Academic literature on the topic 'Newborn infants Effect of drugs on Case studies'

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Journal articles on the topic "Newborn infants Effect of drugs on Case studies"

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Pansari, A., K. Abduljalil, and T. Johnson. "O07 Predictive performance of a physiologically based pharmacokinetic model of caffeine in the preterm population." Archives of Disease in Childhood 104, no. 6 (May 17, 2019): e3.2-e3. http://dx.doi.org/10.1136/archdischild-2019-esdppp.7.

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BackgroundCaffeine has been extensively used in the treatment of apnoea in premature infants,1 its disposition varies with postnatal age2 and can differ markedly between premature and term neonates.MethodsThe Preterm population within the Simcyp Simulator V18R1 population library was used to replicate clinical studies to predict caffeine exposure after single3 and multiple4 intravenous administration to preterm neonates of gestational weeks 28.5 and 29 (28–33) respectively, ranging in postnatal age of 3–30 days and 0–3 days respectively. Predictive performance of the Physiologically Based Pharmacokinetic Model (PBPK) was evaluated by comparing the simulated to the clinical results. A population simulation was performed for the single dose study as only pharmacokinetic parameters were available. However, for multiple doses study, where individual plasma concentration-time profile data were available, simulations were performed for each individual.ResultsPBPK model predictions for caffeine in preterm neonates were in good agreement with the clinical observations. In the case of single dose administration, the ratios of predicted vs observed mean Volume of distribution (Vss), peak plasma concentration (Cmax), Clearance (CL) and Half-life (t1/2) were 1, 1.2, 1 and 1.1, respectively. Individual predicted concentration-time profiles following multiple dose administration were in close agreement with the observed data for all 16 subjects, overall 95% of individual observed data points were within the 5th and 95th percentile of predicted plasma concentration-time profile.ConclusionsThe predictive performance of preterm PBPK models for caffeine was found to be appropriate. A similar PBPK approach can be utilized in the clinics for the accurate prediction of pharmacokinetic parameters and plasma concentrations and for dosage adjustment to attain specific plasma concentrations of drugs in premature population.ReferencesGiacoia, et al. Effects of formula feeding on oral absorption of caffeine in premature infants. Dev Pharmacol Ther 1989; 12:205–210.Johnson, et al. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clin Pharmacokinet 2006; 45(9):931–56.Aranda, et al. Population Pharmacokinetic profile of caffeine in the premature newborn infant with apnea; The Journal of Pediatrics 1979; 94(4.):663–668.Lee, et al. Caffeine in apnoeic asian neonates: a sparse data analysis. Br J Clin Pharmacol 2002; 54:31–37.Disclosure(s)Nothing to disclose
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Ng, Eugene, Gil Klinger, Vibhuti Shah, and Anna Taddio. "Safety of Benzodiazepines in Newborns." Annals of Pharmacotherapy 36, no. 7-8 (July 2002): 1150–55. http://dx.doi.org/10.1345/aph.1a328.

