Early Clinical Parameters Research Articles

Provision of bubble continuous positive airway pressure for the stabilisation of extremely and very preterm infants after birth: A single-centre experience.

To describe the effect of resuscitation with bubble CPAP (bCPAP) versus T-piece device at birth on early clinical parameters and hospital outcomes in infants born <32 weeks gestation. This is a single-centre pre- and post-implementation study comparing outcomes in two epochs. In epoch 1 (1 July 2013-31 December 2014), infants were managed with non-humidified gas using Neopuff® T-piece devices to support breathing after birth. In epoch 2 (1 March 2020-31 December 2021), routine application of bCPAP with humidified gas was introduced at birth. Three hundred fifty-seven patients were included (176 epoch 1, 181 epoch 2). The mean gestational age was 28 ± 2 weeks. The demographics of the two epochs were comparable. There were significant improvements in outcomes of infants in epoch 2 with less infants intubated at delivery (16% vs. 4%, P ≤ 0.001), improved 5 min Apgar (7 vs. 8, P ≤ 0.001), reduced need for ventilation (21% vs. 8.8%, P ≤ 0.001), duration of ventilation in the first 72 h (9.6 vs. 4.6 h) and mortality (10.8% vs. 1.7%, P ≤ 0.001). There was, increased incidence of chronic lung disease (30% vs. 55%, P = 0.02) but no increase in infants discharged on oxygen (3.8% vs. 5%, P = 0.25). Similar findings were observed in a subgroup of infants born <25 weeks' gestation with no increase in the incidence of CLD. Introducing application of bCPAP from the first breaths in infants <32 weeks' gestation was associated with better short-term outcomes and mortality, albeit with increased incidence of CLD. The subgroup of infants born <25 weeks' gestation showed similar change in outcomes, with no increase in CLD.

The RAPID-score: Risk Assessment and PredIction of Delirium in acute stroke patients based on very early clinical parameters.

Post-stroke delirium (PSD) is a common complication in acute stroke patients, and guidelines recommend routine screening and various preventive and treatment measures. However, there is a substantial lack of standardized approaches in diagnostic and therapeutic management of PSD. Here, we aimed to develop a new pragmatic and easily assessable screening tool to predict PSD based on early parameters, which are already integral to acute stroke diagnostics. We enrolled acute stroke patients admitted to our stroke unit or intensive care unit and developed the scoring system using retrospective single-center patient data. The Confusion Assessment Method for the Intensive Care Unit was used for prospective score validation. Logistic regression models were employed to analyze the association of early clinical and paraclinical parameters with PSD development. N = 525 patients (median age: 76 years; 45.7% female) were enrolled, with 29.7% developing PSD during hospitalization. The resulting score comprises 6 items, including medical history, clinical examination findings, and non-contrast computed tomography results at admission. Scores range from -15 to +15 points, with higher values indicating a higher likelihood of PSD, ranging from 4% to 79%. The accuracy was 0.85, and the area under the curve was 0.89. The new RAPID (Risk Assessment and PredIction of Delirium in acute stroke patients)-score shows high accuracy in predicting PSD among acute stroke patients and offers precise odds of PSD for each corresponding score value, utilizing routine early clinical and paraclinical parameters. It can identify high-risk populations for clinical study interventions and may be suitable to guide prophylactic PSD measures.

A predictive value of early clinical parameters for abnormal brain MRI scan in neonates treated with therapeutic hypothermia

Introduction:Brain MRI scans can predict neurodevelopmental outcomes in neonates treated with therapeutic hypothermia. It is a common clinical practice to perform brain MRI before discharge, but brain MRI scans performed at around four months of age have a better prognostic value for a long-term neurological outcome in asphyxiated neonates. Aim: To identify which of three selected clinical parameters (oral feeding ability, muscle tone, history of seizure) evaluated 10 days after therapeutic hypothermia could predict the primary outcome of an abnormal brain MRI. Methods: We reviewed the medical records of neonates ≥ 36 completed weeks of gestation consecutively treated with therapeutic hypothermia who underwent brain MRI. Clinical parameters on day 10 after therapeutic hypothermia were correlated with brain MRI findings in the first 7-14 days of life. Logic regression analysis was performed using all three covariates of the clinical status, with an abnormal MRI as the primary outcome. Results: Brain MRI was abnormal in 42 (51.85 %) neonates with the following distribution of brain injury patterns: abnormal signal in the basal nuclei in 6, an abnormal signal in the cortex in 16, an abnormal signal both in the cortex and basal nuclei in 20 neonates. Out of three analyzed clinical parameters, feeding difficulty (P &lt; 0.001, OR 8.3, 95% CI 2.9 - 28.9) and a history of seizures (P &lt; 0.001, OR 11.95, 95% CI 3 - 44.5) were significantly associated with an abnormal MRI. Conclusion: Neonates who were capable of full oral feeding by day 10 after therapeutic hypothermia and had no history of seizures were unlikely to have an abnormal MRI. This may be used in selective planning of pre-discharge MRI in asphyxiated neonates.

