scholarly journals Investigation into the reproducibility of the association of cord blood magnesium concentration and cerebral palsy or death in children

2020 ◽  
Author(s):  
Christopher Luke Dixon ◽  
Xiaoxi Liu ◽  
Alfred Balch ◽  
Maged Costantine ◽  
Catherine M. Sherwin
Keyword(s):  
Cerebral Palsy ◽  
Cord Blood ◽  
Magnesium Sulfate ◽  
Neonatal Death ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Magnesium Concentration ◽  
Secondary Outcome ◽  
Ultrasound Findings

Abstract Objective: To evaluate the association of cord blood magnesium concentrations at the time of birth with cerebral palsy (CP) and neonatal death. Study Design: A secondary analysis of a randomized controlled trial that randomized women at imminent risk of delivery between 24 and 31 weeks of gestation to receive magnesium sulfate or placebo. This ‘study’s primary outcome was a composite of either moderate to severe CP or death. Secondary outcomes included CP, moderate to severe CP, neonatal death, and neonatal head ultrasound findings. We used a logistic regression model to evaluate the relationship between the concentration of magnesium in cord blood and study outcomes. Results: A total of 668 women were included in this analysis and were randomized to magnesium sulfate at 28 ± 2.5 ‘weeks’ gestation. Cord blood magnesium concentrations were not associated with the primary outcome of infant death by 1 year of age or moderate or severe cerebral palsy, as assessed at or beyond 2 years of age (aOR 0.95 (0.67, 1.36), p = 0.79). Cord blood magnesium concentrations were not associated with any of the secondary outcome measurements. Conclusion: Cord blood magnesium concentrations were not associated with moderate to severe cerebral palsy or death, or other neurodevelopmental or sonographic outcomes.

scholarly journals Cord Blood Haptoglobin, Cerebral Palsy and Death in Infants of Women at Risk for Preterm Birth: A Secondary Analysis of a Randomised Controlled Trial

2019 ◽  
Vol 9 ◽  
pp. 11-18 ◽  
Author(s):  
Catalin S. Buhimschi ◽  
Kathleen A. Jablonski ◽  
Dwight J. Rouse ◽  
Michael W. Varner ◽  
Uma M. Reddy ◽  
...  
Keyword(s):  
At Risk ◽  
Cerebral Palsy ◽  
Preterm Birth ◽  
Randomised Controlled Trial ◽  
Cord Blood ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Randomised Controlled

Prenatal Tobacco Exposure and Childhood Neurodevelopment among Infants Born Prematurely

2020 ◽  
Author(s):  
Lindsay S. Robbins ◽  
Christina T. Blanchard ◽  
Rachel G. Sinkey ◽  
Stacy L. Harris ◽  
Alan T. Tita ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Tobacco Use ◽  
Infant Development ◽  
Illicit Drugs ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Tobacco Exposure ◽  
Adjusted Analysis ◽  
Multicenter Randomized Controlled Trial

Objective Nicotine is an established neuroteratogen, and prenatal tobacco exposure alters the structure of the developing nervous system. An association between prenatal tobacco exposure and impaired neurologic function is less well established. We examine the association between prenatal tobacco exposure and childhood neurodevelopment among infants born preterm. Study Design Secondary analysis of a multicenter randomized controlled trial assessing the benefits of magnesium sulfate for the prevention of cerebral palsy in preterm infants. Women were included if they delivered a singleton and nonanomalous infant before 37 weeks. Exposure was any self-reported prenatal tobacco use. Primary outcome was the original trial composite outcome of moderate or severe cerebral palsy at 2 years of age, or stillbirth, or infant death by 1 year of age. Secondary outcomes included components of the composite and mild cerebral palsy at 2 years, Bayley Scales of Infant Development II motor and mental scores, death before two years, and use of auditory aids or corrective lenses. Multivariable logistic regression models were performed to estimate adjusted odds ratios (aOR) with 95% confidence intervals. Results Of 1,826 women included, 503 (27.5%) used tobacco. Tobacco users were more likely to be older, unmarried, and white; have a prior preterm birth; have received no prenatal care; and to use illicit drugs or alcohol. Gestational age at delivery, betamethasone exposure, and magnesium exposure were not different between groups. There were no differences in the composite primary outcome or in rates of cerebral palsy by tobacco use. Moderate developmental delay was more common among tobacco exposed in bivariate but not adjusted analysis (20.5 vs. 15.9%, p = 0.035). In adjusted analysis, tobacco exposure was associated with increased use of corrective lenses (5.0 vs. 2.9%, aOR: 2.28, 95% confidence interval: 1.28–4.07). Conclusion Prenatal tobacco exposure is not associated with neurodevelopmental impairment in infants born preterm. However, tobacco exposure may be associated with impaired vision. Key Points

scholarly journals Association between antenatal ultrasound findings and neonatal outcomes in rural Uganda: a secondary analysis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Delia Horn ◽  
Erika Edwards ◽  
Renny Ssembatya ◽  
Kristen DeStigter ◽  
Anne Dougherty ◽  
...  
Keyword(s):  
Amniotic Fluid ◽  
Neonatal Death ◽  
Secondary Analysis ◽  
Outcome Data ◽  
Fluid Volume ◽  
Delivery Room ◽  
Secondary Outcome ◽  
Multiple Gestation ◽  
Amniotic Fluid Volume ◽  
Ultrasound Findings