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BACKGROUND: Benzodiazepines are being used in neonatal intensive care units for sedation and control of seizures. However, anecdotal reports suggest that their use in infants may be associated with serious adverse effects (AEs). OBJECTIVE: To determine the incidence of AEs from benzodiazepine use in preterm and full-term infants. METHODS: Retrospective chart review of 63 infants who received benzodiazepines as a sedative or anticonvulsant over a 16-month period. RESULTS: Mean ± SD gestational age of the infants was 33.1 ± 6.2 weeks, and birth weight was 2.3 ± 1.2 kg. Median (range) postnatal age at commencement of drug administration was 19 (5–54) days. Forty-one infants received lorazepam, 8 received midazolam, and 14 received both. Ten (16%) of the infants had 14 documented adverse events: seizures (n = 6), hypotension (n = 5), and respiratory depression (n = 3). Using a validated adverse drug reaction probability scale, a probable association with benzodiazepine use was demonstrated in 12 of the AEs. Due to the retrospective nature of the data, a score for definite association was not attainable. Anticonvulsant administration was required for 4 of 6 infants and, in all cases of respiratory depression, ventilatory support was initiated or increased. Two cases of significant hypotension were treated with inotropes. There was no statistically significant correlation between AEs and benzodiazepine dose or concomitant use of inotropes or analgesics (morphine), although most infants had underlying medical conditions or received multiple drugs that may have predisposed them to experience AEs. CONCLUSIONS: Administration of benzodiazepines was frequently associated with AEs in full-term and preterm infants. It is possible that underlying illnesses and concomitant drug use predisposed these effects. Until the benefit-to-risk ratio is determined by further studies, judicious use of benzodiazepines is recommended in this vulnerable population.
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Sininger, Yvonne S., Carmen G. Condon, Howard J. Hoffman, Amy J. Elliott, Hein J. Odendaal, Larry L. Burd, Michael M. Myers, and William P. Fifer. "Transient Otoacoustic Emissions and Auditory Brainstem Responses in Low-Risk Cohort of Newborn and One-Month-Old Infants: Assessment of Infant Auditory System Physiology in the Prenatal Alcohol in SIDS and Stillbirth Network Safe Passage Study." Journal of the American Academy of Audiology 29, no. 08 (September 2018): 748–63. http://dx.doi.org/10.3766/jaaa.17043.

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AbstractThe Prenatal Alcohol and Sudden Infant Death Syndrome and Stillbirth Network, known as the “Safe Passage Study,” enrolled approximately 12,000 pregnant women from the United States and South Africa and followed the development of their babies through pregnancy and the infant’s first year of life to investigate the role of prenatal alcohol exposure in the risk for sudden infant death syndrome (SIDS) and adverse pregnancy outcomes, such as stillbirth and fetal alcohol spectrum disorders.Auditory system tests were included in the physiologic test battery used to study the effects of prenatal alcohol exposure on neurophysiology and neurodevelopment, as well as potential causal relationships between neurodevelopmental disorders and SIDS and/or stillbirth. The purpose of this manuscript is to describe normative results when using the auditory test battery applied.The test battery included the auditory brainstem response (ABR) and transient-evoked otoacoustic emissions (TEOAEs). Data were collected on individual ears of newborns and 1-month-old infants.From a cohort of 6,070 with auditory system exams, a normative subsample of 325 infants were selected who were not exposed prenatally to alcohol, cigarette smoke, or drugs nor were they preterm or low birthweight. The subsample is small relative to the overall study because of strict criteria for no exposure to substances known to be associated with SIDS or stillbirth and the exclusion of preterm and low birthweight infants. Expectant mothers were recruited from general maternity at two comprehensive clinical sites, in the northern plains in the United States and in Cape Town, South Africa. These populations were selected for study because both were known to be at high-risk for SIDS and stillbirth.ABR and TEOAE recordings were stored electronically. Peak latency and amplitude analysis of ABRs were determined by study personnel, and results were evaluated for differences by age, sex, test site, race, and ear (left versus right).TEOAE findings were consistent with existing literature including the increase in signal-to-noise (SNR) over the first month of life. The SNR increase is due to an increase in amplitude of the emission. TEOAE amplitude asymmetry favoring the right ear was found, whereas SNR asymmetry was not, perhaps because of the small sample size. A nonsignificant trend toward larger responses in female babies was found; a result that is generally statistically significant in studies with larger samples. Latencies were found to be shorter in ABRs elicited in the right ear with amplitudes that were slightly bigger on average. An expected decrease in wave V latency was observed from birth to 1-month of age, but the finding was of borderline significance (p = 0.058).One month is a short time to judge development of the auditory system; however, the ABR and TEOAE findings were consistent with current literature. We conclude that the auditory system data acquired for the Safe Passage Study, as reflected in the data obtained from this cohort of “unexposed” infants, is consistent with published reports of these auditory system measures in the general population.
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Roland, Hannah, Amanda Brown, Amy Rousselot, Natalie Freeman, J. Michael Wieting, Stephen Bergman, and Debasis Mondal. "Osteopathic Manipulative Treatment Decreases Hospital Stay and Healthcare Cost in the Neonatal Intensive Care Unit." Medicines 9, no. 10 (September 21, 2022): 49. http://dx.doi.org/10.3390/medicines9100049.

