without Major Morbidity Seem to Be Consistently Better throughout Gestational Age in 24- to 30-Week Gestational Age Very-Low-Birth-Weight Female Infants Compared to Males.

INTRODUCTION: Several studies showed advantages in outcomes for very-low-birth-weight (VLBW) female infants. It has been suggested that recent advances in perinatal care might have benefited boys relatively more than girls, making differences disappear. OBJECTIVES: The aims of the study were (1) to determine if sex differences in survival and survival without morbidity in VLBW infants are still present in the context of more advanced perinatal care and (2) to know whether these differences are consistent throughout gestational age (GA). METHODS: Retrospective cohort study in seven countries participating in the Spanish SEN1500 and the South American NEOCOSUR neonatal networks. We included VLBW infants 24-30 weeks' GA, born alive without major congenital anomalies (2013-2016). Major morbidity, survival, and survival without morbidity were compared between male and female infants overall and stratified by GA. RESULTS: 10,565 patients were included: 5,620 (53.2%) males and 4,945 (46.8%) females. Female infants exhibited a lower incidence rate ratio (95% CI) of respiratory distress syndrome: 0.91 (0.88, 0.94), necrotizing enterocolitis: 0.83 (0.74, 0.93), major brain damage: 0.79 (0.72, 0.86), moderate-severe bronchopulmonary dysplasia (BPD): 0.77 (0.72, 0.83), higher survival: 1.03 (1.01, 1.05), survival without BPD: 1.11 (1.07, 1.16), survival without major brain damage: 1.05 (1.02, 1.08), and survival without major morbidity: 1.14 (1.07, 1.21). Survival and survival without morbidity were almost consistently favourable to females throughout GA. CONCLUSIONS: Our findings suggest that perinatal results continue to be favourable for VLBW female infants in the context of current perinatology, and that they are almost consistent throughout GA.

Update in the Treatment of Retinopathy of Prematurity.

Retinopathy of prematurity (ROP) is an alteration in the development of the immature retina vascularization that frequently occurs in premature infants and is one of the leading causes of childhood blindness worldwide. In threshold stage retinopathy, laser photocoagulation is the standard treatment, particularly in those located in zone II. However, this therapy destroys parts of the retina and can lead to significant eye complications later in life. For this reason, in the last few years, antivascular endothelial growth factor agents are being used as monotherapy or as coadjuvant with laser, especially in retinopathy located in zone I. More recently, the administration of oral propranolol has been used as prevention and/or treatment of prethreshold retinopathy with encouraging results. This review provides an overview of the current evidence on newer treatment strategies for ROP. KEY POINTS: · Laser is the standard treatment in threshold retinopathy of prematurity (ROP).. · Prethreshold stages of the ROP have no treatment.. · Propranolol may prevent the progression of ROP..

Early use of combined exogenous surfactant and inhaled nitric oxide reduces treatment failure in persistent pulmonary hypertension of the newborn: a randomized controlled trial.

OBJECTIVE: To evaluate whether combined surfactant with inhaled nitric oxide (iNO) use will prevent newborns with hypoxemic respiratory failure (HRF) from developing an Oxygenation Index (OI) > 40. METHODS: 100 term newborns with acute HRF (OI ≥ 20) were randomized to: Surfactant+iNO: received iNO plus up to two doses of surfactant or iNO-Controls: received iNO+placebo. Main outcome was the development of severe HRF (OI > 40) despite iNO use. RESULTS: Baseline mean ± SD OI was 37.4 ± 14 for the Surfactant+iNO group and 38.2 ± 16 for the controls. Infants receiving surfactant+iNO improved their oxygenation faster, resulting in lower OI at 24 h: 12.9 ± 9 vs 18.7 ± 11 of controls, p < 0.05; and a lower proportion developing OI > 40: 24%(12/50) vs 50%(25/50) of controls, p < 0.02. Fewer infants receiving surfactant+iNO presented the combined outcome of death or ECMO: 16%(8/50) compared to 36%(18/50) of controls, p < 0.05. CONCLUSIONS: Early use of combined surfactant+iNO improves oxygenation preventing the progression to severe HRF. This may reduce mortality and ECMO need. TRIAL REGISTRATION NUMBER: ISRCTN13727958.

Trends in Perinatal Practices and Neonatal Outcomes of Very Low Birth Weight Infants during a 16-year Period at NEOCOSUR Centers.