Abstract Background Although the use of prenatal ultrasound services has increased in low- income and lower middle-income countries, there has not been a concurrent improvement in perinatal mortality. It remains unknown whether individual ultrasound findings in this setting are associated with neonatal death or the need for resuscitation at delivery. If associations are identified by ultrasound, they could be used to inform the birth attendant and counsel the family regarding risk, potentially altering delivery preparedness in order to reduce neonatal mortality. Methods This was a secondary analysis of data collected from a prospective cohort. Data was gathered at Nawanyago Health Centre III in Kamuli District, Uganda. Participants included pregnant women who received second and third trimester prenatal ultrasound scans and delivered at that center between July 2010 and August 2018. All ultrasounds were performed at Nawanyago and deliveries were attended solely by midwives or nurses. Predictor variables included the following ultrasound findings: fetal number, fetal presentation, and amniotic fluid volume. The primary outcome was bag-mask ventilation (BMV) of the neonate at delivery. The secondary outcome was stillbirth or neonatal death in the delivery room. Results Primary outcome data was available for 1105 infants and secondary outcome data was available for 1098 infants. A total of 33 infants received BMV at delivery. The odds of receiving BMV at delivery was significantly increased if amniotic fluid volume was abnormal (OR 4.2, CI 1.2-14.9) and there were increased odds for multiple gestation (OR 1.9, CI 0.7-5.4) and for non-vertex fetal presentation (OR 1.4, CI 0.6-3.2) that were not statistically significant. Stillbirth or neonatal death in the delivery room was diagnosed for 20 infants. Multiple gestation (OR 4.7, CI 1.6-14.2) and abnormal amniotic fluid volume (OR 4.8, CI 1.0-22.1) increased the odds of stillbirth or neonatal death in the delivery room, though only multiple gestation was statistically significant. Conclusion Common findings that are easily identifiable on ultrasound in low- and lower middle-income countries are associated with adverse perinatal outcomes. Education could lead to improved delivery preparedness, with the potential to reduce perinatal mortality. This was a preliminary study; larger prospective studies are needed to confirm these findings.

scholarly journals Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Plasma Therapy

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.

Fascial treatment versus manual therapy (HVLA) in patients with chronic neck pain: A randomized controlled trial

2021 ◽  
pp. 1-10
Author(s):  
Katrin Brück ◽  
Kirsten Jacobi ◽  
Tobias Schmidt
Keyword(s):  
Neck Pain ◽  
Manual Therapy ◽  
Repeated Measures ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severity Of Illness ◽  
Chronic Neck Pain ◽  
Secondary Outcome ◽  
Control Group ◽  
Industrialized Nations

BACKGROUND: Chronic neck pain (CNP) is a common health problem in western industrialized nations. In recent years, the fascial tissue has attracted the attention of therapists, and a treatment of the fasciae promises to be a meaningful approach in the therapy of patients with CNP. OBJECTIVE: The aim of this study was to investigate the effectiveness of a fascial treatment (FT) compared to manual therapy (MT) and to no intervention (control group, CG) in patients with CNP. METHODS: Sixty participants with CNP were randomized into three groups. Primary outcome parameters were pain intensity as measured by the visual analogue scale (VAS), and severity of illness as measured by the Neck Pain and Disability Scale (NPAD). Secondary outcome parameter was the range of motion (ROM) of the cervical spine. RESULTS: Repeated measures t-tests demonstrated significant decreases with medium to large effect sizes for the FT (VAS: dR⁢M= 1.14; NPAD: dR⁢M= 0.51) and for the MT (VAS: dR⁢M= 1.15; NPAD: dR⁢M= 0.72). CONCLUSION: Our results confirmed the effectiveness of MT on pain and severity of illness in the treatment of patients suffering from CNP. Furthermore, the results demonstrated the effectiveness and clinical relevance of FT for this population.

scholarly journals A Randomized, Controlled Trial of Magnesium Sulfate for the Prevention of Cerebral Palsy

2008 ◽  
Vol 359 (9) ◽  
pp. 895-905 ◽  
Author(s):  
Dwight J. Rouse ◽  
Deborah G. Hirtz ◽  
Elizabeth Thom ◽  
Michael W. Varner ◽  
Catherine Y. Spong ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cerebral Palsy ◽  
Magnesium Sulfate ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Association between Age, Weight, and Dose and Clinical Response to Probiotics in Children with Acute Gastroenteritis