Clinical Features and Risk Factors for Mortality in Children With Acute Encephalitis Who Present to the Emergency Department.

Acute encephalitis is an important pediatric emergency that tends to be associated with neurological morbidity, critical illness, and mortality. Few data have specifically focused on evaluating various early clinical parameters in the pediatric emergency department as candidate predictors of mortality. The present retrospective study assessed the clinical, laboratory, and neuroimaging findings of children with acute encephalitis who presented to the emergency department. Of 158 patients diagnosed with encephalitis, 7 (4.4%) had mortality. Compared to the survivors, a multivariate analysis revealed that an initial Glasgow Coma Scale score ≤ 5 (odds ratio [OR]: 8.3, P = .022), acute necrotizing encephalitis (OR: 12.1, P = .01), white blood count level ≤ 5.2 × 109 cells/L (OR: 28.7, P < .001), aspartate aminotransferase level > 35 U/L (OR: 14.3, P = .022), and influenza A infection (OR: 7.7, P = .027) were significantly associated with mortality. These results indicate that the early recognition of preliminary clinical features and the development of more specific etiologies for encephalitis are important for early treatment strategies.

Use of Growth Hormone in the IVF Treatment of Women With Poor Ovarian Reserve

Growth hormone (GH) has been used as an adjunct in the field of female infertility treatment for more than 25 years, although, apart from treating women with GH deficiency its role has not yet been clarified. Contributing to this lack of clarity is that several underpowered studies have been performed on women undergoing IVF treatment, with a previous “poor response” to ovarian stimulation, which have suggested a favorable outcome. Meta-analysis of randomized controlled trials has demonstrated a benefit for the use of the adjunct growth hormone, in comparison to placebo; with reductions in the duration of ovarian stimulation required prior to oocyte retrieval, with a greater number of oocytes collected, and improvements in many of the early clinical parameters with the use of GH. However, no benefit of an increased chance of a live birth with the use of growth hormone for the “poor responding” patient has been determined. Consequently the role of GH to treat a woman with a poor response to ovarian stimulation cannot be supported on the basis of the available evidence. However, the place for GH in the treatment of women undergoing IVF may yet still be determined, as it is also used, without firm evidence of benefit; for women with poor embryonic development, poor endometrial development and for women who do not conceive despite multiple embryo transfers (recurrent implantation failure).

Early Childhood Outcomes After Neonatal Encephalopathy in Uganda: A Cohort Study

BackgroundNeonatal encephalopathy (NE) is a leading cause of global child mortality. Survivor outcomes in low-resource settings are poorly described. We present early childhood outcomes after NE in Uganda. MethodsWe conducted a prospective cohort study of term-born infants with NE (n = 210) and a comparison group of term non-encephalopathic (non-NE) infants (n = 409), assessing neurodevelopmental impairment (NDI) and growth at 27–30 months. Relationships between early clinical parameters and later outcomes were summarised using risk ratios (RR). FindingsMortality by 27–30 months was 40·3% after NE and 3·8% in non-NE infants. Impairment-free survival occurred in 41·6% after NE and 98·7% of non-NE infants. Amongst NE survivors, 29·3% had NDI including 19·0% with cerebral palsy (CP), commonly bilateral spastic CP (64%); 10·3% had global developmental delay (GDD) without CP. CP was frequently associated with childhood seizures, vision and hearing loss and mortality. NDI was commonly associated with undernutrition (44·1% Z-score < −2) and microcephaly (32·4% Z-score < −2). Motor function scores were reduced in NE survivors without CP/GDD compared to non-NE infants (median difference −8·2 (95% confidence interval; −13·0, −3·7)). Neonatal clinical seizures (RR 4.1(2.0–8.7)), abnormalities on cranial ultrasound, (RR 7.0(3.8–16.3), nasogastric feeding at discharge (RR 3·6(2·1–6·1)), and small head circumference at one year (Z-score < −2, RR 4·9(2·9–5·6)) increased the risk of NDI. InterpretationIn this sub-Saharan African population, death and neurodevelopmental disability after NE were common. CP was associated with sensorineural impairment, malnutrition, seizures and high mortality by 2 years. Early clinical parameters predicted impairment outcomes.