OBJECTIVE: To describe trends in mortality, major morbidity, and perinatal care practices of very low birth weight infants born at NEOCOSUR Neonatal Network centers from January 1, 2001, through December 31, 2016. STUDY DESIGN: A retrospective analysis of prospectively collected data from all inborn infants with a birthweight of 500-1500 g and 23-35 weeks of gestation. RESULTS: We examined data for 13 987 very low birth weight infants with a mean birth weight of 1081 ± 281 g and a gestational age of 28.8 ± 2.9 weeks. Overall mortality was 26.8% without significant changes throughout the study period. Decreases in early onset sepsis from 6.3% to 2.8% (P <.001), late onset sepsis from 21.1% to 19.5% (P = .002), retinopathy of prematurity from 21.3% to 13.8% (P <.001), and hydrocephalus from 3.8% to 2.4% (P <.001), were observed. The incidence for bronchopulmonary dysplasia decreased from 17.3% to 16% (P = .043), incidence of severe intraventricular hemorrhage was 10.4%, necrotizing enterocolitis 11.1%, and periventricular leukomalacia 3.8%, and did not change over the study period. Administration of antenatal corticosteroids increased from 70.2% to 82.3% and cesarean delivery from 65.9% to 75.4% (P <.001). The use of conventional mechanical ventilation decreased from 67.7% to 63.9% (P <.001) and continuous positive airway pressure use increased from 41.3% to 64.3% (P <.001). Survival without major morbidity increased from 37.4% to 44.5% over the study period (P <.001). CONCLUSIONS: Progress in perinatal and neonatal care at network centers was associated with an improvement in survival without major morbidity of very low birth weight infants during a 16-year period. However, overall mortality remained unchanged.

Arterial oxygen saturation and heart rate in term newborn in the first hour after birth. / Saturación arterial de oxígeno y frecuencia cardíaca en recién nacidos de término sanos durante la primera hora post nacimiento.

INTRODUCTION: The pulse oximeter has been useful in the cardiorespiratory evaluation of the newborn. OBJECTIVE: To assess arterial oxygen saturation (SpO2) and heart rate (HR) in newborns in the first 60 minutes after birth. PATIENTS AND METHOD: Prospective observational study in healthy term newborns, delivered vaginally or by cesarean section, with maternal bonding, carried out at sea level. A continuous post- ductal SpO2 and HR record were obtained from minute 1 to 10 after birth, and then at 15, 30 and 60 minutes. The SpO2 and HR were measured with a Nellcor pulse oximeter. The software Stata v.14 was used for the statistical analysis. RESULTS: 324 healthy term newborns that met the inclusion criteria were included, of which 160 born vaginally and 164 by cesarean section. The SpO2 increased progres sively from minute 1 (58.7%) to minute 10 (94.5%). Newborns delivered vaginally had a significantly higher SpO2 until minute 10 after birth than those born by cesarean section (p < 0.001). In newborns delivered vaginally, HR was significantly higher in the first two minutes after birth, and then from minute 10 to 60 (p < 0.003). There were no differences by gender in SpO2 and HR. CONCLUSION: In term newborns, the SpO2 increases progressively, being higher in the first 10 minutes in those born vaginally. In newborns delivered vaginally, a higher HR was also observed in the first and last minutes evaluated.

Saturación arterial de oxígeno y frecuencia cardíaca en recién nacidos de término sanos durante la primera hora post nacimiento / Arterial oxygen saturation and heart rate in term newborn in the first hour after birth

INTRODUCCIÓN: El oxímetro de pulso ha sido útil en la evaluación cardiorrespiratoria del neonato. OBJETIVO: Evaluar la saturación arterial de oxígeno (SpO2) y frecuencia cardíaca (FC) en recién nacidos (RN) en los pri meros 60 minutos después del nacimiento. PACIENTES Y MÉTODO: Estudio observacional prospectivo en RN de término sanos, nacidos por vía vaginal o cesárea, con apego materno, efectuado a nivel del mar. Se obtuvo registro continuo de SpO2 post-ductal y de FC desde el minuto 1 al 10 post-natal, y luego a los 15, 30 y 60 minutos. La SpO2 y FC se midieron con un oxímetro de pulso Nellcor. Para el análisis estadístico se utilizó programa Stata v.14. RESULTADOS: Se enrolaron 324 RNT sanos, que cum plieron criterios de inclusión, de los cuales 160 nacieron por vía vaginal y 164 por cesárea. La SpO2 aumentó progresivamente desde el minuto 1 (58,7%) hasta el minuto 10 (94,5%). Los RN por vía vaginal presentaron una SpO2 significativamente mayor hasta el minuto 10 post-natal respecto a los nacidos por cesárea (p < 0,001). En los neonatos nacidos por vía vaginal, la FC fue significativamente mayor en los 2 primeros minutos post-natales, y luego desde el minuto 10 al 60 (p < 0,003). No se encontraron diferencias por género en SpO2 y FC. CONCLUSIÓN: En RNT la SpO2 post-natal aumenta progresivamente, siendo mayor en los primeros 10 minutos en los nacidos por vía vaginal. En los RN por vía vaginal se observó también una FC mayor en los primeros y últimos minutos evaluados.

