Study of Early Predictors of Fatality in Mechanically Ventilated Neonates in NICU

Objective: To evaluate the risk factors associated with fatality in mechanically ventilated neonates using multiple regression analysis. Design & settings: Prospective study conducted at Neonatal ICU at New Civil Hospital, Surat – a tertiary care centre, from December, 2007 to May, 2008 for 6 months. Methods: Fifty neonates in NICU consecutively put on mechanical ventilator during study period were enrolled in the study. The pressure limited time cycled ventilator was used. All admitted neonates were subjected to an arterial blood gas analysis along with a set of investigations to look for pulmonary maturity, infections, renal function, hyperbilirubinemia, intraventricular hemorrhage and congenital anomalies. Different investigation facilities were used as and when required during ventilation of neonates. Multiple logistic regression analysis was done to find out the predictors of fatality among these neonates. Results: Various factors suspected as predictors of fatality of mechanically ventilated neonates were assessed. Hypothermia, prolonged capillary refill time (CRT), initial requirement of oxygen fraction (FiO2) >0.6, alveolar to arterial PO2 difference (AaDO2) >250, alveolar to arterial PO2 ratio (a/A) <0.25, & oxygenation index (OI) >10 were found statistically highly significant predictors of mortality among mechanically ventilated neonates. Conclusion: Hypothermia and prolonged capillary refill time were independent predictors of fatality in neonatal mechanical ventilation. Risk of fatality can be identified in mechanically ventilated neonates

Neonatal Safety Information Reported to the FDA During Drug Development Studies.

BACKGROUND: Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the population and the level of illness. The objective of this study was to examine neonatal safety data submitted to the FDA in studies pursuant to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) between 1998 and 2015. METHODS: FDA databases were searched for BPCA and/or PREA studies that enrolled neonates. Studies that enrolled a minimum of 3 neonates were analyzed for the presence and content of neonatal safety data. RESULTS: The analysis identified 40 drugs that were studied in 3 or more neonates. Of the 40 drugs, 36 drugs received a pediatric labeling change as a result of studies between 1998 and 2015, that included information from studies including neonates. Fourteen drugs were approved for use in neonates. Clinical trials for 20 of the drugs reported serious adverse events (SAEs) in neonates. The SAEs primarily involved cardiovascular events such as bradycardia and/or hypotension or laboratory abnormalities such as anemia, neutropenia, and electrolyte disturbances. Deaths were reported during studies of 9 drugs. CONCLUSIONS: Our analysis revealed that SAEs were reported in studies involving 20 of the 40 drugs evaluated in neonates, with deaths identified in 9 of those studies. Patients enrolled in studies were often critically ill, which complicated determination of whether an adverse event was drug-related. We conclude that the traditional means for collecting safety information in drug development trials needs to be adjusted for neonates and will require the collaboration of regulators, industry, and the clinical and research communities to establish appropriate definitions and reporting strategies for the neonatal population

Prevalence and Immediate Outcomes of Hypoxic Ischaemic Encephalopathy (HIE) Among Infants with Birth Asphyxia Admitted at the Neonatal ward of Muhimbili National Hospital in Dar es Salaam, Tanzania

\ud To determine the prevalence and immediate outcome of infant with hypoxic ischemic encephalopathy (HIE) admitted at the Neonatal ward [ward 36] of Muhimbili National Hospital. Prospective cohort hospital based study at the neonatal unit of Muhimbili National Hospital (MNH). It involved neonates with either low apgar score (score≤ 7 at 5 minutes) and/or those young infants that were found to have symptoms and signs suggestive of HIE. Data were collected using a checklist, and analysed using Epi-info computer program. The study showed the prevalence of birth asphyxia at neonatal ward MNH to be 30.9% and among these, 92 neonates (82.1%) had HIE. Mortality due to HIE was 27.2%. Majority of neonates with mild HIE (92.3%) was discharged to their mothers while majority of those with severe HIE (51.6%) died. A total of 92 neonates were recruited in the study. The prevalence of birth asphyxia at the Neonatal ward MNH from 13th may to 31st may 2007 was 30.9%.h 27.2%. 92.3% of neonates with Mild HIE discharged within seven (7) days while more than half those with severe HIE (51.3%) died and 72% of deaths occurred within first three (3) days of life. Also the less the severity of HIE the less time of stay in the ward and the earlier the neonates started breastfeeding while the vise versa is true. HIE score chart is simple to use and its correct use can predict the prognosis of the neonates with HIE\u

A comparison of Clinical Risk Index for babies (CRIB-II), Score for Neonatal Acute Physiology (SNAP-II) and SNAPPE-II in predicting parenteral nutrition necessity in low birth weight preterm neonates.