The effect of intravenous tranexamic acid on blood loss and early post-operative pain in total shoulder arthroplasty.

The purpose of the present study was to evaluate the impact of intravenous tranexamic acid on the reduction of blood loss, transfusion rate, and early post-operative clinical outcome in total shoulder arthroplasty. A randomised, placebo-controlled trial which included 54 patients undergoing unilateral primary stemless anatomical or stemmed reverse total shoulder arthroplasty was undertaken. Patients received either 100 ml saline (placebo, n = 27), or 100 ml saline together with 1000 mg of tranexamic acid (TXA, n = 27) intravenously prior to skin incision and during wound closure. Peri-operative blood loss via an intra-articular drain was recorded and total blood loss was calculated. The post-operative transfusion rate was documented. Assessment of early clinical parameters included the visual analogue scale for pain (VAS), documentation of haematoma formation and adverse events. Mean peri-operative blood drainage (placebo: 170 ml versus TXA: 50 ml, p = 0.001) and calculated mean total blood loss (placebo: 1248.2 ml versus TXA: 871.0 ml, p = 0.009) were significantly lower in the TXA group. No transfusions were necessary during the study period in either group. Mean VAS for pain significantly decreased from pre-operative (VAS 7) to the early post-operative period (VAS 1.7, p < 0.001). Significant differences regarding mean post-operative pain between placebo (VAS 2.0) and TXA (VAS 1.3) were detected (p = 0.05). The occurrence of haematomas was significantly more frequent in the placebo (59.3%, n=16) than in the TXA group (25.9%, n = 6, p = 0.027). Whereas only mild haematomas developed in the TXA group, in the placebo group a total of 22.2% (n = 6) developed either moderate or severe haematomas. No adverse events associated with administration of TXA occurred. Intravenous administration of TXA successfully reduced mean peri-operative blood drainage, total estimated blood loss, pain during the first post-operative days, and haematoma formation in total shoulder arthroplasty. Cite this article: Bone Joint J 2017;99-B:1073-9.

Growth hormone in IVF cycles: any hope?

Growth hormone (GH) has been used as an adjunct in ovulation induction and IVF for 25 years, particularly as an adjunct to ovarian stimulation for women who had a previous poor response to stimulation in an IVF cycle. It does not have US Food and Drug Administration approval for this use. Unfortunately, due to the problems inherent with recruiting women who have undergone unsuccessful IVF treatment cycles and their inevitable low live birth rate per initiated cycle, many studies performed to date have been underpowered. Previous meta-analyses of studies performed in populations of women with a poor response to ovarian stimulation, demonstrated an increase in the live birth rate for the use of GH. With the recent publication of three studies and the presentation of the Australian LIGHT study, we undertook an updated meta-analysis. Meta-analysis demonstrated a benefit for the use of the adjunct GH, with a reduction in the duration of ovarian stimulation required for oocyte retrieval, the collection of a greater number of oocytes than placebo, and an improvement in many of the early clinical parameters; however, there was no evidence of an increased chance of a live birth for the use of GH.

