Hypothermia Plus Melatonin in Asphyctic Newborns: A Randomized-Controlled Pilot Study.

OBJECTIVES: To investigate the effect of adding melatonin to hypothermia treatment on neurodevelopmental outcomes in asphyctic newborns. DESIGN: Pilot multicenter, randomized, controlled, double-blind clinical trial. Statistical comparison of results obtained in two intervention arms: hypothermia plus placebo and hypothermia plus melatonin. SETTING: Level 3 neonatal ICU. PATIENTS: Twenty-five newborns were recruited. INTERVENTIONS: The hypothermia plus melatonin patients received a daily dose of IV melatonin, 5 mg per kg body weight, for 3 days. General laboratory variables were measured both at neonatal ICU admission and after intervention. All infants were studied with amplitude-integrated electroencephalography and brain MRI within the first week of life. The neurodevelopmental Bayley III test, the Gross Motor Function Classification System, and the Tardieu scale were applied at the ages of 6 and 18 months. MEASUREMENTS AND MAIN RESULTS: Clinical characteristics, laboratory evaluations, MRI findings, and amplitude-integrated electroencephalography background did not differ between the treatment groups. The newborns in the hypothermia plus melatonin group achieved a significantly higher composite score for the cognitive section of the Bayley III test at 18 months old, with respect to the hypothermia plus placebo group (p = 0.05). There were no differences between the groups according to the Gross Motor Function Classification System and Tardieu motor assessment scales. CONCLUSIONS: The early addition of IV melatonin to asphyctic neonates is feasible and may improve long-term neurodevelopment. To our knowledge, this is the first clinical trial to analyze the administration of IV melatonin as an adjuvant therapy to therapeutic hypothermia.

Prevention of syncytial respiratory virus infection with palivizumab: descriptive and comparative analysis after 12 years of use.

BACKGROUND: The use of palivizumab has been recommended to prevent syncytial respiratory virus (SRV) infection in vulnerable children. METHODS: We performed a retrospective study of hospital admissions for bronchiolitis from 2000 to 2012 in the context of a prevention study with palivizumab in at-risk newborns. RESULTS: A total of 952 children (59.5% males) were admitted due to bronchiolitis. Admissions occurred in younger children in the SRV+ cases compared to the SRV- cases (P<0.001). Additionally, 641 children were treated with Palivizumab at our service. Sixty of these children (9.8%) were admitted due to bronchiolitis and SRV was detected in 22 of them (3.4%). Fifty (7.8%) had underlying diseases, 6 (0.9%) presented with a history of perinatal infection and 20 (3.12%) had been part of a multiple birth. The treated children with some additional risk factor presented a greater risk of admission due to bronchiolitis (OR=1.99, P=0.045); however, this was not observed for admissions due to SRV (P=0.945). CONCLUSIONS: Children treated with Palivizumab showed a lower rate of SRV infection, despite having more risk factors associated with a higher risk of infection or complications.

Validation of a Portable Coagulometer for Routine In-Hospital Use for Newborns.

OBJECTIVES: To verify the reliability and clinical benefits of the coagulation tests made by a point of care device in newborn admitted to a neonatal unit. DESIGN: We made a statistical comparison between results obtained by the point of care device versus conventional laboratory analysis. SETTING: Level 3 neonatal unit. PATIENTS: Thirty-one infants admitted to the neonatal unit at the San Cecilio University Hospital (Granada, Spain) were recruited to this study. INTERVENTIONS: All underwent a double analytical determination: a small drop of blood was taken for analysis with a portable coagulometer (qLabs Electrometer Plus) and the rest of the blood sample was analyzed with conventional hospital laboratory equipment. MEASUREMENTS AND MAIN RESULTS: According to the linearity test performed, the measuring methods presented a good linear regression fit. Lin's concordance coefficient showed a "good" agreement for activated partial prothrombin time and international normalized ratio (>0.61) and a moderate one for prothrombin time (0.41-0.6) for the sample of newborns. CONCLUSIONS: The portable coagulometer qLabs Electrometer Plus device has the potential to be an alternative to standard hospital coagulation autoanalyzers in a subset of patients where the amount of blood drawn can have significant risks. Our study is the first of its kind to analyze the use of this device with severely ill newborns.

Epidemiological factors involved in the development of bronchopulmonary dysplasia in very low birth-weight preterm infants.