Advances in perinatal care have made it possible to improve survival of low birth weight neonates. Clinical risk index for babies (CRIB-II), score for neonatal acute physiology (SNAP-II), and SNAP-perinatal extension-II (SNAPPE-II) have been used as mortality predictors for preterm infants. Feeding intolerance is very frequent in preterm neonates, and the development of an early effective biomarker for its prediction could be useful for carrying out a proper feeding strategy. Our aim was to compare the ability of CRIB-II, SNAP-II and SNAPPE-II in predict the feeding intolerance and parenteral nutrition necessity in preterm neonates. Methods: A retrospective cohort study on preterm neonates’ born at Jaen Hospital Complex with low birth weight and ≤ 36 weeks of gestation was done. Epidemiological, clinical and clinical scores CRIB II, SNAP-II and SNAPPE-II were recorded. Results: 255 low birth weight preterm neonates, 131 males (51.4%), aged ≤32 weeks of gestation (71%), were enrolled at our hospital. Parenteral nutrition needed were significantly higher in preterm neonates weighed 2500-1500 g (73.3%) and ≤ 1000g (87%). CRIB-II, SNAP-II and SNAPPE-II mean values were higher in neonates group subjected to parenteral nutrition compared with oral nutrition (p<0.05). CRIB-II and SNAPPE-II scores significantly correlated with parenteral nutrition days (p<0.05). Overall mortality rate was 11%. The 78.6% of all deceased infants needed parenteral nutrition. Conclusion: Clinical Risk Index for babies (CRIB-II) better than SNAPPE-II correlated with the feeding intolerance and thus the parenteral nutrition days in preterm neonates with low birth weight.Subvencionado: Ayuda del Plan Propio de Investigación de la UMA. Universidad de Málaga. Campus de Excelencia Internacional Andalucía Tech

Is 24 hour observation in hospital after stopping intravenous antibiotics in neonates justified?

Background: Antibiotics are given empirically for suspected sepsis in up to 75% of neonates on the Neonatal and Paediatric Intensive Care Unit (NPICU), after completion of a septic screen. Treatment is discontinued on day 3 if cultures remain negative or after 7-14 days with proven sepsis and, until recently, these neonates are then observed for an additional period of 24 hours before being discharged from hospital. Aim: To assess whether the 24 hour observation period after stopping antibiotics is clinically justified and, if not, whether neonates can be discharged safely on the same day when antibiotics are stopped. Methods: A consecutive sample of 95 babies admitted to NPICU, and who received antibiotics, from December 2006 to January 2008 were analysed prospectively. Their clinical presentation, predisposing risk factors for neonatal sepsis, investigations, antibiotic details and medical management including respiratory support were recorded, and correlated with all events that may have occurred during the observation period after stopping antibiotics. Results: No adverse events were documented in the 24 hour period after antibiotics in all 95 neonates in this study and, therefore, there was no association with any potential predisposing risk factors. Conclusion: The need to observe neonates for a period prior to discharge after stopping antibiotics is not supported on clinical grounds and, as a result of this study, has been discontinued. Neonates can be discharged from hospital safely and immediately on stopping antibiotics, thus reducing hospital stay and an estimated cost saving of approximately €18,000 to the service provider per annum.peer-reviewe

Short-Term Neurodevelopmental Outcome in Term Neonates Treated with Phenobarbital versus Levetiracetam: A Single-Center Experience

BACKGROUND: Phenobarbital (PB) has been traditionally used as the first-line treatment for neonatal seizures. More recently, levetiracetam (LEV) has been increasingly used as a promising newer antiepileptic medication for treatment of seizures in neonates. OBJECTIVES: The aim of our study was to compare the effect of PB vs. LEV on short-term neurodevelopmental outcome in infants treated for neonatal seizures. METHOD: This randomized, one-blind prospective study was conducted on term neonates admitted to the Neonatal Intensive Care Unit of S. Bambino Hospital, University Hospital "Policlinico-Vittorio Emanuele," Catania, Italy, from February 2016 to February 2018. Thirty term neonates with seizures were randomized to receive PB or LEV; the Hammersmith Neonatal Neurological Examination (HNNE) was used at baseline (T0) and again one month after the initial treatment (T1). RESULTS: We found a significantly positive HNNE score for the developmental outcomes, specifically tone and posture, in neonates treated with LEV. There was no significant improvement in the HNNE score at T1 in the neonates treated with PB. CONCLUSION: This study suggests a positive effect of levetiracetam on tone and posture in term newborns treated for neonatal seizures. If future randomized-controlled studies also show better efficacy of LEV in the treatment of neonatal seizures, LEV might potentially be considered as the first-line anticonvulsant in this age grou