INTRODUCTION: The pulse oximeter has been useful in the cardiorespiratory evaluation of the newborn. OBJECTIVE: To assess arterial oxygen saturation (SpO2) and heart rate (HR) in newborns in the first 60 minutes after birth. PATIENTS AND METHOD: Prospective observational study in healthy term newborns, delivered vaginally or by cesarean section, with maternal bonding, carried out at sea level. A continuous post ductal SpO2 and HR record were obtained from minute 1 to 10 after birth, and then at 15, 30 and 60 minutes. The SpO2 and HR were measured with a Nellcor pulse oximeter. The software Stata v.14 was used for the statistical analysis. RESULTS: 324 healthy term newborns that met the inclusion criteria were included, of which 160 born vaginally and 164 by cesarean section. The SpO2 increased progres sively from minute 1 (58.7%) to minute 10 (94.5%). Newborns delivered vaginally had a significantly higher SpO2 until minute 10 after birth than those born by cesarean section (p < 0.001). In newborns delivered vaginally, HR was significantly higher in the first two minutes after birth, and then from minute 10 to 60 (p < 0.003). There were no differences by gender in SpO2 and HR. CONCLUSION: In term newborns, the SpO2 increases progressively, being higher in the first 10 minutes in those born vaginally. In newborns delivered vaginally, a higher HR was also observed in the first and last minutes evaluated.

Bronchopulmonary dysplasia: risk prediction models for very-low- birth-weight infants.

OBJECTIVE: Our objective is to develop risk prediction models for moderate/severe bronchopulmonary dysplasia (BPD) and BPD and/or death in very-low-birth-weight infants (VLBWI) at birth, 3, 7, and 14 postnatal days. STUDY DESIGN: It is a multicenter study including 16,407 infants weighing 500-1500 g (2001-2015) from the Neocosur Network. BPD was defined as oxygen dependency at 36 weeks. Variables were selected using forward logistic regression models. Predictive values were evaluated using the ROC curve. RESULTS: In total, 2580 (15.7%) presented BPD and 6121 (37.3%) BPD/death. The AUC values for the BPD models were 0.788, 0.818, 0.827, and 0.894 respectively. For BPD/death, the AUC values were 0.860, 0.869, 0.867, and 0.906. BW and gestational age had higher contribution at birth; at later ages, the length of oxygen therapy and ventilation had the highest contribution. All AUC values were statistically significant when compared with a neutral value of 0.5 (p-value < 0.001). CONCLUSIONS: We developed high predictive power models for moderate/severe BPD and BPD/death at four postnatal ages.

[Prolonged initial empirical antibiotic treatment and the risk of morbidity and mortality in very low birthweight infants]. / Tratamiento antibiótico empírico inicial prolongado y riesgo de morbimortalidad en recién nacidos de muy bajo peso al nacer.

INTRODUCTION: The objective of this study is to evaluate the association between the duration of ini tial empirical antibiotic treatment and the subsequent development of late-onset sepsis, necrotizing enterocolitis (NEC) and death in very low birth weight (VLBW) infants. PATIENTS AND METHODS: Quantitative, cross-sectional, analytical study of VLBW infants admitted to the neonatal ICU were included over a period of five years. Initial empirical antibiotic therapy was that which started immediately after birth, without knowing the results of blood cultures. It was considered prolonged antibiotic therapy when the treatment duration was > 5 days. Perinatal variables, as well as the inci dence of late-onset sepsis, confirmed NEC and mortality were analyzed. RESULTS: 266 VLBW infants were studied, with an average gestational age and birth weight of 28.8 ± 2.5 weeks and 1.127 ± 264 g respectively. 213 infants received initial empiric antibiotic therapy (80.0%), which was prolonged in 67.6% of cases. All infants received two different antibiotics. 136 episodes of late-onset sepsis were described. The most common pathogens were coagulase-negative Staphylococcus and Staphylococcus aureus. Among the newborns with prolonged antibiotic therapy, there were 20 cases of confirmed NEC and 15 of the studied infants died (10.4%). When comparing the use of antibiotic therapy during > 5 days versus treatment less than 5 days duration, a statistically significant association was observed between prolonged antibiotic therapy and late-onset sepsis (p = 0.03) and confirmed NEC (p = 0.03), but not of mortality (p = 0.12). CONCLUSION: The use of empirical antibiotic therapy for five days or more was associated with an increased risk of late-onset sepsis and NEC, but not of mortality in VLBW infants.

Tratamiento antibiótico empírico inicial prolongado y riesgo de morbimortalidad en recién nacidos de muy bajo peso al nacer / Prolonged initial empirical antibiotic treatment and the risk of morbidity and mortality in very low birthweight infants