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Osteopathic manipulative treatment (OMT) is used in both inpatient and outpatient settings. Evidence suggests that OMT can reduce both patients’ recovery time and the financial cost of their acute medical treatment and rehabilitation. Multiple studies from neonatal intensive care units (NICUs) are presented in this article that demonstrate infants treated with OMT recover faster, are discharged earlier, and have lower healthcare costs than their non-OMT-treated counterparts. Data clearly show that adjunctive OMT facilitates feeding coordination in newborns, such as latching, suckling, swallowing, and breathing, and increases long-term weight gain and maintenance, which reduces hospital length of stay (LOS). Osteopathic techniques, such as soft tissue manipulation, balanced ligamentous tension, myofascial release, and osteopathic cranial manipulation (OCM), can reduce regurgitation, vomiting, milky bilious, or bloody discharge and decrease the need for constipation treatment. OMT can also be effective in reducing the complications of pneumonia in premature babies. Studies show the use of OCM and lymphatic pump technique (LPT) reduces the occurrence of both aspiration and environmentally acquired pneumonia, resulting in significantly lower morbidity and mortality in infants. Based on published findings, it is determined that OMT is clinically effective, cost efficient, a less invasive alternative to surgery, and a less toxic choice to pharmacologic drugs. Therefore, routine incorporation of OMT in the NICU can be of great benefit in infants with multiple disorders. Future OMT research should aim to initiate clinical trial designs that include randomized controlled trials with larger cohorts of infants admitted to the NICU. Furthermore, a streamlined and concerted effort to elucidate the underlying molecular mechanisms associated with the beneficial effects of OMT will aid in understanding the significant value of incorporating OMT into optimal patient care.
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Likholetova, N. V., A. M. Anuryev, S. M. Gorbacheva, T. I. Pavlova, and A. B. Pavlov. "THE EFFECT OF HYPOXIC BRAIN DAMAGE ON THE SURVIVAL OF PREMATURE INFANTS." Acta Biomedica Scientifica 3, no. 5 (October 29, 2018): 76–81. http://dx.doi.org/10.29413/abs.2018-3.5.12.

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The central nervous system injuries are a common neonatal pathology, hypoxia being one of the main causes of cerebral dysfunction. The purpose of this study was studying the incidence of hypoxic cerebral disorders in premature infants with an extremely low body weight and a very low birth weight and revealing the risk factors that adversely affected the disease outcome. The subject of the study was preterm infants whose gestational age did not exceed 31 weeks. The main criterion for inclusion into the study was the presence of hypoxic-ischemic and hypoxic-hemorrhagic brain damage. To reveal the perinatal risk factors, the somatic health of mothers, and pregnancy and childbirth peculiarities were studied. The structure of children’s pathology and intensive care techniques were analyzed. Cerebral disorders were verified in 42 out of 176 patients (23.5 %). 2–3rd-degree intraventricular hemorrhage was diagnosed in 34 newborns (80.9 %), severe ischemia in 8 children (19.1 %). To determine the structure of the disease outcome, all children were divided into deceased and survivors. A fatal outcome was observed in 14 cases (33.3 %). The mothers of deceased children were more likely to have obstetric and concomitant extragenital pathologies. Analysis of pediatric pathology showed that the hemodynamically significant functioning arterial duct and severe asphyxia in childbirth were much more frequent in deceased children. Intensive therapy of deceased children included «hard» parameters of artificial ventilation and high doses of cardiotonic drugs. Thus the presented risk factors can be considered as predictors of an unfavorable outcome in children with this pathology.
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Srivastava, Ankur, Amuchou Soraisham, Prashanth Murthy, Sharandeep Kaur, Majeeda Kamaluddeen, Sumesh Thomas, Amelie Stritzke, Essa Al-Awad, and Khorshid Mohammad. "7 Efficacy of Pharmacologic Therapy for Patent Ductus Arteriosus Closure in Preterm Newborns According to Their Gestational Age-Specific Z-Score for Birth Weight." Paediatrics & Child Health 26, Supplement_1 (October 1, 2021): e4-e5. http://dx.doi.org/10.1093/pch/pxab061.003.

