Pediatrics Commons^™

Bovine Lactoferrin To Prevent Neonatal Infections In Low-Birth-Weight Newborns In Pakistan: Protocol For A Three-Arm Double-Blind Randomized Controlled Trial, Shabina Ariff, Sajid Bashir Soofi, Almas Aamir, Michelle D'Almeida, Arzina Aziz Ali, Ashraful Alam, Michael Dibley

Department of Paediatrics and Child Health

Background: Sepsis is a common and severe complication in premature neonates, particularly those born with low birth weights (<2500 >g). Neonatal sepsis is steadily emerging as a leading cause of neonatal mortality in Pakistan. Lactoferrin is a natural product with broad-spectrum antimicrobial properties and glycoprotein that is actively involved in innate immune host responses. Clinical trials have revealed its protective effect on sepsis, but lactoferrin dosage, duration, and role in the prevention of sepsis are still uncertain.
Objective: We aimed to establish the efficacy of bovine lactoferrin in the prevention of late-onset sepsis and to determine the optimal dose and …

Feasibility, Usability And Acceptability Of Paediatric Lung Ultrasound Among Healthcare Providers And Caregivers For The Diagnosis Of Childhood Pneumonia In Resource-Constrained Settings: A Qualitative Study, Atif Riaz, Olga Cambaco, Laura Elizabeth Ellington, Jennifer L. Lenahan, Khatia Munguambe, Usma Mehmood, Sana Qaisar, Benazir Baloch, Muhammad Imran Nisar, Fyezah Jehan

Department of Paediatrics and Child Health

Objectives: Paediatric pneumonia burden and mortality are highest in low-income and middle-income countries (LMIC). Paediatric lung ultrasound (LUS) has emerged as a promising diagnostic tool for pneumonia in LMIC. Despite a growing evidence base for LUS use in paediatric pneumonia diagnosis, little is known about its potential for successful implementation in LMIC. Our objectives were to evaluate the feasibility, usability and acceptability of LUS in the diagnosis of paediatric pneumonia.
Design: Prospective qualitative study using semistructured interviews SETTING: Two referral hospitals in Mozambique and Pakistan PARTICIPANTS: A total of 21 healthcare providers (HCPs) and 20 caregivers were enrolled.
Results: HCPs …

Implementation And Evaluation Of A Social Media-Based Communication Strategy To Enhance Employee Engagement: Experiences From A Children's Hospital, Pakistan, Muneera A. Rasheed, Alma Arshad Hookmani, Sana Waleed, H Sundus Fatima, Soha Siddiqui, Muhammad Khurram, Babar Hasan

Department of Paediatrics and Child Health

Social media can complement organizational communication strategy which is integral to employee engagement. However, successful case studies which can allow replication are limited. The objective of the study is to describe the design, implementation, and evaluation of a social media-based communication strategy in a tertiary care hospital in Pakistan. The leadership of the pediatric service line developed an intervention plan to engage the employees with the newly reframed vision to improve patient and family experience. An online communication platform-Facebook page-was created for all employees of the pediatric service line. The strategy to influence employees was based on Cialdini's six principles …

Development And Feasibility Testing Of A Play-Based Psychosocial Intervention For Reduced Patient Stress In A Pediatric Care Setting: Experiences From Pakistan, Muneera A. Rasheed, Vardah Bharuchi, Waliyah Mughis, Ayesha Hussain

Department of Paediatrics and Child Health

Background: Hospitalization can be a source of great stress for children and their families. In high-income countries, there are specialized staff to help children cope using different techniques including play. However, it is a major challenge in low and middle-income countries (LMIC) due to financial constraints and untrained human resource. The objective of study was to develop and test the feasibility and acceptance of a psychology trainee-delivered model postulated on employing play as a means of enhancing child-parent interactions leading to reduced stress during hospitalization.
Methods: This study was conducted in the paediatric ward of a tertiary care private hospital …

Effects Of Neonatal Nutrition Interventions On Neonatal Mortality And Child Health And Development Outcomes: A Systematic Review, Aamer Imdad, Faseeha Rehman, Evans Davis, Deepika Ranjit, Gamael S. S. Surin, Suzanna L. Attia, Sarah Lawler, Abigail A. Smith, Zulfiqar A. Bhutta

Pediatrics Faculty Publications

Background
The last two decades have seen a significant decrease in mortality for children < 5 years of age in low and middle‐income countries (LMICs); however, neonatal (age, 0–28 days) mortality has not decreased at the same rate. We assessed three neonatal nutritional interventions that have the potential of reducing morbidity and mortality during infancy in LMICs.