Effects of Nebulized Albuterol in Transient Tachypnea of the Newborn A Clinical Trial

Background: To date there is no effective drug treatment for transient tachypnea of the newborn (TTN) and respiratory support is the only means to handle this disease. This study was performed to evaluate the effect of albuterol (Salbutamol) in improvement of respiratory distress in involved neonates. Methods: We conducted a randomized, blinded, placebo-controlled clinical trial Neonates with TTN received either nebulized albuterol (30 neonates) or placebo (30 neonates), and early clinical parameters were measured during and after treatment. Results: Totally 60 neonates including 31 males and 29 females, mean gestational age of 36.9 +/- 1.69 weeks, mean weight of 2703 +/- 589 gr, were analyzed. Respiratory distress score was significantly decreased in treatment compared to placebo group (from 5.6 at the start to 1.7 at the end of study vs 5.6 to 3.9 respectively) and the PO2 was significantly increased in neonates receiving nebulized albuterol compared to the placebo group (from 58.5 at the start to 84.8 at the end of study vs 58.2 to 70.2 respectively). No adverse effects were observed in either group. The duration of continuous positive airway pressure (CPAP) application was significantly decreased in the treatment group compared to the placebo group (1.6 +/- 0.77 vs. 3.3 +/- 0.98 respectively) (P = 0.0001). Conclusions: Application of nebulized albuterol caused a considerable improvement in the respiratory distress of neonates at its primary hour of using via reduction of respiratory scores, duration and concentration of oxygen requirement, and duration of CPAP without any side effects. Therefore, this drug can be applied in the treatment of Transient Tachypnea of the Newborn appropriately.

Tracheostomy in craniectomised survivors after traumatic brain injury: A cross-sectional analytical study

BackgroundDecompressive craniectomy (DC) is a life-saving measure for traumatic brain injury (TBI). However, survivors may remain in a vegetative or minimally conscious state and require tracheostomy to facilitate airway management. In this cross-sectional analytical study, we investigated the predictors for tracheostomy requirement and influence of tracheostomy timing on outcomes in craniectomised survivors after TBI. MethodsWe enrolled 160 patients undergoing DC and surviving >7 days after TBI in this 3-year retrospective study. The patients were subdivided into 2 groups based on whether tracheostomy was (N=38) or was not (N=122) performed. We identified intergroup differences in early clinical parameters. Multivariable logistic regression was used to adjust for independent predictors of the need for tracheostomy. Early tracheostomy was defined as the performance of the procedure within the first 10 days after DC. Intensive care unit (ICU) stay, hospital stay, mortality, and Glasgow outcome scale (GOS) were analysed according to the timing of the tracheostomy procedure. ResultsAfter TBI, 24% of craniectomised survivors required tracheostomy. In the multivariate logistic regression mode, the significant factors related to the need for tracheostomy were age (odds ratio=1.041; p=0.002), the Glasgow coma score (GCS) at admission (odds ratio=0.733; p=0.005), and normal status of basal cisterns (odds ratio=0.000; p=0.008). The ICU stay was shorter for patients with early tracheostomy than for those undergoing late tracheostomy (p=0.004). The timing of tracheostomy had no influence on the hospital stay, mortality, or GOS. ConclusionAge and admission GCS were independent predictors of the need for tracheostomy in craniectomised survivors after TBI. If tracheostomy is necessary, an earlier procedure may assist in patient care.

Elevated pretransplantation soluble CD30 is associated with decreased early allograft function after human lung transplantation

Early allograft function after lung transplantation is variable. Clinical criteria have limited predictive value for early graft function. Recipient immunologic state before LTx may affect early lung function. We investigated the association between pretransplantation soluble CD30 (sCD30), a marker of Th2-type T-cell activation, and early clinical parameters of allograft function. Between September 2002 and January 2007, a total of 80 transplantations were performed at Johns Hopkins Hospital. Of the patients, 43 had a pretransplantation sCD30 level determined. Pre- and postoperative patient variables were collected, and patients were stratified into two groups: sCD30 <20 (low sCD30) and >20 (high sCD30). High sCD30 ( n = 26) and low sCD30 ( n = 17) groups were similar in age, gender, and ischemia time. In the high sCD30 group, a higher percentage of patients had pulmonary fibrosis and a lower percentage had emphysema. Oxygenation at 48 hours was significantly worse in the high sCD30 group as compared with the low sCD30 ( p = 0.003). Moreover, prolonged intubation and 90-day mortality were greater in the high sCD30 group. This represents the first report of the use of sCD30 as a marker for early allograft function in human lung transplanation. Increased pretransplantation recipient sCD30 appears to be associated with decreased early post-transplantation gas exchange, prolonged intubation, and early mortality.