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Abstract Primary Subject area Neonatal-Perinatal Medicine Background Preterm infants who are also intrauterine growth restricted (IUGR) experience more frequent and earlier hemodynamic consequences of patent ductus arteriosus (PDA). This may be related to altered levels of prostaglandins or altered number or sensitivity of their receptors in IGUR infants. Few studies have examined the efficacy of pharmacologic therapy (non-steroidal anti-inflammatory drugs [NSAIDs]: indomethacin, ibuprofen, or acetaminophen) for PDA closure among preterm infants based on their degree of IUGR with differing results. Objectives Primary: To determine if the degree of IUGR [defined by birth weight (BW) z-score] affects the efficacy of pharmacologic PDA closure and rate of surgical PDA ligation in preterm infants. Secondary: To compare the side effects of NSAIDs and neonatal outcomes based on the severity of IUGR. Design/Methods This retrospective cohort study included infants of < 30 weeks’ GA, admitted to a tertiary neonatal intensive care unit (NICU) between 2010 and 2018, with hemodynamically significant PDA and treated with NSAIDs. Infants with major congenital anomalies, those who received prophylactic Indomethacin and those who died in the first 48 hours were excluded. Birth weight (BW) z-scores were calculated using Olsen nomograms and classified into 3 categories: z-score > −0.5 (normal), z-score −0.5 to −2.0 (mild to moderate growth restriction), z-score <−2 (severe IUGR). We compared responses to NSAID treatment and PDA ligation. Multivariate logistic regression analysis was done to examine the association of BW z-score and response to pharmacological therapy and subsequent surgical PDA ligation. Results Of the 1511 eligible infants, 769 (51%) had a diagnosis of PDA. Of 517 included infants, 323 (62.5%) had BW z-score >− 0.5, while 154 (29.8%) had z-scores − 0.5 to −2.0 and 40 (7.7%) had z-score < −2. Table 1 shows their demographic characteristics. Efficacy of first course of NSAIDs was not different among these birth weight groups (Table 2). There was no difference in the side effects and neonatal morbidities amongst the three groups (Table 2). Multivariate logistic regression analysis after controlling for GA, gender, antenatal steroids, C-section, and SNAP II showed that the odds of PDA ligation was significantly higher among infants with BW z-score < −2 (aOR 2.68, 95% CI 1.13- 6.36) but not among infants with z-score −0.5 to−2.0 (aOR 1.41, 95% CI 0.84, 2.39) as compared to z-score >-0.5. Conclusion Preterm severe IUGR infants with z-score < −2 have an associated increased risk of PDA ligation following pharmacologic treatment as compared to normally grown infants.
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Podolská, K., D. Mazánková, and M. Göböová. "Retrospective Assessment of the Use of Pharmacotherapeutic Agents in Pregnancy with Potential Impact on Neonatal Health." European Pharmaceutical Journal 69, no. 2 (August 1, 2022): 17–25. http://dx.doi.org/10.2478/afpuc-2022-0015.

