About

Samia Aleem is an Assistant Professor of Pediatrics at Duke University, specializing in Neonatology. She is based at the Duke Department of Pediatrics located at 2424 Erwin Road, Hock Plaza I, Durham, NC 27705. Her role involves clinical care, research, and education within the field of neonatology, contributing to the advancement of neonatal health and care practices.

Research topics

• Medicine
• Internal medicine
• Physical therapy
• Dermatology
• Biology
• Environmental health
• Microbiology
• Emergency medicine
• Intensive care medicine

Selected publications

• Well-being in parents of infants with neurological conditions: from birth to 6 months after discharge

  Journal of Perinatology · 2026-03-30

  articleSenior author
  PublisherDOI

• Medical treatment of gastroesophageal reflux in the neonatal intensive care unit: current practice

  Journal of Perinatology · 2025-02-22 · 3 citations

  articleOpen accessSenior author
  PublisherOA PDFDOI

• The Complex Challenge of Defining Bronchopulmonary Dysplasia

  PEDIATRICS · 2025-10-14

  article1st authorCorresponding

  Bronchopulmonary dysplasia (BPD), a condition that has been a focus of neonatal research for decades, is the most common chronic morbidity in extremely preterm infants.1 While the incidence of other neonatal complications has declined, the incidence of BPD has remained consistently high, affecting 30 to 60% of surviving extremely preterm infants.1,2 Evaluating BPD incidence over time is challenging because clinicians and clinical trialists base BPD diagnosis on management parameters, rather than specific structural, anatomic, or functional physiologic measures. This reliance on a management-based definition has led to the emergence of a number of proposed definitions, as reviewed in this issue of Pediatrics by Katz et al.3 Although development of a more robust, non-management-based definition would be ideal, the procedures necessary for such diagnosis, such as lung biopsy or pulmonary function tests,4 are either too invasive, not widely available, or cost-prohibitive.5 Thus, management-based definitions of BPD prevail.Identifying the “best” definition of BPD has been a long-standing point of contention in neonatology. One of the main drivers of the iterative attempts at a consensus BPD definition has been the overall goal of identifying a definition of BPD in the initial neonatal intensive care unit (NICU) hospitalization that improves the prediction of long-term respiratory outcomes in extremely preterm infants. Being able to predict long-term respiratory outcomes is critical, as it provides an opportunity to identify high-risk infants for timely interventions, allows clinicians to counsel parents about future expectations, and informs the development and assessment of clinical trials of interventions that affect these outcomes.6 Measuring these long-term outcomes to validate a BPD definition in the initial hospitalization can be time-consuming, cost-intensive, and difficult to conduct broadly, especially in outpatient settings, and even more so during childhood.6 However, because these NICU hospitalization management-based BPD definitions are associated with long-term respiratory and neurodevelopmental morbidities, BPD is frequently used as a surrogate predictor for these outcomes.7In their systematic review of 18 studies, Katz et al compared the prognostic accuracy of multiple BPD definitions on long-term outcomes in preterm infants with a mean gestational age under 30 weeks and a mean birth weight less than 1500 g.3 The authors used sensitivity, specificity, negative and positive predictive values, and c-statistics to assess predictive accuracy. Pulmonary outcomes of interest included respiratory hospitalizations and a group of categorical respiratory morbidities comprising asthma, wheezing, tracheostomy, and the use of supplemental oxygen. The authors also assessed associations between BPD and neurodevelopmental impairment (NDI) and late death. Late death was defined as that occurring after the diagnosis of BPD and before follow-up and was evaluated separately and as a composite outcome with respiratory outcomes or NDI. The systematic review revealed that none of the definitions compared was consistently superior to the others in predicting the outcomes of interest.This study highlights several areas of concern for clinicians and researchers interested in the consistent application of BPD diagnosis to inform long-term outcome prediction. The definitions reviewed by Katz et al incorporate the use of oxygen or respiratory support at varying time points of assessment.3 