Project description:BackgroundCholestasis is a common but serious clinical condition in preterm neonates. The current management for preterm neonatal cholestasis has limitations. The aim of this study was to determine effects of Bifidobacterium supplementation on the prevention and alleviation of cholestasis in preterm infants with very low birth weight.MethodsPreterm neonates with very low birth weight were enrolled in the Children's Hospital of Soochow University between December 2012 and December 2017. The patients were randomly assigned into Bifidobacterium and control groups, and effects of Bifidobacterium supplementation on the outcomes were compared between the two groups.ResultsThere was no significant difference in the baseline characteristics in the two groups. Notably, the proportion of cases with neonatal cholestasis was significantly lower, with fewer neonatal cholestasis-associated complications in the Bifidobacterium group compared with the control group (6% versus 22%, P < 0.01). Furthermore, the Bifidobacterium group exhibited less severe cholestasis and better improvement of the liver function than the control group as evidenced by the biochemical tests (P < 0.01). Furthermore, the Bifidobacterium group exhibited less severe cholestasis and better improvement of the liver function than the control group as evidenced by the biochemical tests (P < 0.01). Furthermore, the Bifidobacterium group exhibited less severe cholestasis and better improvement of the liver function than the control group as evidenced by the biochemical tests (days, P < 0.01). Furthermore, the Bifidobacterium group exhibited less severe cholestasis and better improvement of the liver function than the control group as evidenced by the biochemical tests (P < 0.01). Furthermore, the Bifidobacterium group exhibited less severe cholestasis and better improvement of the liver function than the control group as evidenced by the biochemical tests (P < 0.01). Furthermore, the Bifidobacterium group exhibited less severe cholestasis and better improvement of the liver function than the control group as evidenced by the biochemical tests (P < 0.01). Furthermore, the Bifidobacterium group exhibited less severe cholestasis and better improvement of the liver function than the control group as evidenced by the biochemical tests (P < 0.01). Furthermore, the Bifidobacterium group exhibited less severe cholestasis and better improvement of the liver function than the control group as evidenced by the biochemical tests (.ConclusionsBifidobacterium supplementation has significantly preventive and other beneficial effects on the management of cholestasis in preterm infants with very low birth weight. Its long-term safety and effectiveness will need further investigation. This trial is registered with the Chinese Clinical Trial Registry (Registration No. ChiCTR1900022296).
Project description:BackgroundSmall for gestational age neonates have a higher risk of growth delay. The purpose of the study is to determine if there are differences in their early weight gain patterns that persist after adjusting for confounding variables.MethodsTwo-hundred sixteen neonates born between 1999 and 2003 were included. The group for analysis was derived by matching all the SGA infants with AGA infants by sex, year of birth, and birth weight. The period of observation was from birth to date of discharge. Weight gain rate was defined as grams gained per kilogram of birth weight per day. Two sample T-test was used to determine the difference in growth rate between the groups. Simple regression was used to establish the effect of morbidities on weight gain rate.ResultsThe total mean birth weight was 1105 g (+/- 223 g), the mean gestational age was 30 weeks (+/- 2.7 weeks), and the mean weight gain rate was 13.4 g/kg/d (+/- 6.8 g/kg/d). The mean weight gain rate for the adequate for gestational age group was lower (11.9 g/kg/d +/- 7.6g versus 14.9 g/kg/d +/- 5.5 g) (P < 0.001). When all variables were analyzed using the lineal regression model, only having a low APGAR score (P = 0.02) and being small for gestational age (P = 0.0004) were significant.ConclusionsWe conclude that the growth patterns of very low birth weight neonates are different based on the adequacy of their birth weight, and that the disparity in growth rate is not explained by the differences in the incidence of morbidities that affect growth.