Serum Hsp70 antigen: Early diagnosis marker in perinatal asphyxia

BACKGROUND: Perinatal asphyxia is an important cause of mortality and permanent neurological and developmental deficit. Early and accurate diagnosis would help to establish the likely prognosis and may also help in determining the most appropriate treatment. Studies in experimental animal models suggest that a protein called Hsp70 may be a good and potentially useful marker of cellular stress that may be clinically useful in determining the presence of neonatal asphyxia. OBJECTIVES: Regarding the importance of early and accurate diagnosis of asphyxia, we conducted this study, which is the first investigation of the comparison of the serum Hsp70 antigen level between asphyxiated and healthy infants. PATIENTS AND METHODS: In this observational study, the serum concentrations of Hsp70 antigen were compared between neonates suffering from perinatal asphyxia (n = 50) and normal neonates (n = 51). The inclusion criteria for the cases were neonates who had reached term and had at least two clinical criteria of asphyxia. Exclusion criteria were babies with gestational age < 37 weeks, infants with congenital abnormalities or positive blood culture. Exclusion criteria in this group were the requirement to hospital stay during first week of the life or babies whose mothers had difficulties during pregnancy or delivery. Term neonates without major anomalies who had asphyxia during delivery were enrolled in the first six hours after delivery, and control group consisted of healthy term neonates without problems and normal delivery process in the first week of life. The cord blood was taken during labor to measure Hsp70 antigen level by using an in-house ELISA (The enzyme-linked immunosorbent assay). RESULTS: The median values of serum anti Hsp70 titers were significantly higher in asphyxiated neonates compared with non-asphyxiated neonates (0.36 [0.04 - 1.14] vs 0.24 [0.01 - 0.63]). At cutoff point = 0.3125 ng/mL, sensitivity was 58% and specificity 76% based on ROC curve. CONCLUSIONS: A significant difference between the serum concentrations of Hsp70 of the control and patient group was observed in this study. It is inferred serum concentrations of Hsp70 antigen may be a useful marker for the early diagnosis of that prenatal hypoxia

Endocardial Pacemaker Implantation in Neonates and Infants

Transvenous pacemaker lead implantation is the preferred method of pacing in adult patients. Lead performance and longevity are superior and the implantation approach can be performed under local anaesthetic with a very low morbidity. In children, and especially in neonates and infants, the epicardial route was traditionally chosen until the advent of smaller generators and lead implantation techniques that allowed growth of the child without lead displacement. Endocardial implantation is not universally accepted, however, as there is an incidence of venous occlusion of the smaller veins of neonates and infants with concerns for loss of venous access in the future. Growing experience with lower profile leads, however, reveals that endocardial pacing too can be performed with low morbidity and good long-term results in neonates and infants

New architectural design of delivery room reduces morbidity in preterm neonates: a prospective cohort study

Background: A multidisciplinary committee composed of a panel of experts, including a member of the American Academy of Pediatrics and American Institute of Architects, has suggested that the delivery room (DR) and the neonatal intensive care units (NICU) room should be directly interconnected. We aimed to investigate the impact of the architectural design of the DR and the NICU on neonatal outcome. Methods: Two cohorts of preterm neonates born at < 32weeks of gestational age, consecutively observed during 2years, were compared prospectively before (Cohort 1: "conventional DR") and after architectural renovation of the DR realized in accordance with specific standards (Cohort 2: "new concept of DR"). In Cohort 1, neonates were initially cared for a conventional resuscitation area, situated in the DR, and then transferred to the NICU, located on a separate floor of the same hospital. In Cohort 2 neonates were assisted at birth directly in the NICU room, which was directly connected to the DR via a pass-through door. The primary outcome of the study was morbidity, defined by the proportion of neonates with at least one complication of prematurity (i.e., late-onset sepsis, patent ductus arteriosus, intraventricular hemorrhage, periventricular leukomalacia, bronchopulmonary dysplasia, retinopathy of prematurity and necrotizing enterocolitis). Secondary outcomes were mortality and duration of hospitalization. Statistical analysis was performed using standard methods by SPSS software. Results: We enrolled 106 neonates (56 in Cohort 1 and 50 in Cohort 2). The main clinical and demographic characteristics of the 2cohorts were similar. Moderate hypothermia (body temperature ≤ 35.9° C) was more frequent in Cohort 1 (57%) compared with Cohort 2 (24%, p = 0.001). Morbidity was increased in Cohort 1 (73%) compared with Cohort 2 (44%, p = 0.002). No statistically significant differences in mortality and median duration of hospitalization were observed between the 2 cohorts of the study. Conclusions: If realized according to the proposed architectural standards, renovation of DR and NICU may represent an opportunity to reduce morbidity in preterm neonates

Assessment of the incidence of sensorineural hearing loss among infants admitted to neonatal intensive care unit in health centers of Golestan University of Medical Sciences, Iran

Materials and methods: In this prospective cohort study, 870 neonates were recruited by nonrandom sampling method. After filling in the demographic and clinical check lists, automated auditory brainstem response (AABR) was performed for neonates at the beginning of hospitalization; then they were followed-up and again they were assessed with AABR and for those babies who had abnormal AABR, auditory brainstem response (ABR) was performed before discharge at the same day