cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.57982/ye7z-n835
title: Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW) Current Experience: Infant Exposure and Treatment

description: Despite prevalence of infants exposed to opioids prenatally and who develop NOWS, little evidence exists on the best approaches to identify, monitor, and treat these infants. As a result, there is considerable practice variation across and even within centers. This study systematically collected existing patient-level data, using retrospective chart review, to determine current practices in the care of infants with NOWS at sites associated with ISPCTN and NRN. Data was abstracted from the infants’ records as well as the mothers’ records when her records were available at the site. As a result of the analysis, we have a better understanding of the current practices, and practice variation that exists between these sites. These findings determined the priorities for, and informed the design of, two new clinical trials to improve the care and outcomes for infants with NOWS.
DOI: 10.57982/3e2d-mk60
title: Pediatric Intensive Care Unit Bereavement Study

description: Grief is expected after the death of a loved one. Most bereaved persons work through the grief process successfully. Others develop complicated grief, a pattern of extreme or prolonged symptoms that are associated with adverse mental and physical health outcomes. A multicenter, prospective survey study was conducted to investigate the extent of complicated grief symptoms and associated risk factors among parents whose child died in a pediatric intensive care unit (PICU). Surveys were conducted over the phone or sent in the mail at 6 months and 18 months after the child’s death.
DOI: 10.57982/t528-hd21
title: Males, Antioxidants, and Infertility Trial

description: Males, Antioxidants, and Infertility (MOXI) Trial is to examine whether treatment of infertile males with an antioxidant formulation improves male fertility. The central hypothesis is that treatment of infertile males with antioxidants will improve sperm structure and function, resulting in higher fertilization rates and improved embryo development, leading to higher pregnancy and live birth rates. Findings from this research will be significant in that they will likely lead to an effective, non-hormonal treatment modality for male infertility. An effective treatment for men would also reduce the treatment burden on the female partner, lower costs, and provide effective alternatives to couples with religious or ethical contraindications to assisted reproductive technologies (ART). If antioxidants do not improve pregnancy rates, but do improve sperm motility and DNA integrity, they could allow for couples with male factor infertility to use less intensive therapies such as intrauterine insemination.
DOI: 10.57982/ksnn-d514
title: Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence

description: The overall objective of this study is to estimate the effect of combined midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to MUS alone on successful treatment of Mixed Urinary Incontinence (MUI) symptoms.
DOI: 10.57982/tv48-cx68
title: Pharmacokinetics and Relative Bioavailability of a Liquid Formulation of Hydroxyurea in Pediatric Patients with Sickle Cell Anemia

description: This was an open label assessment of hydroxyurea pharmacokinetics and relative bioavailability conducted in two independent cohorts of pediatric patients with sickle cell anemia or sickle beta-zero thalassemia. A total of 42 participant were enrolled, out of which 39 were enrolled and dosed. A one-compartment population PK model was successfully developed to describe the time course of hydroxyurea concentrations after oral administration in sickle cell anemia participants from both study arms. The relative bioavailability analysis showed very similar pharmacokinetics for peroral liquid and capsule formulations. No adverse events (AEs) were classified as being caused by the study drug, and no AEs led to study drug interruption. Lastly, no significant changes from baseline in laboratory values, vital signs, or physical examination results were found. Hydroxyurea was well tolerated as evidenced by safety monitoring and reporting.
DOI: 10.57982/1hc5-jc06
title: Azithromycin to Prevent Bronchopulmonary Dysplasia in Ureaplasma-Infected Preterms

description: Ureaplasma (UU) respiratory tract colonization is a risk factor for BPD in preterm infants. We hypothesized that azithromycin (AZM) therapy will prevent BPD in UU-colonized preterms. We conducted a Phase IIb RCT of 20 mg/kg x3d IV AZM in infants 24^0-28^6 wks GA randomly assigned within 4d following birth. The primary efficacy outcome was UU-free survival. Secondary outcomes included mortality, UU clearance, physiologic BPD at 36 wks PMA, and 2 yr corrected age serious respiratory morbidity (SRM) and neurodevelopmental impairment (NDI). 121 randomized infants (AZM, N=60; placebo, N=61) were enrolled. 44(36%) were UU+ (AZM, N=19; placebo, N=25). UU-free survival was 55/60 [92%(95%CI, 82%-97%)] for AZM compared to 37/61 [61%(95%CI, 48%-73%)] for placebo. AZM eradicated UU in all UU+AZM infants, but 21/25(84%) UU+placebo infants remained culture+. There were no significant differences in death/SRM (34.8% vs 30.4%, p=0.67) or death/moderate-severe NDI (47% vs 33%, p=0.11) between AZM and placebo groups at 2 yrs.
DOI: 10.57982/rnts-2x43
title: Controlling Anal Incontinence by Performing Anal Exercises with Biofeedback or Loperamide: a Randomized Placebo Controlled Trial