However, the need for supplemental oxygen or respiratory support is influenced by several factors, including clinicians’ subjective assessment of respiratory status, oxygen saturation targets, immaturity of the central nervous system, the infant’s growth trajectory, and use of medications such as diuretics and bronchodilators, which affect the respiratory system.8 In clinical practice, different definitions are applied based on local guidelines and preferences, and geographical location.9,10 Some definitions include the use of oxygen or respiratory support for at least 28 days; others require an assessment at 36- or 40-week postmenstrual age.10 In practical use, manually recording and counting days of support is burdensome and open to human error. Another issue to be considered is whether definitions established in one era should be applied to infants from a different era. Over time, our understanding of the pathophysiology of BPD has evolved, as has the availability of prevention therapeutics, such as antenatal steroids and surfactant, and the modalities of respiratory support at our disposal.4 In essence, the earlier definitions of BPD may reflect a different phenotype from “new” BPD, and comparing outcomes from different eras does not provide the most accurate information about contemporary surviving preterm infants.11Like the BPD definitions, the long-term outcomes that were assessed in the review by Katz et al differed considerably across the examined studies.3 In particular, the definitions of NDI were variable in all of the included studies. BPD has frequently been used as a predictor of neurodevelopmental outcomes in survivors, but as emphasized by Katz et al, ultimately these outcomes in preterm infants are influenced by numerous other factors and cannot be well predicted by BPD alone.3 For example, NICU medication management, including type and timing of corticosteroid exposure, affects the incidence of both BPD and NDI; understanding the potential clinical impact of such interventions underscores the need for a consistent definition.12 Given the challenges of predicting neurodevelopmental outcomes, prediction of long-term respiratory outcomes may be more achievable and has been the focus of definitions published in 2017 by the Canadian Neonatal Network and in 2019 by the Neonatal Research Network.13,14 As the field of neonatology looks to harmonize the definition of BPD, the authors also highlight the need for a core set of respiratory and neurodevelopmental outcomes that are consistently evaluated in clinical trials and follow-up studies. Using input from key stakeholders, clinically meaningful outcomes should be established that are patient-centered and impact the quality of life of both the patients and their families.15,16The potential benefits of an ideal BPD definition are clear, but how can we arrive at one? Unless neonatologists reach a consensus as a community, how will we accurately know that we are improving the care and outcomes of this vulnerable population? If the ideal definition of BPD were one that is developed based on its high predictive value of respiratory outcomes, should this definition be updated over time to evolve with changes in outcomes and neonatal care, including diagnostic tests and “big data” analyses? Can we agree on a definition that is sufficiently predictive of a consensus collection of long-term outcomes, is simple enough to verify, interpret, and apply consistently, is meaningful to families, and reflects the underlying pathophysiology of the lung disease? Or is our field fixated on something that is not fully achievable? We believe that neonatologists should, and can, agree on a universal definition of BPD and hold each other accountable for its consistent use across research endeavors and clinical metric reporting. While we may never arrive at a “perfect” management-based definition, consistency in the use of an agreed-on, validated definition will allow us at last to “compare apples to apples” and identify true changes and differences that may be associated with differing clinical practices. It is likely that such a definition will inevitably need updating because of the discovery and availability of new tools that can improve data assessment. However, with the consistent use of one definition at a time, the neonatal field will be a step closer to impacting the rate of long-term respiratory morbidity.Thank you to Dr P. Brian Smith and Dr C. Michael Cotten for their reviews of the manuscript.

  PublisherDOI

• Efficacy and safety of dapsone in adult immune thrombocytopenia: a systematic review and meta-analysis