2020 ◽  
Vol 151 (1) ◽  
pp. 65-72
Author(s):  
David Schnadower ◽  
Robert E Sapien ◽  
T Charles Casper ◽  
Cheryl Vance ◽  
Phillip I Tarr ◽  
...  
Keyword(s):  
Acute Gastroenteritis ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Interaction Effects ◽  
Secondary Outcome ◽  
Z Score ◽  
Double Blind ◽  
Multicenter Randomized Controlled Trial ◽  
Weight Percentile ◽  
Age And Sex

ABSTRACT Background Gastroenteritis is a common and impactful disease in childhood. Probiotics are often used to treat acute gastroenteritis (AGE); however, in a large multicenter randomized controlled trial (RCT) in 971 children, Lactobacillus rhamnosus GG (LGG) was no better than placebo in improving patient outcomes. Objectives We sought to determine whether the effect of LGG is associated with age, weight z score and weight percentile adjusted for age and sex, or dose per kilogram administered. Methods This was a preplanned secondary analysis of a multicenter double-blind RCT of LGG 1 × 1010 CFU twice daily for 5 d or placebo in children 3–48 mo of age with AGE. Our primary outcome was moderate to severe gastroenteritis. Secondary outcomes included diarrhea and vomiting frequency and duration, chronic diarrhea, and side effects. We used multivariable linear and nonlinear models testing for interaction effects to assess outcomes by age, weight z score and weight percentile adjusted for age and sex, and dose per kilogram of LGG received. Results A total of 813 children (84%) were included in the analysis; 413 received placebo and 400 LGG. Baseline characteristics were similar between treatment groups. There were no differential interaction effects across ranges of age (P-interaction = 0.32), adjusted weight z score (P-interaction = 0.43), adjusted weight percentile (P-interaction = 0.45), or dose per kilogram of LGG received (P-interaction = 0.28) for the primary outcome. Whereas we found a statistical association favoring placebo at the extremes of adjusted weight z scores for the number of vomiting episodes (P-interaction = 0.02) and vomiting duration (P-interaction = 0.0475), there were no statistically significant differences in other secondary outcome measures (all P-interactions &gt; 0.05). Conclusions LGG does not improve outcomes in children with AGE regardless of the age, adjusted weight z score, and adjusted weight percentile of participants, or the probiotic dose per kilogram received. These results further strengthen the conclusions of low risk of bias clinical trials which demonstrate that LGG provides no clinical benefit in children with AGE. This trial was registered at clinicaltrials.gov as NCT01773967.

Abstract 133: White Matter Hyperintensity and Cardiovascular Disease Outcomes: A Secondary Analysis of the SPRINT MIND Trial

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Adam H de Havenon ◽  
Tanya Turan ◽  
Sharon Yeatts ◽  
Rebecca Gottesman ◽  
Shyam Prabhakaran ◽  
...  
Keyword(s):  
White Matter ◽  
Primary Outcome ◽  
Stroke Risk ◽  
Secondary Analysis ◽  
White Matter Hyperintensity ◽  
Secondary Outcome ◽  
Cox Models ◽  
Disease Outcomes ◽  
Hazard Ratios ◽  
The Mean

Background: The Systolic Blood Pressure Intervention Trial (SPRINT) randomized patients to a goal SBP <120 mm Hg vs. <140 mm Hg . A subset of patients enrolled in SPRINT MIND, which performed a baseline MRI and measured white matter hyperintensity volume (WMHv). We evaluated the association between WMHv and cardiovascular events. Methods: The primary outcome was a composite of stroke, MI, ACS, decompensated CHF, or CVD death. The secondary outcome was stroke. The WMHv was divided into quartiles. We fit Cox models to the outcomes and report adjusted hazard ratios for the quartiles of WMHv, and stratified by SPRINT treatment arm. Results: Among 719 included patients, the mean WMHv in the quartiles was 0.34, 1.09, 2.61, and 10.8 mL. The primary outcome occurred in 51/719 (7.1%) and the secondary outcome in 10/719 (1.4%). The WMHv was associated with both outcomes (Table 1, Figure 1). After stratifying by treatment arm, we found the association persisted in the standard, but not intensive, treatment arm (Table 2). However, the interaction term between WMHv and treatment arm was not significant. Conclusions: We observed that degree of WMH was associated with CVD and stroke risk in SPRINT MIND. The risk may be attenuated in patients randomized to intensive BP lowering. Trials are needed to determine if intensive BP lowering can prospectively reduce the high cardiovascular risk in patients with WMH.

Sign in / Sign up

Export Citation Format

Share Document