Project description:Despite recommendations promoting noninvasive delivery room (DR) ventilation, local historical preterm DR noninvasive ventilation rates were low (50%-64%). Project aims were to improve DR noninvasive ventilation rate in very low birth weight (VLBW) neonates (<1500 g) with a focus on decreasing DR intubations for ineffective positive pressure ventilation (PPV).MethodsWe addressed drivers for improving noninvasive ventilation and decreasing intubations for ineffective PPV through plan-do-study-act cycles. Outcome measures were intubation for ineffective PPV (defined as intubation for heart rate <100 despite ongoing PPV) and final respiratory support in the DR. Our process measure was adherence to division-wide DR-intubation guidelines. Balancing measures were maximum FiO2 and hypothermia. We analyzed data using statistical process control charts and special cause variation rules.ResultsThere were 139 DR intubations among 521 VLBW neonates between January 2015 and February 2020. The noninvasive ventilation rate upon intensive care nursery admission was higher than historically reported at 73% and sustained throughout the project. The intubation rate for ineffective PPV was 10% and did not change. The number of VLBW neonates between intubations for ineffective PPV increased from 6.1 to 8.0. Ten intubations did not comply with guidelines. Balancing measures were unaffected.ConclusionsNoninvasive ventilation rates were higher than historically reported and remained high. After plan-do-study-act cycles, the number of VLBW neonates between intubations for ineffective PPV increased without impacting balancing measures. Our data demonstrate that effective ventilation (heart rate > 100) using noninvasive support is possible in up to 90% of VLBW infants but requires ongoing PPV training.
Project description:ObjectivePredictive models for preterm infant mortality have been developed internationally, albeit not valid for all populations. This study aimed to develop and validate different mortality predictive models, using Spanish data, to be applicable to centers with similar morbidity and mortality.MethodsInfants born alive, admitted to NICU (BW<1500 g or GA<30 w), and registered in the SEN1500 database, were included. There were two time periods; development of the predictive models (2009-2012) and validation (2013-2015). Three models were produced; prenatal (1), first 24 hours of life (2), and whilst admitted (3). For the statistical analysis, hospital mortality was the dependent variable. Significant variables were used in multivariable regression models. Specificity, sensitivity, accuracy, and area under the curve (AUC), for all models, were calculated.ResultsOut of 14953 included newborns, 2015 died; 373 (18.5%) in their first 24 hours, 1315 (65.3%) during the first month, and 327 (16.2%) thereafter, before discharge. In the development stage, mortality prediction AUC was 0.834 (95% CI: 0.822-0.846) (p<0.001) in model 1 and 0.872 (95% CI: 0.860-0.884) (p<0.001) in model 2. Model 3's AUC was 0.989 (95% CI: 0.983-0.996) (p<0.001) and 0.942 (95% CI: 0.929-0.956) (p<0.001) during the 0-30 and >30 days of life, respectively. During validation, models 1 and 2 showed moderate concordance, whilst that of model 3 was good.ConclusionUsing dynamic models to predict individual mortality can improve outcome estimations. Development of models in the prenatal period, first 24 hours, and during hospital admission, cover key stages of mortality prediction in preterm infants.
Project description:Prolonged infusion of meropenem has been suggested in studies with population pharmacokinetic modeling but has not been tested in neonates. We compared the steady-state pharmacokinetics (PK) of meropenem given as a short (30-min) or prolonged (4-h) infusion to very-low-birth-weight (gestational age, <32 weeks; birth weight, <1,200 g) neonates to define the appropriate dosing regimen for a phase 3 efficacy study. Short (n = 9) or prolonged (n = 10) infusions of meropenem were given at a dose of 20 mg/kg every 12 h. Immediately before and 0.5, 1.5, 4, 8, and 12 h after the 4th to 7th doses of meropenem, blood samples were collected. Meropenem concentrations were measured by ultrahigh-performance liquid chromatography. PK analysis was performed with WinNonlin software, and modeling was performed with NONMEM software. A short infusion resulted in a higher mean drug concentration in serum (C(max)) than a prolonged infusion (89 versus 54 mg/liter). In all but two patients in the prolonged-infusion group, the free serum drug concentration was above the MIC (2 mg/liter) 100% of the time. Meropenem clearance (CL) was not influenced by postnatal or postmenstrual age. In population PK analysis, a one-compartment model provided the best fit and the steady-state distribution volume (V(ss)) was scaled with body weight and CL with a published renal maturation function. The covariates serum creatinine and postnatal and gestational ages did not improve the model fit. The final parameter estimates were a V(ss) of 0.301 liter/kg and a CL of 0.061 liter/h/kg. Meropenem infusions of 30 min are acceptable as they balance a reasonably high C(max) with convenience of dosing. In very-low-birth-weight neonates, no dosing adjustment is needed over the first month of life.