Objectives
To determine the efficacy and effectiveness of synthetic vitamin A, dextrose oral gel, and probiotic supplementation during the neonatal period.

Search Methods
We conducted electronic searches for relevant studies on the following databases: PubMed, CINAHL, LILACS, SCOPUS, and CENTRAL, Cochrane Central Register for Controlled Trials, up to November 27, 2019.

Selection Criteria
We aimed to include randomized and quasi‐experimental studies. The target population was neonates in LMICs. The interventions included synthetic vitamin A supplementation, oral dextrose gel supplementation, and probiotic supplementation during the neonatal period. …

Impact Of Pediatric Obesity On Diurnal Blood Pressure Assessment And Cardiovascular Risk Markers, Margaret O. Murphy, Hong Huang, John A. Bauer, Aric Schadler, Majd Makhoul, Jody L. Clasey, Aftab S. Chishti, Stefan G. Kiessling

Pediatrics Faculty Publications

Background: The prevalence of hypertension is increasing particularly among obese children and adolescents. Obese children and adolescents with hypertension are likely to remain hypertensive as they reach adulthood and hypertension is linked to an increased risk for cardiovascular disease. Twenty-four-hour ambulatory blood pressure monitoring (ABPM) has become one of the most important tools in diagnosing hypertension in children and adolescents and circadian patterns of blood pressure may be important disease-risk predictors.

Methods: A retrospective chart review was conducted in patients aged 6–21 years who underwent 24-h ABPM at Kentucky Children's Hospital (KCH) from August 2012 through June 2017. Exclusion criteria …

Exploring Pediatric Tele-Rheumatology Practices During Covid-19: A Survey Of The Prcoin Network., Y Ingrid Goh, Danielle R. Bullock, Janalee Taylor, Rajdeep Pooni, Tzielan C. Lee, Sheetal S. Vora, Cagri Yildirim-Toruner, Esi M. Morgan, Nancy Pan, Julia G. Harris, Andrew Warmin, Kendra Wiegand, Jon M. Burnham, Fatima Barbar-Smiley

Manuscripts, Articles, Book Chapters and Other Papers

Healthcare providers were rapidly forced to modify the way they practiced medicine during the coronavirus disease 2019 (COVID-19) pandemic. Many providers transitioned from seeing their patients in person to virtually using telemedicine platforms with limited training and experience using this medium. In pediatric rheumatology, this was further complicated as musculoskeletal exams typically require hands-on assessment of patients. The objective of this study was to examine the adoption of telemedicine into pediatric rheumatology practices, to assess its benefits and challenges, and to gather opinions on its continued use. A survey was sent to the lead representatives of each Pediatric Rheumatology Care …

Effectiveness Of Transcutaneous Bilirubin Measurement In High-Risk Neonates And To Evaluate Validity Of Transcutaneous Bilirubin With Total Serum Bilirubin Levels In Both Low And High-Risk Neonates At A Tertiary Care Center In A Developing Country, Durre Shahwar Khan, Adnan Mirza, Areesh Bhatti, Ali Shabbir Hussain, Batha Tariq, Arjumand Rizvi

Department of Paediatrics and Child Health

Objectives: To evaluate the usefulness of transcutaneous bilirubin (TcBR) nomogram in high-risk neonates and to identify the validity of TcBR and total serum bilirubin (TsBR) in both low and high-risk neonates to guide management in under-resourced settings.
Methodology: A cross-sectional study was conducted at the well-baby nursery of a tertiary care center in Karachi, Pakistan. All neonates admitted in the well-baby nursery with jaundice were stratified into high and low-risk groups. Eighty-seven neonates were included in the low-risk group and 121 neonates in the high-risk group. The usefulness of the TcBR nomogram in high-risk neonates and the validity of TcBR …

Primary Hyperhidrosis In Children: A Review Of Therapeutics, Courtney Remington, Jennifer Ruth, Adelaide A. Hebert

School of Medicine Publications

Primary hyperhidrosis, an idiopathic disease that commonly affects the palms, soles, axillae, or craniofacial region, is characterized by perspiration in excess of what is required for physiologic cooling. This disease begins in childhood or adolescence and negatively impacts emotional, physical, and psychologic well‐being. This review explores current therapeutic options for primary hyperhidrosis in the pediatric population, including topical therapies, oral therapies, non‐surgical and procedural interventions, and adjunctive therapies. In addition, this review identifies new and emerging treatments and highlights the need for further research and therapeutic options for this impactful disease.