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Abstract This study focuses on the role of a clinical pharmacist in the optimisation of pharmacotherapy in the case of patients during pregnancy and its importance within the hospital sector in Slovakia. Retrospective evaluation of pharmacotherapy in pregnant patients with a focus on teratogenicity and appropriate drug selection was used. The hospital data were collected during 24 months from 22 female patients. The main observed outcome was health condition of the newborn, and it was expressed as healthy newborn, illness of the newborn, any congenital defect or malformation, spontaneous abortion, or unspecified information about the newborn. Based on a foetal risk assessment of used therapeutic agents from the Summary of Product Characteristics (SmPC), basal foetal and neonatal risk assessment (Briggs et al., 2017), and recommendations and related human past reports and supporting evidence studies, drugs were divided into two groups: confirmed foetal risk drugs and negative (nonconfirmed) foetal risk drugs. A total of 36.3% of the patients used two drugs. Patients most frequently used drugs during the first trimester (81.8%). During pregnancy, the most used drugs were for the nervous system (25.5%), anti-infective agents (23.6%), and respiratory therapeutic agents (14.5%). Of the 22 patients, 16 (73%) had healthy newborns, despite the use of therapeutic agents with different foetal-risk variations. In the group of therapeutic agents with confirmed risk, in some, negative effect on the newborn's health was clinically manifested. Spontaneous abortion was present after using norethisterone acetate and valproic acid; birth defect (unspecified) was present after usage of interferon β-1a and methylprednisolone sodium succinate. An illness (heart murmur) was present after the use of monohydrate sodium salt of metamizole. Another illness (Wilm's tumour) was present after the use of budesonide. Unspecified information about the newborn was observed in four cases after the use of prednisone, allopurinol, nadroparin, and fluvastatin.
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Starodubtseva, Natalia, Svetlana Kindysheva, Alyona Potapova, Evgenii Kukaev, Zulfiya Khodzhaeva, Ekaterina Bockeria, Vitaliy Chagovets, Vladimir Frankevich, and Gennady Sukhikh. "Transplacental Therapeutic Drug Monitoring in Pregnant Women with Fetal Tachyarrhythmia Using HPLC-MS/MS." International Journal of Molecular Sciences 24, no. 3 (January 17, 2023): 1848. http://dx.doi.org/10.3390/ijms24031848.

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Fetal arrhythmia develops in 0.1–5% of pregnancies and may cause fetal heart failure and fetal hydrops, thus increasing fetal, neonatal, and infant mortality. The timely initiation of transplacental antiarrhythmic therapy (ART) promotes the conversion of fetal tachycardia to sinus rhythm and the regression of the concomitant non-immune fetal hydrops. The optimal treatment regimen search for the fetus with tachyarrhythmia is still of high value. Polymorphisms of these genes determines the individual features of the drug pharmacokinetics. The aim of this study was to study the pharmacokinetics of transplacental anti-arrhythmic drugs in the fetal therapy of arrhythmias using HPLC-MS/MS, as well as to assess the effect of the multidrug-resistance gene ABCB1 3435C > T polymorphism on the efficacy and maternal/fetal complications of digoxin treatment. The predisposition to a decrease in the bioavailability of the digoxin in patients with a homozygous variant of the CC polymorphism showed a probable association with the development of ART side effects. A pronounced decrease in heart rate in women with the 3435TT allele of the ABCB1 gene was found. The homozygous TT variant in the fetus showed a probable association with an earlier response to ART and rhythm disruptions on the digoxin dosage reduction. high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) methods for digoxin and sotalol therapeutic drug monitoring in blood plasma, amniotic fluid, and urine were developed. The digoxin and sotalol concentrations were determined in the plasma blood, urine, and amniotic fluid of 30 pregnant women at four time points (from the beginning of the transplacental antiarrhythmic therapy to delivery) and the plasma cord blood of 30 newborns. A high degree of correlation between the level of digoxin and sotalol in maternal and cord blood was found. The ratio of digoxin and sotalol in cord blood to maternal blood was 0.35 (0.27 and 0.46) and 1.0 (0.97 and 1.07), accordingly. The digoxin concentration in the blood of the fetus at the moment of the first rhythm recovery episode, 0.58 (0.46, 0.8) ng/mL, was below the therapeutic interval. This confirms the almost complete transplacental transfer of sotalol and the significant limitation in the case of digoxin. Previously, ABCB1/P-glycoprotein had been shown to limit fetal exposure to drugs. Further studies (including multicenter ones) to clarify the genetic features of the transplacental pharmacokinetics of antiarrhythmic drugs are needed.
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Czeizel, Andrew, István Dudás, János Gidai, and Erzsébet Horváth-Puhó. "No effect of human chorionic gonadotropin treatment due to threatened abortion in early pregnancy for birth outcomes." Open Medicine 3, no. 1 (March 1, 2008): 71–76. http://dx.doi.org/10.2478/s11536-007-0056-9.