  European journal of medical research · 2025-12-11

  articleOpen access

  BACKGROUND: Immune thrombocytopenia (ITP) is an autoimmune condition often managed with corticosteroids, intravenous immunoglobulins, or thrombopoietin receptor agonists. In settings where these therapies are inaccessible or contraindicated, dapsone an older antimicrobial agent with immunomodulatory effects has been proposed as an alternative, though its comparative effectiveness and safety profile remain inadequately defined. OBJECTIVES: This study systematically reviews and synthesizes existing data to assess the efficacy and tolerability of dapsone in adult patients with ITP. METHODS: Following PRISMA guidelines, a literature search across PubMed, Embase, and Cochrane databases identified observational studies and interventional trials evaluating dapsone in ITP, including comparisons with standard treatments. Primary outcomes included complete and overall response rates, hemoglobin variation, relapse frequency, and adverse effects. Risk of bias was evaluated using the Newcastle-Ottawa Scale and Cochrane tools. Meta-analysis was conducted using RevMan and R (meta/metafor). RESULTS: Four eligible studies encompassing over 270 patients were analyzed. The pooled complete response rate was 28%, while the overall response rate reached 47%. Dapsone use was associated with a modest decline in hemoglobin levels with a mean decrease of 1.74 g/dL, and relapse occurred in approximately 21% of patients. Adverse effects most commonly hemolytic anemia and methemoglobinemia were reported in 18% of patients, though generally not severe. Heterogeneity was explored through leave-one-out sensitivity analyses. CONCLUSIONS: Dapsone demonstrates moderate efficacy and an acceptable safety profile in adult ITP patients, especially in resource-limited contexts. While it may not match thrombopoietin agonists in preventing relapse, its low cost and oral administration offer practical advantages. Further large-scale randomized trials are warranted to clarify its role in ITP management.

  PublisherDOI

• Apnea After 2-Month Vaccinations in Hospitalized Preterm Infants

  JAMA Pediatrics · 2025-01-06 · 5 citations

  articleOpen access

  Importance: Preterm infants are recommended to receive most vaccinations at the same postnatal age as term infants. Studies have inconsistently observed an increased risk for postvaccination apnea in preterm infants. Objective: To compare the proportions of hospitalized preterm infants with apnea and other adverse events in the 48 hours after 2-month vaccinations vs after no vaccinations. Design, Setting, and Participants: This randomized, open-label clinical trial took place at 3 US neonatal intensive care units between August 2018 and October 2021. Infants between 6 and 12 weeks' postnatal age who were born at less than 33 weeks' gestational age and were eligible to receive 2-month vaccines were included. Intervention: Infants were randomized 1:1 to vaccinated (received vaccines within 12 hours of randomization) or unvaccinated (no vaccines received during the study period) groups. Cardiorespiratory data were collected during the 48 hours after vaccination or randomization (unvaccinated group). Main Outcomes and Measures: The primary outcome was apnea, defined as a respiration pause greater than 20 seconds or a respiration pause greater than 15 seconds with associated bradycardia less than 80 beats per minute. Other outcomes included the number and duration of apnea episodes, serious adverse events, respiratory support escalation, and receipt of positive pressure ventilation. Results: Of 223 randomized infants (117 female; median [range] gestational age, 27.6 [23.0-32.9] weeks), 107 (48%) were vaccinated, and 116 (52%) were unvaccinated. For 2 infants in the vaccinated group, the primary outcome was unable to be assessed. The proportion of infants with 1 or more apnea event was 25 of 105 (24%) in the vaccinated group vs 12 of 116 (10%) in the unvaccinated group (adjusted odds ratio, 2.70; 95% CI, 1.27 to 5.73; P = .01). The mean number of apneic episodes did not significantly differ (model point estimate of difference, 0.54; 95% CI, -0.12 to 1.21) between the vaccinated (2.72) and unvaccinated (2.00) groups. The mean duration of apneic episodes did not significantly differ (model point estimate of difference, 4.6; 95% CI, -5.4 to 14.7) between the vaccinated (27.7) and unvaccinated (32.3) groups. No serious adverse events occurred during the 48-hour monitoring period. Other outcomes were not significantly different between groups. Conclusions and Relevance: In hospitalized preterm infants, the odds of apnea within 48 hours were higher after 2-month vaccinations vs after no vaccinations. The similar number and duration of apneic events and lack of serious adverse events suggest that current vaccination recommendations for hospitalized preterm infants are appropriate. Neonatal clinicians should continue providing evidence-based anticipatory guidance about postvaccination apnea risk. Trial Registration: ClinicalTrials.gov Identifier: NCT03530124.