Resumen: Introducción: El objetivo de este estudio es evaluar la asociación entre la duración del tratamien to antibiótico empírico inicial y el desarrollo posterior de sepsis tardía, enterocolitis necrotizante (NEC) y muerte en recién nacidos de muy bajo peso al nacer (RNMBP). Pacientes y Método: Estudio cuantitativo, transversal analítico, en RNMBP ingresados a UCI neonatal durante un período de 5 años. Se consideró antibioterapia empírica inicial aquella que comenzó desde el nacimiento, sin conocer resultado de hemocultivos. Antibioterapia prolongada se estimó cuando la duración del tratamiento fue > 5 días. Se analizaron variables perinatales, e incidencia de sepsis tardía, NEC confirmada y mortalidad. Resultados: Se estudiaron un total de 266 RNMBP, con edad gestacional y peso de nacimiento promedios de 28,8 ± 2,5 semanas y 1.127 ± 264 g respec tivamente. Recibieron antibioterapia empírica inicial 213 (80,0%), siendo ésta prolongada en el 67,6%. Todos recibieron antibioterapia biasociada. Se pesquisaron 136 episodios de sepsis tardía, siendo los gérmenes más frecuentes el Staphylococcus coagulasa negativo y el Staphylococcus au reus. Del total de RN con antibioterapia empírica prolongada, hubo 20 casos de NEC confirmada y 15 fallecidos (10,4%) en el grupo analizado. Al comparar el uso de antibioterapia > 5 días ver sus tratamiento menor de 5 días, se observó una asociación estadísticamente significativa entre la antibioterapia prolongada y sepsis tardía (p = 0,03) y además de NEC confirmada (p = 0,03), pero no de mortalidad (p = 0,12). Conclusión: El uso de antibioterapia empírica inicial por 5 días o más se asoció a un riesgo aumentado de sepsis tardía y de NEC, pero no de la mortalidad en RNMBPN.

Abstract: Introduction: The objective of this study is to evaluate the association between the duration of ini tial empirical antibiotic treatment and the subsequent development of late-onset sepsis, necrotizing enterocolitis (NEC) and death in very low birth weight (VLBW) infants. Patients and Methods: Quantitative, cross-sectional, analytical study of VLBW infants admitted to the neonatal ICU were included over a period of five years. Initial empirical antibiotic therapy was that which started im mediately after birth, without knowing the results of blood cultures. It was considered prolonged antibiotic therapy when the treatment duration was > 5 days. Perinatal variables, as well as the inci dence of late-onset sepsis, confirmed NEC and mortality were analyzed. Results: 266 VLBW infants were studied, with an average gestational age and birth weight of 28.8 ± 2.5 weeks and 1.127 ± 264 g respectively. 213 infants received initial empiric antibiotic therapy (80.0%), which was prolonged in 67.6% of cases. All infants received two different antibiotics. 136 episodes of late-onset sepsis were described. The most common pathogens were coagulase-negative Staphylococcus and Staphylococcus aureus. Among the newborns with prolonged antibiotic therapy, there were 20 cases of confirmed NEC and 15 of the studied infants died (10.4%). When comparing the use of antibiotic therapy during > 5 days versus treatment less than 5 days duration, a statistically significant association was observed between prolonged antibiotic therapy and late-onset sepsis (p = 0.03) and confirmed NEC (p = 0.03), but not of mortality (p = 0.12). Conclusion: The use of empirical antibiotic therapy for five days or more was associated with an increased risk of late-onset sepsis and NEC, but not of mortality in VLBW infants.

Late Onset Sepsis in Very Low Birth Weight Infants in the South American NEOCOSUR Network.

BACKGROUND: The main aim is to determine the incidence and associated factors of late onset sepsis (LOS) in very low birth weight infants (500-1500 g), from the NEOCOSUR Network during years 2001-2013. Secondary objectives are to describe the microbiology of the first and second episode of LOS and to study the association between catheter dwell time and LOS. METHODS: Demographic information and outcome data are prospectively and routinely collected across the network using predefined diagnostic criteria and online data entry. LOS was confirmed by isolation of the organism in blood or through cerebrospinal fluid in cultures. The participating countries were Argentina, Brazil, Chile, Paraguay, Peru and Uruguay. RESULTS: Overall incidence was 22.2% (3066/13,821). Infants who developed LOS were smaller by weight and gestational age; also, they feature less prenatal care and prenatal steroids, and longer hospital stays. A greater number of infants in the LOS group had 1 minute Apgar Scores ≤3. Multivariate logistic regression analysis showed a positive association between LOS and necrotizing enterocolitis, mechanical ventilation requirements, patent ductus arteriosus, oxygen dependency at 36 weeks and death. The majority of first LOS episode was caused by coagulase-negative staphylococci (44.3%). An increased risk of LOS was observed in relation to catheter dwell time (6% per day of stay of central lines). CONCLUSIONS: The incidence of LOS was associated with mechanical ventilation, patent ductus arteriosus, necrotizing enterocolitis and death. LOS was an important cause of morbidity and mortality in very low birth weight infants in our network, and coagulase-negative staphylococci was the most frequent causative microorganism.