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AbstractHuman chorionic gonadotropin (HCG) is used parenterally for treatment of threatened abortions and repeated spontaneous abortion in pregnant women. No controlled epidemiological studies of preterm birth and low birthweight newborns in pregnant women with HCG treatment have been published while the results of animal investigations were controversial. The data of 97 pregnant women with HCG treatment in the second and third months of pregnancy due to threatened abortion and/or previous spontaneous abortion(s) was compared with the data of other 38,054 pregnant women in the population-based large data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities. There was no difference in mean gestational age at delivery and birth weight, in addition the rate of preterm birth and low birthweight newborns. Parenteral HCG treatment in the early pregnancy due to threatened abortion did not associate with a higher risk for preterm births or low birthweight newborns. However, a higher occurrence of gestational diabetes was found in pregnant women with HCG treatment and there was a slight male excess among newborn infants (p=0.06).
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Phibbs, Ciaran S., and Lynn Mortensen. "Back Transporting Infants From Neonatal Intensive Care Units to Community Hospitals for Recovery Care: Effect on Total Hospital Charges." Pediatrics 90, no. 1 (July 1, 1992): 22–26. http://dx.doi.org/10.1542/peds.90.1.22.

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Many neonates are referred to neonatal intensive care units (NICUs) for specialized care far from their parents' residence. This distance can add to the stress of the parents and reduce the contact of the parents with their newborn. Small studies have found that back transporting these neonates to hospitals closer to their homes is safe and cost-effective. Despite these findings, the reluctance of many insurers to pay for back transports prevents or delays many back transports. Insurers may not consider the findings of the previous studies to be conclusive, given that the comparisons were between small numbers of neonates back transported and neonates who remained in tertiary care, and the potential for differences in severity of illness between the groups is significant. In this study the effect on hospital charges of back transports was examined by comparing the charges for care in community hospitals with what these charges would have been in a tertiary care center. The advantage of this method is that it avoids case-mix differences between the groups and thus minimizes the potential for small-sample bias. Data were collected for all back transports from a NICU to non-tertiary care centers (n = 90) for a 9-month period. We were able to obtain the itemized bills for the care at community hospitals for 42 of these patients. Each bill was recalculated using the charges for the NICU to determine potential for savings. The average charges for recovery care were about $6200 lower at the community hospital than they would have been at the NICU. When the charges for the back transport are subtracted (mean = $1603), the average net savings are $4,600. These savings are even larger ($6163) for neonates who stayed at the community hospital for more than 7 days.
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Books on the topic "Newborn infants Effect of drugs on Case studies"

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Lee, Wetherington Cora, Smeriglio Vincent L, Finnegan Loretta P, National Institutes of Health (U.S.), and National Institute on Drug Abuse., eds. Behavioral studies of drug-exposed offspring: Methodological issues in human and animal research. Rockville, MD: U.S. Dept. of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 1996.

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Book chapters on the topic "Newborn infants Effect of drugs on Case studies"

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Wittenstrom, Kim, Donald J. Baumann, John D. Fluke, J. Christopher Graham, and Joyce James. "The Impact of Drugs, Infants, Single Mothers, and Relatives on Reunification." In Decision-Making and Judgment in Child Welfare and Protection, 194–214. Oxford University Press, 2020. http://dx.doi.org/10.1093/oso/9780190059538.003.0009.

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Using a Decision-Making Ecology (DME) approach and proportional hazards models, the study reviewed in this chapter isolated four case factor profiles that interacted strongly with race and resulted in disparate reunification outcomes for African American children compared with Anglos. The four interrelated factors were drug involvement, a solo infant case, single mothers, and relative placements. A cohort of 21,763 children from the Texas Department of Family and Protective Services who were placed for the first time in care, who were under 13, and were either Anglo or African American were followed for 20 months or more post entry into care. Starting with an initial model consisting of main effects only and consistent with other studies, African American children had a 12% lower hazard rate of reunification compared to Anglo children. However, when a set of case profiles involving combinations of single parents, single infants, drug involvements, and kinship placements were crossed with race, the magnitude of the effect of race on hazard rates fanned out from no difference to as much as 68% that of Anglo children. The results show that racial disparities in outcomes resulting from complex, contextual decision-making cannot be modeled well with simple main effects models.
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