Evaluating Opioid Dispensing Rates Among Pediatrics And Young Adults Based On Cures Data Reporting In California From 2015–2019, Michael T. Phan, Courtney Wong, Daniel M. Tomaszewski, Zeev N. Kain, Brooke Jenkins, Candice D. Donaldson, Michelle Fortier, Sun Yang

Pharmacy Faculty Articles and Research

Background

Receipt of opioid prescriptions in pediatric and young adult patients may be a risk factor for future opioid misuse. Data from prescription drug monitoring programs provide insight on outpatient opioid use. In our study, we analyzed the opioid dispensing rates for pediatrics and young adults in California. Methods

A secondary analysis was performed from 2015–2019 using Controlled Utilization Review and Evaluation System data. This database provides dispensing data of controlled substances in California. Patients younger than 25 years who were prescribed opiates were analyzed by county. We further divided them into two groups (children: ≤14 years; adolescents and young …

Sars-Cov-2 Antibodies Detected In Human Breast Milk Postvaccination, Jill K. Baird, Shawn M. Jensen, Walter Urba, Bernard A Fox, Jason R Baird

Articles, Abstracts, and Reports

Importance The SARS-CoV-2 pandemic has infected over a hundred million people worldwide, with almost 2.5 million deaths at the date of this publication. In the United States, Pfizer-BioNTech and Moderna vaccines were first administered to the public starting in December 2020, and no lactating women were included in the initial trials of safety/efficacy. Research on SARS-CoV-2 vaccination in lactating women and the potential transmission of passive immunity to the infant through breast milk is needed to guide patients, clinicians and policy makers during the worldwide effort to curb the spread of this virus.

Objective To determine whether SARS-CoV-2 specific immunoglobins …

Timing Of Cgm Initiation In Pediatric Diabetes: The Cgm Time Trial., Margaret L Lawson, Kate C Verbeeten, Jennilea M Courtney, Brenda J Bradley, Karen Mcassey, Cheril Clarson, Susan Kirsch, Jacqueline R Curtis, Farid H Mahmud, Christine Richardson, Tammy Cooper, Jason Chan, Ken Tang

Paediatrics Publications

OBJECTIVE: To determine whether timing of CGM initiation offering low glucose suspend (LGS) affects CGM adherence in children and youth starting insulin pump therapy.

METHODS: A 5-site RCT of pump-naïve subjects (aged 5-18 years) with type 1 diabetes (T1D) for at least 1 year compared simultaneous pump and CGM initiation offering LGS vs standard pump therapy with CGM initiation delayed for 6 months. Primary outcome was CGM adherence (hours per 28 days) (MiniMed™ Paradigm™ Veo™ system; CareLink Pro™ software) over 6 months after CGM initiation. Secondary outcome HbA1c was measured centrally. Linear mixed-models and ordinary least squares models were fitted …

Improving Access And Mental Health For Youth Using Smart Technologies, Cheryl Forchuk, Sandra Fisman, Jeffrey P. Reiss, Kerry Collins, Julie Eichstedt, Abraham Rudnick, Wanrudee Isaranuwatchai, Jeffrey S. Hoch, Xianbin Wang, Daniel Lizotte, Shona Macpherson, Richard Booth

Paediatrics Publications

The overall objective of this research is to evaluate the use of a mobile health smartphone application (app) to improve the mental health of youth between the ages of 14 and 25 years, with symptoms of anxiety and/or depression. This project includes 122 youth who are accessing outpatient mental health services at one of three hospitals and two community agencies. The youth and care providers are using the Smart technology to enhance care. The technology uses mobile questionnaires (QnairesTM) to help promote self-assessment and track changes to support the plan of care. The youth were provided a smartphone and talk/text/data …

Process Evaluation Of Fruit And Vegetables Distribution Interventions In School-Based Settings: A Systematic Review, Mariam R. Ismail, Jamie A. Seabrook, Jason A. Gilliland