  PublisherOA PDFDOI

• Factors Affecting Non Compliance to Medication in Epileptic Patients

  Pakistan Journal of Health Sciences · 2025-05-31 · 1 citations

  articleOpen access

  Non-compliance with antiepileptic medications is a significant concern, leading to poor seizure control, increased hospitalization, and higher healthcare costs. Objective: To identify factors contributing to non-compliance among epileptic patients. Methods: A cross-sectional study was conducted at Akhtar Saeed Trust Hospital, Lahore, from July 2023 to March 2024, including 200 epileptic patients aged 18-60 years identified as non-compliant using the Morisky Medication Adherence Scale (MMAS-4) Patients with psychiatric illnesses, hearing problems, or those pregnant/lactating were excluded. Data on demographics and contributing factors (e.g., high costs, forgetfulness, unemployment) were collected via structured proformas. Statistical analysis using SPSS version 25.0 included descriptive statistics and stratified analyses to explore relationships between factors and demographics, with significance at p < 0.05. Results: Of 200 patients, 67.5% were male. High cost (57.5%) was the leading factor, followed by forgetfulness (55.0%), prolonged treatment duration (32.5%), unemployment (29.5%), and medication complexity (16.5%). Monthly household income significantly influenced these factors; high costs and prolonged treatment duration were predominant in low-income groups (p < 0.001). Forgetfulness was uniformly reported across socio-economic strata (p = 0.094). Conclusions: High medication costs and forgetfulness are primary contributors to non-compliance among epileptic patients. Strategies like cost reduction, simplified regimens, and reminder interventions are essential to enhance adherence and improve clinical outcomes.

  PublisherOA PDFDOI

• Early Intratracheal Budesonide to Reduce Bronchopulmonary Dysplasia in Extremely Preterm Infants

  JAMA · 2025-09-30 · 11 citations

  articleOpen access

  Importance: Extremely preterm infants are at high risk for bronchopulmonary dysplasia (BPD) and death. Multiple small randomized clinical trials showed that a combination of budesonide with surfactant compared with surfactant alone reduced BPD or death. Objective: To determine if early intratracheal administration of a combination of budesonide (0.25 mg/kg) mixed with surfactant, compared with surfactant alone, reduces physiologic BPD or death by 36 weeks' postmenstrual age in extremely preterm infants. Design, Setting, and Participants: This double-masked randomized clinical trial was conducted from April 2021 to June 2024 in the 17 centers of the United States Neonatal Research Network. Infants 22 to 28 weeks' gestation or 401 to 1000 g birth weight were enrolled after clinical decision to give surfactant, with the first dose of surfactant being study drug (prior surfactant was an exclusion criterion). Interventions: Infants were randomly allocated 1:1 to receive 1 to 2 doses of budesonide + surfactant (poractant alfa) or surfactant alone via endotracheal tube within 50 hours of birth. Main Outcomes and Measures: The primary outcome was physiologic BPD or death by 36 weeks' postmenstrual age. There were 5 prespecified secondary outcomes and multiple prespecified exploratory and safety outcomes. Results: The trial was stopped with 641 infants enrolled (55.3% of 1160 planned; mean birth weight, 810 g [SD, 256 g]; gestational age, 25.9 weeks [SD, 1.9 weeks]), because interim analysis at 50% enrollment reached the prespecified futility threshold. The incidence of BPD or death was 68.5% in the budesonide + surfactant group and 67.9% in the surfactant-alone group (adjusted relative risk [RR], 1.00 [95% CI, 0.90-1.11]). No differences were noted in mortality (15.3% vs 13.2%; adjusted RR, 1.13 [95% CI, 0.78-1.64]) or BPD among survivors to 36 weeks' postmenstrual age (62.9% vs 63.0%; adjusted RR, 0.99 [95% CI, 0.87-1.12]). More infants who received budesonide + surfactant compared with surfactant alone had hyperglycemia (66.7% vs 49.8%; adjusted RR, 1.33 [95% CI, 1.17-1.51]). Conclusions and Relevance: In this large multicenter trial, the combination of budesonide with surfactant did not reduce the risk of BPD or death at 36 weeks' postmenstrual age in extremely preterm infants. Trial Registration: ClinicalTrials.gov Identifier: NCT04545866.