Diagnóstico de los trastornos respiratorios del sueño en recién nacidos con sospecha de apneas: comparación entre la saturometría nocturna y la poligrafía / Diagnosis of respiratory sleep disorders in newborns with suspected apneas: comparison between nocturnal saturometry and polygraphy

Resumen Introducción: La Saturometría Nocturna Continua (SpChC), es utilizada en Unidades de Neonato logia para detección de eventos de hipoxemia en Recién Nacidos (RN) con episodios de apneas. La Poligrafía (PG) presenta un número mayor de canales de medición. El objetivo fue evaluar el rendi miento diagnóstico de la SpOhC respecto a la Poligrafía en RN con sospecha de apneas. Pacientes y Método: Se analizaron retrospectivamente resultados de SpOhC y PG realizadas en forma simultáneas en RN con sospecha de apneas, en un periodo de tres años. Se utilizó un saturómetro Masimo Radi-cal-7® con 2 canales y un polígrafo Apnea Link Plus® con 5 canales de registro simultáneos. Se con sideró PG alterada: índice de desaturaciones bajo 80% por hora > a 1 y/o número de desaturaciones bajo 80% > 20 segundos mayor a uno en todo el registro validado y/o índice de apnea hipoapnea > a 1 evento por hora. Paralelamente, se definió SpOhC alterada cuando uno o ambos de los criterios de saturometria bajo 80%, estaban alterados. Se calcularon valores de sensibilidad, especificidad, valores predictivos y Likelihood Ratio (LLR) para la SpÜ2C. Los resultados se expresaron en valor absoluto, con 95% de intervalo de confianza. Resultados: Se realizaron 40 SpÜ2C y PG simultáneos; un 80% (32/40) de ellos fueron RN prematuros, 60% (24/40) varones. Un 38% (15/40) de las SpOhC y un 15% (6/40) de las PG resultaron alteradas (p < 0,05). La SpÜ2C presenta una Sensibilidad 100%, Especificidad 74%, El VPP 40%, VPN 100%, LLR + 3,78 y LLR-0. Conclusión: En los RN estudiados, la SpC2C posee un alto valor diagnóstico, sin embargo, puede presentar falsos positivos; por lo cual se sugiere utilizar como método de tamizaje y realizar confirmación diagnóstica con otro examen de sueño, como la PG.

Abstract Introduction: Night Continuous Saturometry (CSO2) is used in Neonatal Units to detect events of hypoxemia in Newborns (NB) with apnea episodes. Polygraphy (PG) has a larger number of measuring channels. Our goal was to evaluate the diagnostic performance of CSO2 compared to Polygra phy in NB with suspected sleep apneas. Patients and Method: Results of CSO2 and PG performed simultaneously in RN with suspected apneas were retrospectively analyzed over a three-year period. A 2-channel Masimo Radical-7® pulse oximeter and an Apnea Link Plus® polygraph with 5 simulta neous recording channels were used. Altered PG was defined as: desaturation index under 80% per hour > 1 and/or number of desaturations under 80% > 20 seconds greater than one in the whole va lidated registry and/or hypoapnea apnea index > 1 event per hour. In parallel, altered SpO2C was de fined when one or both of the 80% saturation criteria were altered. Sensitivity, specificity, predictive values and Likelihood Ratio (LLR) for CSO2 were calculated. Results were expressed in absolute value, with 95% confidence interval. Results: Simultaneous 40 CSO2 and PG were performed; 80% (32/40) of them were preterm infants, 60% (24/40) males. 38% (15/40) of the CSO2 and 15% (6/40) of the PGs were altered (p < 0.05). CSO2 has a 100% Sensitivity, 74% Specificity, 40% VPP, 100% VPN, LLR + 3.78 and LLR-0. Conclusion: In the studied NB, CSO2 has a high diagnostic value, however, it may present false positives; It is suggested to use as a screening method and to perform diagnostic confirmation with another sleep test, such as PG.

[Diagnosis of respiratory sleep disorders in newborns with suspected apneas: comparison between nocturnal saturometry and polygraphy]. / Diagnóstico de los trastornos respiratorios del sueño en recién nacidos con sospecha de apneas: comparación entre la saturometría nocturna y la poligrafía.

INTRODUCTION: Night Continuous Saturometry (CSO2) is used in Neonatal Units to detect events of hypoxemia in Newborns (NB) with apnea episodes. Polygraphy (PG) has a larger number of measuring channels. Our goal was to evaluate the diagnostic performance of CSO2 compared to Polygra phy in NB with suspected sleep apneas. PATIENTS AND METHOD: Results of CSO2 and PG performed simultaneously in RN with suspected apneas were retrospectively analyzed over a three-year period. A 2-channel Masimo Radical-7® pulse oximeter and an Apnea Link Plus® polygraph with 5 simulta neous recording channels were used. Altered PG was defined as: desaturation index under 80% per hour > 1 and/or number of desaturations under 80% > 20 seconds greater than one in the whole va lidated registry and/or hypoapnea apnea index > 1 event per hour. In parallel, altered SpO2C was de fined when one or both of the 80% saturation criteria were altered. Sensitivity, specificity, predictive values and Likelihood Ratio (LLR) for CSO2 were calculated. Results were expressed in absolute value, with 95% confidence interval. RESULTS: Simultaneous 40 CSO2 and PG were performed; 80% (32/40) of them were preterm infants, 60% (24/40) males. 38% (15/40) of the CSO2 and 15% (6/40) of the PGs were altered (p < 0.05). CSO2 has a 100% Sensitivity, 74% Specificity, 40% VPP, 100% VPN, LLR + 3.78 and LLR-0. CONCLUSION: In the studied NB, CSO2 has a high diagnostic value, however, it may present false positives; It is suggested to use as a screening method and to perform diagnostic confirmation with another sleep test, such as PG.