Response to one infusion predicts subsequent improvement as well as the rate of relapse of ankylosing spondylitis infused with three pulses of infliximab

The objective of this study was to evaluate if there are early clinical parameters in AS patients treated with three standard infusions of infliximab, which would predict whether a patient will derive a significant improvement at the tenth week, or whether there will be a lengthy clinical response after discontinuing the infusions. Sixty three AS patients were given three infusions of 5 mg/kg of infliximab at weeks 0, 2, and 6 and evaluated serially before each infusion and also at week 10. Afterwards, patients were followed up by telephone interview until their disease activities were >60% of the baseline values. At that point, disease was considered to have relapsed. Clinical parameters at baseline as well as at week 2 were used for analysis to identify factors that might predict an improvement at week 10, or predict a delayed relapse. A predictor is regarded as being useful if the area under the curve (AUC) when analyzed by receiver operator calculations (ROC) exceeds 0.75. No parameters at baseline have sufficient predictive values. However, ASAS20 (Assessment in Ankylosing Spondylitis International Working Group criteria) at week 2 predicts improvement at week 10, and also duration of clinical response after discontinuing the infliximab at week 6. The response to one pulse of infliximab is the best predictor of subsequent response as well as rate of relapse after discontinuing the infliximab.

Evolutive pattern in Crohn's disease: a simplified index using clinical parameters predicts obstructive behaviour.

Two clearly differentiated evolutive patterns of Crohn's disease, obstructive and fistulizing, exist, but the early clinical parameters which can predict the evolution are unknown. To evaluate whether clinical variables, present at the time of diagnosis, may help in predicting a subsequent evolutive behaviour. Ninety out of 140 evaluable patients were included. After a median of 50.2 months since diagnosis, 64 patients (71%) followed an obstructive pattern while 26 patients (28.9%) had a fistulizing form. Clinical variables were analysed as predictors of outcome. Logistic regression was carried out in order to obtain a mathematical model that would predict the evolution. The individual ability of the mathematical model to predict evolution was assessed using relative receiver operating characteristic (ROC) curves. The variables which were retained in the model were duration of disease before diagnosis (DD), onset of symptoms (OS), presence of anal disease (AD) and the presence of abdominal mass (AM). The equation z = -9.49 + 2.2643 (AD) - 0.0066 (DD) + 2.5282 (AM) + 1.3433 (OS) was obtained. The probability of evolution towards an obstructive form was P = 1/(1 + e(-Z)). This model can predict 96.88% of obstructive forms but only 53.85% of fistulizing forms. The mathematical point section (ROC curve) corresponds to a probability of 45.2%. Considering an obstructive pattern when the probabilities are above this point, the sensitivity is 98% and the specificity is 50%. The prediction of an obstructive pattern is feasible using simple clinical variables. The mathematical model obtained is useful for predicting this but not the fistulizing pattern.

Capillary leak syndrome in children who undergo cardiopulmonary bypass: clinical outcome in comparison with complement activation and C1 inhibitor.

Capillary leak syndrome (CLS) is associated with significantly increased morbidity and occurs after cardiopulmonary bypass in children with congenital heart disease. We investigated the early clinical parameters that predict the development of CLS and examined the relationship between the presence of CLS and complement and contact activation and C1 esterase inhibitor (C1-INH) during and after bypass. In this prospective study we took serial serological measurements of the complement and contact system and C1-INH in a cohort of 27 infants before, during, and up to 96 h after open-heart surgery. Complement and contact activation and a decrease in C1-INH were measured in all infants during and after CPB. Ten infants developed CLS postoperatively. Younger age and longer bypass time were strongly correlated to the development of CLS. No relationship was found between the degree of hypothermia, weight, gender, or cross-clamp time. C1-INH concentration and activity were lower peri- and postoperatively in the CLS group. Infants with CLS had a more pronounced postoperative increase in the C5a and C3a levels, higher postoperative level of factor XIIa, and lower prekallikrein activity than those without CLS. Contact and complement activation occurs during cardiopulmonary bypass and contributes to CLS more frequently in infants of a younger age and with a prolonged bypass time. This activation and decrease in C1-INH was strongly expressed in the CLS group, and therefore early substitution of C1-INH may prevent CLS after open-heart surgery in high-risk infants.