description: The goals of this trial are to compare the use of loperamide to oral placebo and to compare the use of anal sphincter exercise training with biofeedback to usual care (educational pamphlet) in the treatment of women suffering from fecal incontinence (FI). We will test the following null hypotheses: there is no difference in outcomes between women randomized to loperamide and women randomized to oral placebo for treatment of FI; there is no difference in outcomes between women randomized to anal sphincter exercises with biofeedback and women randomized to usual care (educational pamphlet) for FI treatment; there is no difference between women randomized to both treatments together and women randomized to either FI treatment alone; and there is no correlation between anal manometry measurements and digital anal squeeze strength or measures of FI severity and bother.
DOI: 10.57982/0p9k-rf96
title: Extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss

description: This study extends the follow-up of women in the OPTIMAL study, a randomized trial to compare sacrospinous ligament fixation (SSLF) to uterosacral ligament suspension (ULS), and to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence (SUI). The primary aims are to compare SSLF and ULS for the following outcomes up to 5 years after surgery in women with Stage 2-4 prolapse involving the vaginal apex or uterus and SUI: time to surgical failure; the long-term functional and health-related quality of life, adjusted for PMT treatment group; the annual and cumulative incidence, resolution, and persistence of pelvic floor symptoms, adjusted for PMT treatment group; and determine whether exposure to a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process will improve enrollment and/or retention.
DOI: 10.57982/mkqa-bj37
title: Psychosocial Outcomes of Multiple Gestations

description: This study looks at the money issues and way people think and feel in families who have had children (aged 2–12) by assisted reproductive technologies. They looked at families who had a single child, twins, and other multiple births who received infertility services at centers which are a part of the Cooperative Multicenter Reproductive Medicine Network funded by the National Institutes of Health. Among the family groups, differences between the families who had a single child, twins, and other multiple births were found regarding the mothers’ employment, parenting stress, impact on the family, depression, and child behavior. The findings suggest the families are doing well, but compared to families with single children, families with twins or other multiple births had more family impacts. The authors hope that this information will improve information available to families when they have to make decisions about assisted reproductive technologies.
DOI: 10.57982/m14h-jc69
title: Antibiotic Safety in Infants with Complicated Intra-Abdominal Infections – Clindamycin

description: NICHD-2013-ABS01 was a prospective, open-label, partially randomized, multicenter trial. The primary objective of this study was to evaluate the safety of drug regimens consisting of ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, and gentamycin in assigned or standard of care groups of infants with complicated intra-abdominal infections. Secondary objectives included evaluations of efficacy and population pharmacokinetics (PK). Results demonstrate that clindamycin therapy at the protocol-specified doses was safe for premature infants with complicated intra-abdominal infections. Only one adverse event was attributed to the study drug, and mortality within 30 days post-treatment was 7% in the cohort receiving the ampicillin, gentamycin, and clindamycin drug regimen (Group 2). None of the outcomes of special interest were attributable to clindamycin. Therapeutic success was achieved in 87% of participants. Collected PK data validated the protocol-specified dosing regimen.
DOI: 10.57982/0p5n-m082
title: Registry of Pregnancies Conceived following Exposure to Ovulation Stimulation Medications