Paediatrics Publications

Despite the importance of process evaluation in program evaluations, research has focused primarily on the effectiveness of fruit and vegetables (FVs) distribution interventions on children's consumption, with little attention given to how these interventions achieve their outcomes. Five bibliographic databases (Embase, PubMed, ProQuest, Scopus, and Web of Science Core Collection) were searched in June 2019 for studies of interventions where the main focus was the implementation of distributed FVs to school-aged children as a snack. The Critical Appraisal Skills Programme (CASP) tool was used to appraise the risk of bias within included studies. Data were extracted based on study characteristics …

Clinical Pharmacology And Dosing Regimen Optimization Of Neonatal Opioid Withdrawal Syndrome Treatments, Fei Tang, Chee M. Ng, Henrietta S. Bada, Markos Leggas

Pharmaceutical Sciences Faculty Publications

In this paper, we review the management of neonatal opioid withdrawal syndrome (NOWS) and clinical pharmacology of primary treatment agents in NOWS, including morphine, methadone, buprenorphine, clonidine, and phenobarbital. Pharmacologic treatment strategies in NOWS have been mostly empirical, and heterogeneity in dosing regimens adds to the difficulty of extrapolating study results to broader patient populations. As population pharmacokinetics (PKs) of pharmacologic agents in NOWS become more well-defined and knowledge of patient-specific factors affecting treatment outcomes continue to accumulate, PK/pharmacodynamic modeling and simulation will be powerful tools to aid the design of optimal dosing regimens at the patient level. Although there …

Is Covid-19 Pushing Us To The Fifth Industrial Revolution (Society 5.0)?, Zouina Sarfraz, Azza Sarfraz, Hamza M. Iftikar, Ramsha Akhund

Department of Paediatrics and Child Health

The coronavirus disease 2019 (COVID-19) pandemic may further promote the development of Industry 4.0 leading to the fifth industrial revolution (Society 5.0). Industry 4.0 technology such as Big Data (BD) and Artificial Intelligence (AI) may lead to a personalized system of healthcare in Pakistan. The final bridge between humans and machines is Society 5.0, also known as the super-smart society that employs AI in healthcare manufacturing and logistics. In this communication, we review various Industry 4.0 and Society 5.0 technologies including robotics and AI being inspected to control the rate of transmission of COVID-19 globally. We demonstrate the applicability of …

Ispd Guidelines For Peritoneal Dialysis In Acute Kidney Injury: 2020 Update (Paediatrics)., Peter Nourse, Brett Cullis, Fredrick Finkelstein, Alp Numanoglu, Bradley A. Warady, Sampson Antwi, Mignon Mcculloch

Manuscripts, Articles, Book Chapters and Other Papers

1.1 Peritoneal dialysis is a suitable renal replacement therapy modality for treatment of acute kidney injury in children. (1C)2. Access and fluid delivery for acute PD in children.2.1 We recommend a Tenckhoff catheter inserted by a surgeon in the operating theatre as the optimal choice for PD access. (1B) (optimal)2.2 Insertion of a PD catheter with an insertion kit and using Seldinger technique is an acceptable alternative. (1C) (optimal)2.3 Interventional radiological placement of PD catheters combining ultrasound and fluoroscopy is an acceptable alternative. (1D) (optimal)2.4 Rigid …

Adolescent Access To Firearms-This Is Definitely Our Lane., Shayla Sullivant, M Denise Dowd

Manuscripts, Articles, Book Chapters and Other Papers

No abstract provided.

The Efficacy And Tolerability Of Auto-Stimulation-Vns In Children With Lennox-Gastaut Syndrome., Sherouk A. Abdelmoity, Ayman Abdelmoity, Sean M. Riordan, Christian Kaufman, Jean-Baptist Lepichon, Ahmed Abdelmoity

Manuscripts, Articles, Book Chapters and Other Papers

OBJECTIVE: Lennox-Gastaut syndrome (LGS) is a severe drug-resistant epilepsy (DRE) of childhood. The Vagus Nerve Stimulator (VNS) is established as a safe and effective treatment for DRE. This study assesses efficacy and tolerability of the auto-stimulation VNS models in pediatric patients with LGS.