BACKGROUND: In spite of the advances made in perinatal medicine, the incidence of bronchopulmonary dysplasia (BPD) has not decreased and the aetiopathogenesis of the "new" BPD is still a matter for debate. The objectives of the present study were to analyse the epidemiological factors and morbidity associated with the development of BPD in a cohort of very low birth-weight (VLBW) preterm infants. METHODS: This retrospective observational study included all the preterm infants with birth weight ≤1500 g who were admitted to a tertiary-level hospital NICU from 2008 to 2011. A neurological follow-up was also carried out during the first two years of life. RESULTS: A total of 140 VLBW infants were analyzed: 28.4% presented oxygen dependence at 28 days, and 17.2% at 36 weeks adjusted gestational age. Predictive factors for the development of BPD were gestational age, birth weight, number of days of parenteral nutrition, number of days to achieve full enteral feeding, number of transfusions, duration of respiratory support and insulin administration, vasoactive drugs, diuretics, sedoanalgesia and postnatal corticosteroids. The neonatal morbidity associated with the development of BPD was late neonatal sepsis, patent ductus arteriosus, retinopathy of prematurity (ROP) and intraventricular hemorrhage. Non-significant associations with neurodevelopmental impairment were observed. CONCLUSIONS: Predictive factors for the development of BPD were respiratory support, feeding and different types of medication. Moreover, patients with BPD had a higher associated morbidity than those who did not develop BPD.

Nutrition in extremely low birth weight infants: impact on bronchopulmonary dysplasia.

BACKGROUND: Bronchopulmonary dysplasia (BPD) is a chronic lung disease that affects premature infants with multifactorial etiology. Some authors have considered malnutrition to be a major factor promoting BDP. The aim of our study was to examine the contribution of enteral and parenteral nutritional intake in the first 14 days of life to the development of bronchopulmonary dysplasia in a sample of preterm infants. METHODS: A prospective cohort study was conducted on all preterm infants born between 1 January 2008 and 31 December 2013. The nutritional parameters compiled included the cumulative amount of fluids, calories, proteins, carbohydrates and lipids consumed. Statistical analysis of the data consisted of a descriptive analysis, Mann-Whitney pairwise comparison test and logistic regression. RESULTS: The total caloric intake in the infants studied was significantly lower in patients with subsequent bronchopulmonary dysplasia (76.1 kCal/kg, 95% CI: 71.2-81.1 vs. 91.1 kCal/kg, 95% CI: 87.5-94.8). The intake of carbohydrate and fat was significantly lower in the patients with BPD (11.6 g/kg, 95% CI: 11.1-12.0 vs. 12.6 g/kg, 95% CI: 12.1-13; and 2.5 g/kg, 95% CI: 2.3-2.7 vs. 3.4 g/kg, 95% CI: 2.9-3.9, respectively). CONCLUSIONS: Our study shows that infants who develop bronchopulmonary dysplasia receive a lower enteral intake of calories and total lipids during the first 14 days of life.

Procalcitonin is not sufficiently reliable to be the sole marker of neonatal sepsis of nosocomial origin.

BACKGROUND: It has recently been suggested that serum procalcitonin (PCT) is of value in the diagnosis of neonatal sepsis, with varying results. The aim of this prospective multicenter study was to assess the usefulness of PCT as a marker of neonatal sepsis of nosocomial origin. METHODS: One hundred infants aged between 4 and 28 days of life admitted to the Neonatology Services of 13 acute-care teaching hospitals in Spain over 1-year with clinical suspicion of neonatal sepsis of nosocomial origin were included in the study. Serum PCT concentrations were determined by a specific immunoluminometric assay. The reliability of PCT for the diagnosis of nosocomial neonatal sepsis at the time of suspicion of infection and at 12-24 h and 36-48 h after the onset of symptoms was calculated by receiver-operating characteristics (ROC) curves. The Youden's index (sensitivity + specificity - 1) was used for determination of optimal cutoff values of the diagnostic tests in the different postnatal periods. Sensitivity, specificity, and the likelihood ratio of a positive and negative result with the 95% confidence interval (CI) were calculated. RESULTS: The diagnosis of nosocomial sepsis was confirmed in 61 neonates. Serum PCT concentrations were significantly higher at initial suspicion and at 12-24 h and 36-48 h after the onset of symptoms in neonates with confirmed sepsis than in neonates with clinically suspected but not confirmed sepsis. Optimal PCT thresholds according to ROC curves were 0.59 ng/mL at the time of suspicion of sepsis (sensitivity 81.4%, specificity 80.6%); 1.34 ng/mL within 12-24 h of birth (sensitivity 73.7%, specificity 80.6%), and 0.69 ng/mL within 36-48 h of birth (sensitivity 86.5%, specificity 72.7%). CONCLUSION: Serum PCT concentrations showed a moderate diagnostic reliability for the detection of nosocomial neonatal sepsis from the time of suspicion of infection. PCT is not sufficiently reliable to be the sole marker of sepsis, but would be useful as part of a full sepsis evaluation.