Arterial oxygen saturation and heart rate after birth in newborns with and without maternal bonding.

BACKGROUND: The aim of this study was to determine and compare changes in arterial oxygen saturation (SpO2 ) and heart rate (HR) in healthy term infants with and without maternal bonding. METHOD: This was a prospective observational study in healthy term infants. SpO2 and HR were recorded from 1 to 10 min after birth. After this, SpO2 and HR were registered at 15, 30 and 60 min and then at 12 and 24 h after birth. SpO2 and HR were measured with a pulse oximeter. RESULTS: A total of 216 healthy term infants were divided into three different groups: 136 (63%) born by vaginal delivery, 56 (26%) born by cesarean section with bonding, and 24 (11%) born by cesarean section without bonding. No difference in SpO2 was found in babies born by cesarean section with or without maternal bonding. In neonates delivered vaginally, SpO2 was significantly higher during the first 10 min after birth than in neonates born by cesarean section with bonding (P < 0.05). Compared with infants born by cesarean section without bonding, this tendency was not significant. In general, HR was similar across groups, although, for infants born by cesarean section, neonates who received bonding had lower HR from 6 to 8 min (P < 0.05). CONCLUSIONS: In healthy term newborns, maternal bonding in infants born by cesarean section did not have effects on SpO2 . Some differences were observed in HR between infants born by cesarean section with and without bonding.

Oral propranolol in early stages of retinopathy of prematurity.

OBJECTIVE: To assess the effect of oral propranolol on the progression of early stages of retinopathy of prematurity (ROP) in very low birth weight (VLBW) infants. METHODS: We analyzed VLBW infants with ROP (stages 2-3, zones II-III). Newborns received oral propranolol (0.5 mg/kg/dose q8h), and were monitored throughout the treatment period for possible side effects. Propranolol was administered until regression of ROP. A historic control group of patients with equivalent ROP was used. We compared characteristics of both groups and the progression of retinopathy. RESULTS: Forty-seven newborns were included, 20 in the propranolol group and 27 in the control group. There were no significant differences in gestational age, birthweight or gender. The mean duration of treatment with propranolol was 58.2±17.6 days. Most patients started treatment with stage 2 disease (65.0%), and had zone III involvement (55.0%). In the treated group, 90.0% (18/20) of patients did not require intervention with laser or bevacizumab, compared to 51.8% in the control group (P<0.005). No cases of bradycardia, hypotension or hypoglycemia were observed. CONCLUSIONS: Oral propranolol in early stages of ROP could prevent disease progression and reduce the need for invasive rescue therapy with laser or bevacizumab. No significant side effects were reported.

Randomized trial of early bubble continuous positive airway pressure for very low birth weight infants.

OBJECTIVE: To determine whether very low birth weight infants (VLBWIs), initially supported with continuous positive airway pressure (CPAP) and then selectively treated with the INSURE (intubation, surfactant, and extubation to CPAP; CPAP/INSURE) protocol, need less mechanical ventilation than those supported with supplemental oxygen, surfactant, and mechanical ventilation if required (Oxygen/mechanical ventilation [MV]). STUDY DESIGN: In a multicenter randomized controlled trial, spontaneously breathing VLBWIs weighing 800-1500 g were allocated to receive either therapy. In the CPAP/INSURE group, if respiratory distress syndrome (RDS) did not occur, CPAP was discontinued after 3-6 hours. If RDS developed and the fraction of inspired oxygen (FiO(2)) was >0.35, the INSURE protocol was indicated. Failure criteria included FiO(2) >0.60, severe apnea or respiratory acidosis, and receipt of more than 2 doses of surfactant. In the Oxygen/MV group, in the presence of RDS, supplemental oxygen without CPAP was given, and if FiO(2) was >0.35, surfactant and mechanical ventilation were provided. RESULTS: A total of 256 patients were randomized to either the CPAP/INSURE group (n = 131) or the Oxygen/MV group (n = 125). The need for mechanical ventilation was lower in the CPAP/INSURE group (29.8% vs 50.4%; P = .001), as was the use of surfactant (27.5% vs 46.4%; P = .002). There were no differences in death, pneumothorax, bronchopulmonary dysplasia, and other complications of prematurity between the 2 groups. CONCLUSION: CPAP and early selective INSURE reduced the need for mechanical ventilation and surfactant in VLBWIs without increasing morbidity and death. These results may be particularly relevant for resource-limited regions.

[Impact of respiratory distress syndrome in very low birth weight infants: a multicenter South-American study]. / Impacto del síndrome de dificultad respiratoria en recién nacidos de muy bajo peso de nacimiento: estudio multicéntrico sudamericano.