description: Researchers conducted this prospective cohort study to analyze the development of children conceived from non-IVF infertility treatments consisting of gonadotropins, clomiphene, or letrozole. The study included children of women with polycystic ovary syndrome who conceived with letrozole (LTZ) or clomiphene (CC) in the PPCOS II study or women with unexplained infertility (AMIGOS study) who conceived with LTZ, CC, or gonadotropin (GN). At least one follow-up assessment from the two infertility trials included 185 children from 160 families. No significant differences were found among the three groups at any time point with respect to abnormal scores on the Ages and Stages Developmental Questionnaire. Growth and cognitive developmental disparities among children conceived with first-line infertility treatments, including LTZ, are fairly low and possibly attributable to discrepancies in multiple rates of pregnancy.
DOI: 10.57982/yb8e-hv23
title: Refractory Overactive Bladder: Sacral Neuromodulation v. Botulinum Toxin Assessment

description: The purpose of this randomized, open-label, active-control trial was to compare the effectiveness of intra-detrusor botulinum toxin A (Botox A�, Allergan) versus sacral neuromodulation (InterStim�, Medtronic) for the treatment of refractory urge urinary incontinence. In addition, the study evaluated select technical attributes of the interventions as well as the effect of these two interventions on other lower urinary tract and pelvic floor symptoms.
DOI: 10.57982/hs6z-4j46
title: Evaluation of Systemic Hypothermia Initiated After 6 Hours of Age in Infants ? 36 Weeks Gestation with Hypoxic-Ischemic Encephalopathy: A Bayesian Evaluation

description: This study was a randomized, controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ? 36 weeks gestational age with hypoxic-ischemic encephalopathy will reduce the incidence of death or disability at 18-22 months of age.
DOI: 10.57982/dqeq-xm59
title: Early Blood Pressure Management in Extremely Preterm Infants Feasibility Pilot Study

description: This was a time-limited prospective observational study of all infants born at a NRN center between 23 and 26 weeks gestational age. All clinical decisions made for these babies were at the discretion of the attending neonatologist/infant care team according to standard practice at each institution. Data were collected on blood pressure management in the first 24 postnatal hours for each infant.
DOI: 10.57982/1m4d-1k29
title: Safety and Immunogenicity of Anti-pneumococcal Vaccines in HIV-infected Pregnant Women

description: NICHD P1091 was a multi-center, Phase II, randomized, double-blinded, placebo-controlled study of HIV-infected pregnant women on HAART who were in the second or third trimester of pregnancy and of their infants. The study was designed to investigate the safety, reactogenicity, immunogenicity, transplacental antibody transfer, and interference with infant responses to childhood vaccination of maternal vaccination with PCV-10 or PPV-23 by comparison with placebo. Mothers were randomized to receive PCV-10, PPV-23, or placebo in a blinded fashion. They were followed for safety, immunogenicity, and vaccine-specific anti-capsular pneumococcus (PNC) antibody persistence until 24 weeks post-delivery. Women who received placebo were randomized to a second study step and received PCV-10 or PPV-23 at 24 weeks post-delivery. Antibody responses to the vaccine administered 6 months postpartum were measured. All infants received PCV-10 vaccinations per local standard of care.
DOI: 10.57982/gnnr-qv11
title: Early-Onset Sepsis an NICHD/CDC Surveillance Study

description: This observational study was a surveillance of all infants born at NRN centers to identify all newborns who are diagnosed with early-onset sepsis (EOS) and/or meningitis. The purpose of the study was to establish current hospital-based rates of EOS among term and preterm infants in the era of intrapartum antibiotic prophylaxis; monitor the organisms associated with EOS and meningitis; compare asymptomatic and symptomatic infants by gestational age and pathogen; and monitor sepsis-associated mortality rates by pathogen group.
DOI: 10.57982/gmyg-nz51
title: Early-Onset Sepsis an NICHD/CDC Surveillance Study II

description: The primary purpose of this study was to determine rates of early-onset neonatal infection in term and preterm infants in the era of maternal intrapartum antibiotic prophylaxis to prevent vertical transmission of group B streptococcal disease. Early-onset infection comprises early-onset sepsis (EOS) and/or early-onset meningitis (EOM) and is defined as isolation of a pathogen from blood or cerebrospinal fluid (CSF) obtained within 72 hours of birth and provision of appropriate antibiotic treatment for 5 or more days (or <5 days if death occurs while receiving antibiotic therapy). The antimicrobial susceptibility patterns of organisms associated with EOS and EOM were evaluated. Case controls were also identified.
DOI: 10.57982/6enr-8046
title: A Prospective, Randomized, Double-Blind, Controlled Clinical Trial of the Effects of Oxygen Tension on Clinical In Vitro Fertilization Outcomes