Project description:OBJECTIVE:To evaluate the combined prognostic value of neurological examination, head circumference and cranial ultrasound for neurodevelopmental delay (NDD) in very low birth weight (VLBW, <1500 g) preterm infants. METHODS:Prospective follow-up study. Preterm infants with VLWB were assessed for NDD using the Mullen Scales of Early Learning test at 24 months of corrected age. Abnormal neurological examination (≥2 deviant items of Hammersmith neurological examination), microcephaly and major ultrasound abnormalities, each performed at term age, were evaluated as predictors of NDD in a multivariable Poisson model. RESULTS:35/132 infants (26.5%) had NDD. In the multivariable analysis, microcephaly (RR, 3.2; 95% CI, 1.6-6.7) and major ultrasound abnormalities (RR, 2.7; 95% CI, 1.3-5.7) were associated to NDD. The combination of the two tests showed the highest positive predictive value (100%; 95% CI, 51%-100%), while the combination of normal neurological examination, no major US findings and normal head size at term showed the highest negative predictive value (89%; 95% CI, 78%-95%). The maximum under receiver operating characteristic curve area was for microcephaly or major ultrasound abnormalities (AUC 0.74 (0.65-0.83)). CONCLUSION:The combination of head circumference, cranial ultrasound and neurological examination at term age is useful to predict NDD in VLBW preterm infants.
Project description:BACKGROUND:Inhaled corticosteroids (ICS) offer targeted treatment for bronchopulmonary dysplasia (BPD) with minimal systemic effects compared to systemic steroids. However, dosing of ICS in the management of infants at high-risk of developing BPD is not well established. The objective of this study was to determine an effective dose of ICS for the treatment of ventilator-dependent infants to facilitate extubation or reduce fractional inspired oxygen concentration. METHODS:Forty-one infants born at < 32 weeks gestational age (GA) or < 1250 g who were ventilator-dependent at 10-28 days postnatal age were included. A non-randomized dose-ranging trial was performed using aerosolized inhaled beclomethasone with hydrofluoralkane propellant (HFA-BDP). Four dosing groups (200, 400, 600 and 800 μg twice daily for 1 week) with 11, 11, 10 and 9 infants in each group, respectively, were studied. The primary outcome was therapeutic efficacy (successful extubation or reduction in FiO2 of > 75% from baseline) in ≥60% of infants in the group. Oxygen requirements, complications and long-term neurodevelopmental outcomes were also assessed. RESULTS:The median age at enrollment was 22 (10-28) postnatal days. The primary outcome, therapeutic efficacy as defined above, was not achieved in any group. However, there was a significant reduction in post-treatment FiO2 at a dose of 800 μg bid. No obvious trends were seen in long-term neurodevelopmental outcomes. CONCLUSIONS:Therapeutic efficacy was not achieved with all studied doses of ICS. A significant reduction in oxygen requirements was noted in ventilator-dependent preterm infants at 10-28 days of age when given 800 μg of HFA-BDP bid. Larger randomized trials of ICS are required to determine efficacy for the management of infants at high-risk for development of BPD. TRIAL REGISTRATION:This clinical trial was registered retrospectively on clinicaltrials.gov. The registration number is NCT03503994 .