  PublisherOA PDFDOI

• Mentoring the future of neonatology: program director advice for fellowship applicants and their advisors

  Journal of Perinatology · 2025-09-20 · 1 citations

  article
  PublisherDOI

• A phase 1b randomized, multicenter, dose determination trial of zelpultide alfa (recombinant human surfactant protein D) in preterm neonates at high risk of developing bronchopulmonary dysplasia

  Frontiers in Pediatrics · 2025-09-12 · 5 citations

  articleOpen access

  Background Bronchopulmonary dysplasia (BPD) ranks among the most severe long-term complications of prematurity. Surfactant protein D, not present in commercial surfactant, regulates the innate immune response of the lungs by clearing infectious pathogens and limiting pulmonary inflammation and inflammatory injury. We aimed to assess the safety and tolerability of zelpultide alfa vs. air-sham when added to the standard of care in preterm neonates at risk of BPD. Efficacy was a secondary outcome. Methods A phase 1b, randomized, double-blind, dose-determination study was conducted that enrolled intubated, mechanically ventilated preterm neonates who required ≥1 surfactant treatment within 96 h of birth. Initially, eight subjects [25–28 6 / 7 weeks gestational age (GA)] were randomized 3:1 to receive up to two doses of intratracheal zelpultide alfa at each dosing level (2, 4, or 6 mg/kg) or air-sham 24 h apart. Moreover, 12 additional subjects (23–28 6 / 7 weeks GA) were randomized 3:1 to receive the highest-tolerated dose of zelpultide alfa, or air-sham, once daily for up to 7 days. Results In total, 37 subjects were randomized and treated. Zelpultide alfa, at its highest dose of 6 mg/kg, had a favorable safety profile. Furthermore, 92.9% of zelpultide alfa subjects vs. 100.0% of those that received air-sham experienced ≥1 adverse event. The mortality rate was 21% in the zelpultide alfa group and 0% in the air-sham group, although no deaths were related to the study drug. The incidence of BPD was 32.1% vs. 66.7%, the incidence of BPD or death was 54% and 67%, and time on mechanical ventilation was 17.7 vs. 25.8 days in the zelpultide alfa group compared to the air-sham group, respectively. Conclusions This study endorses the safety and tolerability of zelpultide alfa up to 6 mg/kg (≤7 days) and reinforces the need for further clinical development of zelpultide alfa as a therapy for preventing BPD. Clinical Trial Registration : https://clinicaltrials.gov/study/NCT04662151?cond=BPD&term=At-100&rank=1 , identifier NCT04662151.

  PublisherOA PDFDOI

• Rituximab plus lenalidomide (R²) versus standard therapies in follicular lymphoma: A systematic review and meta-analysis of randomized controlled trials