METHODS: This is a retrospective chart review of a cohort of pediatric patients (Age 1-18 years old) with LGS implanted with an auto-stimulation VNS model at a single level four pediatric epilepsy center. Patient responder's rate was measured as seizure reduction over baseline and improvements in five quality-of-life measures as reported by the patients and families. Efficacy …

Association Between Preterm-Birth Phenotypes And Differential Morbidity, Growth, And Neurodevelopment At Age 2 Years: Results From The Interbio-21st Newborn Study, Jose Villar, María C. Restrepo-Méndez, Rose Mcgready, Fernando C. Barros, Cesar G. Victora, Shama Munim, Aris T. Papageorghiou, Roseline Ochieng, Rachel Craik, Zulfiqar Ahmed Bhutta

Department of Obstetrics & Gynaecology

Importance: The etiologic complexities of preterm birth remain inadequately understood, which may impede the development of better preventative and treatment measures.
Objective: To examine the association between specific preterm-birth phenotypes and clinical, growth, and neurodevelopmental differences among preterm newborns compared with term newborns up to age 2 years.
Design, setting, and participants: The INTERBIO-21st study included a cohort of preterm and term newborn singletons enrolled between March 2012 and June 2018 from maternity hospitals in 6 countries worldwide who were followed up from birth to age 2 years. All pregnancies were dated by ultrasonography. Data were analyzed from November 2019 …

Relationships Between Disaccharidase Deficiencies, Duodenal Inflammation And Symptom Profile In Children With Abdominal Pain., Jennifer Colombo, Chance S. Friesen, Uttam Garg, Craig A. Friesen, William San Pablo

Manuscripts, Articles, Book Chapters and Other Papers

Abdominal pain has been associated with disaccharidase deficiencies. While relationships with individual symptoms have been assessed, relationships between disaccharidase deficiencies and symptom complexes or inflammation have not been evaluated in this group. The primary aims of the current study were to assess relationships between disaccharidase deficiency and symptoms or symptom complexes and duodenal inflammation, respectively. Patients with abdominal pain who underwent endoscopy with evaluation of disaccharidase activity levels were identified. After excluding all patients with inflammatory bowel disease, celiac disease, H. pylori, or gross endoscopic lesions, patients were evaluated for disaccharidase deficiency frequency. Disaccharidase were compared between patients with and …

Autism And/Or Developmental Delay, Children's Mercy Kansas City

Clinical Pathways (Formally Known As Care Process Models)

No abstract provided.

Phenotype Expression Variability In Children With Gabrb3 Heterozygous Mutations., Abdulhafeez M. Khair, Alana E. Salvucci

Department of Pediatrics Faculty Papers

GABRB3 gene is a recently identified gene located in 15q12 chromosome and encodes for gamma-aminobutyric acid (GABA) receptor subunit beta-3 protein, which is linked to the GABAA receptor. The gene is believed to share a role in inhibitory GABAergic synapses, GABA iron-gated channel function, and possible cellular response to histamine. The β3 subunit is expressed in cerebral grey matter, thalami, hippocampi, and cerebellum, among other structures. Faulty GABRB3 function is linked to several neurological disorders and clinical syndromes. However, the spectrum of such disorders is not yet well known. We present three case reports highlighting the potentially expanding clinical phenotype …

Myelomeningocele, Children's Mercy Kansas City

Clinical Pathways (Formally Known As Care Process Models)

No abstract provided.

Effect Of Crohn's Disease On Villous Length And Cyp3a4 Expression In The Pediatric Small Intestine., Carrie A. Vyhlidal, Brian D. Chapron, Atif Ahmed, Vivekanand Singh, Rebecca Casini, Valentina Shakhnovich

Manuscripts, Articles, Book Chapters and Other Papers

Changes in absorptive capacity and first-pass metabolism in the small intestine affect oral drug bioavailability. Characterization of such changes as a consequence of inflammation is important for developing physiologically-based pharmacokinetic (PBPK) models for inflammatory bowel disease. We sought to elucidate the impact of small intestinal Crohn's disease (CD) on villous length and CYP3A4 expression in children. Freshly frozen duodenal and terminal ileum (TI) biopsies from 107 children (1-19 years) with and without CD were evaluated for active inflammation. Villous length and CYP3A4 mRNA/protein expression were compared among regions of active and inactive inflammation in CD and controls. A twofold reduction …

Growth Of Preterm Very Low Birth Weight Infants Discharged With Weight Of Less Than 1500grams, Yaser Abdallah, Flavia Namiiro, Jolly Nankunda, Jamiru Mugalu, Yvonne Vaucher

Paediatrics and Child Health, East Africa

Early discharge of preterm very low birth weight (VLBW) infants is at times inevitable in low resource settings. The implication of such practice on the growth of this high-risk population is not known. We conducted a retrospective chart review to describe the growth of preterm VLBW infants discharged with a weight of less than 1500 g.