OBJECTIVE: To analyze the incidence, risk factors, major morbidity, mortality and resource employment in very low birth weight infants (< 1500 g) with respiratory distress syndrome (RDS). METHODS: Descriptive study using prospectively obtained on-line information from a data base of 20 units belonging to the South American Neocosur Network. A total of 5991 VLBW infants were registered during years 2002-2007. RESULTS: The mean gestacional age was 29.1 weeks (95% CI 29.06-29.21) and the mean of birth weight was 1100.5 g (95% CI 1093.79-1107.37). The global incidence of RDS was 74% (95% CI 73-75). Antenatal steroids were administered to 73% of this population. The main risk factor was lower gestational age (p< 0.001); where as prenatal steroids (OR: 0.59; 95% CI 0.49-0.72), female gender (OR: 0.77; 95% CI 0.67-0.89) and premature rupture of membranes (OR: 0.81; 95% CI 0.68-0.96) were protective factors. Antenatal steroids was also associated with a decrease in mortality in those infants that presented with RDS (OR: 0.40; 95% CI 0.34-0.47). Use of resources was higher in the group with RDS, with a greater use of surfactant (74.3% vs. 7.3%, p< 0.001), mechanical ventilation (82.1% vs. 23.8%, p< 0.001), and more days of oxygen (median of 8 vs. 1 day, p< 0.001) and hospitalization (median of 61 vs. 45 days, p< 0.001). RDS was associated to an increase risk in the incidence of ROP, PDA, late onset sepsis, severe IVH and oxygen requirement at 36 weeks of corrected gestational age. CONCLUSIONS: RDS had a high incidence in very low birth weight infants, despite the frequent use of antenatal steroids. VLBW Infants with RDS had a higher mortality and an increase risk of relevant morbidity. RDS also increased use of resources.

Impacto del síndrome de dificultad respiratoria en recién nacidos de muy bajo peso de nacimiento: estudio multicéntrico sudamericano / Impact of respiratory distress syndrome in very low birth weight infants: a multicenter South-American study

Objetivo. Analizar la incidencia, factores de riesgo, morbilidad relevante, empleo de recursos y mortalidad, en recién nacidos (RN) de muy bajo peso de nacimiento (<1500 g) con síndrome dedificultad respiratoria (SDR).Población y métodos. Estudio observacional y analítico. Se incluyeron 5991 RN vivos <1500 g de las 20 unidades de la Red Sudamericana de Neonatología (Neocosur) entre 2002 y 2007. Los datos se ingresaron prospectivamente en fichaselectrónicas en línea en el sitio web.Resultados. La edad gestacional (media) fue de 29,1 semanas (IC 95 por ciento 29,06-29,2) y el peso de nacimiento (medio) de 1100,5 g (IC 95 por ciento 1093,79-1107,3). La incidencia de SDR fue del 74 por ciento (IC 95 por ciento73-75). El principal factor de riesgo para el SDR fue la menor edad gestacional (p< 0,001), mientrasque la administración antenatal de corticoides (OR: 0,59; IC 95 por ciento 0,49-0,72), sexo femenino (OR: 0,77; IC 95 por ciento 0,67-0,89) y rotura prematura de membranas (OR: 0,81; IC 95 por ciento 0,68-0,96)constituyeron factores protectores. En los RN con SDR, el empleo antenatal de corticoides se asoció a menor mortalidad (OR: 0,40; IC 95 por ciento0,34-0,47). El uso de recursos fue mayor en el grupo con SDR, con más empleo de surfactante(74,3 por ciento contra 7,3 por ciento, p< 0,001), de ventilaciónmecánica (82,1 por ciento contra 23,8 por ciento, p< 0,001), más días de oxigenoterapia (p< 0,001) y de hospitalización (p< 0,001).Conclusiones. El SDR tuvo una elevada incidencia en RN< 1500 g y produjo un aumento en la mortalidad, morbilidad y en el empleo de recursos.

Objective. To analyze the incidence, risk factors, major morbidity, mortality and resource employment in very low birth weight infants (< 1500 g) with respiratory distress syndrome (RDS).Methods. Descriptive study using prospectively obtained on-line information from a data base of 20 units belonging to the South American Neocosur Network. A total of 5991 VLBW infants were registered during years 2002-2007. Results. The mean gestacional age was 29.1 weeks (95 percent CI 29.06-29.21) and the mean of birth weight was 1100.5 g (95 percent CI 1093.79-1107.37). The global incidence of RDS was 74 percent (95 percent CI 73-75). Antenatal steroids were administered to 73 percent of this population. The main risk factor was lower gestational age (p< 0.001); where as prenatal steroids (OR: 0.59; 95 percent CI 0.49-0.72), female gender (OR: 0.77; 95 percent CI 0.67-0.89) and premature rupture of membranes (OR: 0.81; 95 percent CI 0.68-0.96) were protective factors. Antenatal steroids was also associated with a decrease in mortality in those infants that presented with RDS (OR: 0.40; 95 percent CI 0.34-0.47). Use of resources was higher in the group with RDS, with a greater use of surfactant (74.3 percent vs. 7.3 percent, p< 0.001), mechanical ventilation (82.1 percent vs. 23.8 percent, p< 0.001), and more days of oxygen (median of 8 vs. 1 day, p< 0.001) and hospitalization (median of 61 vs. 45 days, p< 0.001). RDS was associated to an increase risk in the incidence of ROP, PDA, late onset sepsis, severe IVH and oxygen requirement at 36 weeks of corrected gestational age. Conclusions. RDS had a high incidence in very low birth weight infants, despite the frequent use of antenatal steroids. VLBW Infants withRDS had a higher mortality and an increase risk of relevant morbidity. RDS also increased use of resources.