  Blood · 2025-11-03

  articleOpen access

  Abstract Introduction: Follicular lymphoma (FL) is a common indolent non-Hodgkin lymphoma characterized by frequent relapses and the need for effective yet tolerable treatment strategies. Combining rituximab with lenalidomide (R²) has emerged as a promising chemo-free regimen aimed at improving patient outcomes while minimizing toxicity. However, the comparative efficacy and safety of R² versus standard therapies, including rituximab/lenalidomide monotherapies and chemoimmunotherapy (BR/RCHOP), remain to be fully clarified. Methods: A PRISMA-compliant systematic review was conducted using PubMed, Embase, and Cochrane Central through May 2025 to identify randomized controlled trials comparing rituximab plus lenalidomide (R²) to standard treatments in follicular lymphoma. Outcomes included complete response (CR), overall response rate (ORR), partial response (PR), 2-year progression-free survival (PFS), 3-year overall survival (OS), and adverse events. Data were extracted and assessed for risk of bias using ROB 2.0. Pooled analyses were conducted using Review Manager version 5.4.1 with random-effects models; heterogeneity was assessed using I², and publication bias was evaluated via Egger's test. Results: Four randomized controlled trials (n = 1,315) evaluating rituximab plus lenalidomide (R²) versus control in follicular lymphoma were included. Baseline characteristics were well-balanced across arms, with a median age range of 55–64 years, 48–52% male patients, and most presenting with advanced-stage disease (Ann Arbor III/IV: 70–90%) and high tumor burden (FLIPI ≥2: 60–75%). Rituximab plus lenalidomide was associated with a non-significant improvement in 2-year progression-free survival (Risk Ratio [RR] = 1.50; 95% CI: 0.50–4.50; P = 0.254), with substantial heterogeneity (I² = 85.3%), which resolved and reached statistical significance upon exclusion of one outlier study (RR = 2.05; 95% CI: 1.18–3.55; P = 0.038; I² = 0%). Overall survival at 3 years was comparable between treatment arms (RR = 1.00; 95% CI: 0.96–1.05; P = 0.593; I² = 0%). Overall response rates (RR = 1.09; 95% CI: 0.81–1.49; P = 0.697; I² = 65.2%) and complete response rates (RR = 0.78; 95% CI: 0.25–2.47; P = 0.549; I² = 82.2%) were similar between groups, with persistently high heterogeneity in the latter. A non-significant trend favoring the R² regimen was observed for partial responses (RR = 1.20; 95% CI: 0.74–1.94; P = 0.325; I² = 24.9%). Hematologic toxicities were more frequent with R², though not statistically significant, including any-grade neutropenia (RR = 1.56; 95% CI: 0.22–11.09; P = 0.434; I² = 75.8%), grade ≥3 neutropenia (RR = 1.39; 95% CI: 0.12–16.03; P = 0.620; I² = 86.9%), any-grade thrombocytopenia (RR = 1.09; 95% CI: 0.19–6.10; P = 0.855; I² = 13.6%), grade ≥3 thrombocytopenia (RR = 1.71; 95% CI: 0.34–8.59; P = 0.289; I² = 0%), any-grade anemia (RR = 1.20; 95% CI: 0.17–8.41; P = 0.727; I² = 60.1%), and grade ≥3 anemia (RR = 2.96; 95% CI: 0.12–71.57; P = 0.504). Non-hematologic toxicities were more prominent with R², particularly skin reactions (RR = 2.79; 95% CI: 1.08–7.17; P = 0.033; I² = 65.2%) and diarrhea (RR = 1.98; 95% CI: 1.65–2.38; P = 0.004; I² = 0%), both of which reached statistical significance. Other adverse events, including fatigue, nausea/vomiting, and elevated aminotransferases, were similar between groups with no statistically significant differences. Publication bias was suggested for progression-free survival (Egger's test p = 0.04), while reporting appeared balanced for other outcomes Conclusion: This meta-analysis of randomized controlled trials suggests that rituximab plus lenalidomide may improve progression-free survival in follicular lymphoma, particularly after accounting for heterogeneity, while demonstrating comparable overall survival and response rates to standard treatments, validating a chemotherapy-free option. These findings support R² as an effective treatment option with a distinct safety profile, warranting further investigation and individualized clinical consideration.

  PublisherOA PDFDOI

Frequent coauthors

• Rachel G. Greenberg

  Duke University

  18 shared

• Iffat Hassan

  Government Medical College

  12 shared

• Zulfiqar A Bhutta

  SickKids Foundation

  9 shared

• Evan R. Myers

  Duke University

  8 shared

• Qazi Masood

  7 shared

• Kristin E. D. Weimer

  Duke Medical Center

  5 shared

• P. Brian Smith

  5 shared

• Scott M. Palmer

  Clinical Research Institute

  5 shared

Education

• MHS

  School of Medicine, Duke University

  2020

• MBBS

  Dow University of Health Sciences

  2011