Objectives: To describe the growth of discharged preterm VLBW infants over the first 12 weeks.

Method: Between June 2013 and January 2014; 164 discharged preterm VLBW infants were followed up for 3 months. Among the survivors (132), we identified 111 infant records for …

Readiness To Change And Prospective Effects Of Weight Management Programs In Pediatric Nonalcoholic Fatty Liver Disease., Voytek Slowik, Heather Wasserkrug, Ryan T. Fischer, Mark Connelly, Amanda D. Deacy, Sarah Hampl, James F. Daniel

Manuscripts, Articles, Book Chapters and Other Papers

Non-alcoholic fatty liver disease (NAFLD) is an increasing problem in pediatrics with limited treatment options. We prospectively assessed outcomes in patients managed in a hepatology clinic (HC) alone vs. those managed in combination with a multidisciplinary weight management program (MWMP). We describe each group's readiness to change at the time of NAFLD diagnosis. Patients diagnosed with NAFLD were given a modified Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) at enrollment (T1) to assess readiness to change. They were then followed at 3-9 months (T2) and at 10-15 months (T3). Linear mixed models were used to evaluate changes in …

In Vivo Transplantation Of Human Intestinal Organoids Enhances Select Tight Junction Gene Expression, Mariaelena A Boyle, David J Sequeira, Eoin P Mcneill, Zachary K Criss, Noah F Shroyer, Allison L Speer

Faculty, Staff and Student Publications

BACKGROUND: Short bowel syndrome is a potentially fatal condition with inadequate management options. Tissue-engineered small intestine (TESI) is a promising solution, but confirmation of TESI function will be crucial before human application. We sought to define intestinal epithelial barrier function in human intestinal organoid (HIO)-derived TESI.

MATERIALS AND METHODS: HIOs were generated in vitro from human embryonic stem cells. After 1 mo, HIOs were collected for analysis or transplanted into the kidney capsule of immunocompromised mice. Transplanted HIOs (tHIOs) were harvested for analysis at 4 or 8 wk. Reverse transcription quantitative polymerase chain reaction and immunofluorescent staining were performed for …

Tbx5-Encoded T-Box Transcription Factor 5 Variant T223m Is Associated With Long Qt Syndrome And Pediatric Sudden Cardiac Death, Alexandra M Markunas, Perathu K R Manivannan, Jordan E Ezekian, Agnim Agarwal, William Eisner, Katherina Alsina, Hugh D Allen, Gregory A Wray, Jeffrey J Kim, Xander H T Wehrens, Andrew P Landstrom

Faculty, Staff and Students Publications

Long QT syndrome (LQTS) is a genetic disease resulting in a prolonged QT interval on a resting electrocardiogram, predisposing affected individuals to polymorphic ventricular tachycardia and sudden death. Although a number of genes have been implicated in this disease, nearly one in four individuals exhibiting the LQTS phenotype are genotype-negative. Whole-exome sequencing identified a missense T223M variant in TBX5 that cosegregates with prolonged QT interval in a family with otherwise genotype-negative LQTS and sudden death. The TBX5-T223M variant was absent among large ostensibly healthy populations (gnomAD) and predicted to be pathogenic by in silico modeling based on Panther, PolyPhen-2, Provean, …

Ikaneat: Protocol For A Randomized Controlled Trial Of Megestrol As A Component Of A Pediatric Tube Weaning Protocol., Sarah T. Edwards, Paul E. Hyman, Hayat Mousa, Amanda Bruce, Jose Cocjin, Kelsey Dean, Kandace Fleming, Rebecca Swinburne Romine, Ann M. Davis

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Although tube feeding routinely saves the lives of children who do not eat by mouth, chronic tube feeding can be a burden to patients, caregivers, and families. Very few randomized trials exist regarding the best methods for weaning children from their feeding tubes.

METHODS: The current paper describes a randomized controlled trial of an empirically supported outpatient treatment protocol for moving children from tube to oral eating called iKanEat. Specifically, we describe the methods of randomized double-blind, placebo-controlled trial which includes a 4-week course of megestrol, the only medication used in the iKanEat protocol, to determine whether the addition …