A new score for predicting neonatal very low birth weight mortality risk in the NEOCOSUR South American Network.

OBJECTIVE: To develop and validate a model for very low birth weight (VLBW) neonatal mortality prediction, based on commonly available data at birth, in 16 neonatal intensive care units (NICUs) from five South American countries. STUDY DESIGN: Prospectively collected biodemographic data from the Neonatal del Cono Sur (NEOCOSUR) Network between October 2000 and May 2003 in infants with birth weight 500 to 1500 g were employed. A testing sample and crossvalidation techniques were used to validate a statistical model for risk of in-hospital mortality. The new risk score was compared with two existing scores by using area under the receiver operating characteristic curve (AUC). RESULTS: The new NEOCOSUR score was highly predictive for in-hospital mortality (AUC=0.85) and performed better than the Clinical Risk Index for Babies (CRIB) and the NICHD risk models when used in the NEOCOSUR Network. The new score is also well calibrated - it had good predictive capability for in-hospital mortality at all levels of risk (HL test=11.9, p=0.85). The new score also performed well when used to predict in hospital neurological and respiratory complications. CONCLUSIONS: A new and relatively simple VLBW mortality risk score had a good prediction performance in a South American network population. This is an important tool for comparison purposes among NICUs. This score may prove to be a better model for application in developing countries.

A multicenter, randomized, masked, comparison trial of lucinactant, colfosceril palmitate, and beractant for the prevention of respiratory distress syndrome among very preterm infants.

BACKGROUND AND OBJECTIVE: Evidence suggests that synthetic surfactants consisting solely of phospholipids can be improved through the addition of peptides, such as sinapultide, that mimic the action of human surfactant protein-B (SP-B). A synthetic surfactant containing a mimic of SP-B may also reduce the potential risks associated with the use of animal-derived products. Our objective was to compare the efficacy and safety of a novel synthetic surfactant containing a functional SP-B mimic (lucinactant; Discovery Laboratories, Doylestown, PA) with those of a non-protein-containing synthetic surfactant (colfosceril palmitate; GlaxoSmithKline, Brentford, United Kingdom) and a bovine-derived surfactant (beractant; Abbott Laboratories, Abbott Park, IL) in the prevention of neonatal respiratory distress syndrome (RDS) and RDS-related death. METHODS: We assigned randomly (double-masked) 1294 very preterm infants, weighing 600 to 1250 g and of < or =32 weeks gestational age, to receive colfosceril palmitate (n = 509), lucinactant (n = 527), or beractant (n = 258) within 20 to 30 minutes after birth. Primary outcome measures were the rates of RDS at 24 hours and the rates of death related to RDS during the first 14 days after birth. All-cause mortality rates, bronchopulmonary dysplasia (BPD) rates, and rates of other complications of prematurity were prespecified secondary outcomes. Primary outcomes, air leaks, and causes of death were assigned by an independent, masked, adjudication committee with prespecified definitions. The study was monitored by an independent data safety monitoring board. RESULTS: Lucinactant reduced significantly the incidence of RDS at 24 hours, compared with colfosceril (39.1% vs 47.2%; odds ratio [OR]: 0.68; 95% confidence interval [CI]: 0.52-0.89). There was no significant difference in comparison with beractant (33.3%). However, lucinactant reduced significantly RDS-related mortality rates by 14 days of life, compared with both colfosceril (4.7% vs 9.4%; OR: 0.43; 95% CI: 0.25-0.73) and beractant (10.5%; OR: 0.35; 95% CI: 0.18-0.66). In addition, BPD at 36 weeks postmenstrual age was significantly less common with lucinactant than with colfosceril (40.2% vs 45.0%; OR: 0.75; 95% CI: 0.56-0.99), and the all-cause mortality rate at 36 weeks postmenstrual age was lower with lucinactant than with beractant (21% vs 26%; OR: 0.67; 95% CI: 0.45-1.00). CONCLUSIONS: Lucinactant is a more effective surfactant preparation than colfosceril palmitate for the prevention of RDS. In addition, lucinactant reduces the incidence of BPD, compared with colfosceril palmitate, and decreases RDS-related mortality rates, compared with beractant. Therefore, we conclude that lucinactant, the first of a new class of surfactants containing a functional protein analog of SP-B, is an effective therapeutic option for preterm infants at risk for RDS.