description: This was a multi-center, prospective, double-blind clinical trial of physiologic (5%) oxygen tension in culture media vs. standard of care, atmospheric (SOC, 20%) oxygen tension with 840 eligible couples recruited to participate. The randomization scheme was coordinated through the central data coordinating center, and the randomization was stratified by age group of the woman (18-34, 35-37, 38-39, and 40-42) and each participating site. Couples were randomized to either have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere or in the currently widely used atmospheric (20%) oxygen atmosphere.
DOI: 10.57982/79ez-0x87
title: Translating an Adult Ventilator Computer Protocol to Pediatric Critical Care

description: The purpose of this study was to evaluate a strategy for ventilator management (ventilator management protocol) that was developed in adult intensive care units for patients with Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS). The goal was to investigate the changes related to the size and scale of usual ventilator management practices and to determine acceptability of recommendations from a computer protocol for ventilator management. Results found that ventilator management varies substantially in children with acute respiratory distress syndrome. Analysis also showed that although acceptance rates for a computer protocol were good, there was little consensus regarding the size/scale of ventilator setting changes for children with pediatric acute respiratory distress syndrome.
DOI: 10.57982/4jjc-1s13
title: The Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants

description: This�2x2 factorial designed randomized clinical trial�compared the use of continuous positive airway pressure initiated at�birth�to the administration of surfactant within 1 hour of�birth�for premature infants�born�at 24 to 27 weeks gestation. In addition, these infants within 2 hours of�birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This�study�helped determine whether or not these two management strategies affect survival without bronchopulmonary dysplasia (also called chronic lung disease) and survival without severe retinopathy of prematurity (an eye disorder that can lead to blindness).
DOI: 10.57982/ax6z-m584
title: Human Microbiome Study-ESTEEM

description: The overarching aim of the HMS-ESTEEM study was to describe the role that the urinary microbiome plays in disorders of the lower genitourinary system, namely, the female genitourinary microbiome. The primary aim of the study evaluated whether the urinary microbiome differs between women with mixed urinary incontinence (MUI) and unaffected controls. There were 212 women (128 affected and 84 controls) who participated in the study and had catheterized urine specimens, vaginal specimens sent for culture, and DNA analysis. From the catheterized urine samples obtained, v4–6 regions of the 16S rRNA gene were sequenced to identify bacteria. Women with MUI and controls did not differ in overall Lactobacillus predominance. In younger women, urinary bacterial community-types differentiated MUI from controls.
DOI: 10.57982/av7d-r684
title: Baclofen Efficacy and Safety Trials - A Multi-center Retrospective Chart Review of the Pediatric Population Using Oral Baclofen to Manage the Spasticity of Cerebral Palsy

description: This was a multi-center retrospective chart review of pediatric subjects started on oral baclofen as treatment for spasticity of cerebral palsy (CP). Primary objectives included describing the characteristics of this population and the safety, effectiveness, and treatment course of oral baclofen. Subjects at seven sites with eligible charts were screened to identify 185 subjects who had started on oral baclofen. All 185 subjects had a full chart review and were included in the safety population; and all 185 subjects had documentation in their chart of both a baseline and post-baseline report of effectiveness (Movement/Tone Abnormality assessments), and were included in the efficacy population. Oral baclofen was used to manage spasticity of CP in pediatric subjects who mainly had 4 limb involvement, were on either none or one additional tone medication, and had low gross motor function and manual ability. As shown by the safety analysis, oral baclofen was safe and well tolerated in subjects with severe CP.
DOI: 10.57982/ra7e-8508
title: Pediatric ECMO and Cefepime

description: In critically ill patients not receiving extracorporeal membrane oxygenation (ECMO), pharmacokinetic (PK) studies have demonstrated significant changes to drug exposure through interactions between the patient, pathology, and the drug. The ECMO system introduces additional variables, which are inherent to the circuit itself, as well as the systemic inflammation that results from use of an extracorporeal circuit. The amount of variability in drug disposition and pharmacokinetics with use of ECMO is largely unknown. The objective of this study was to gain preliminary data on the impact of ECMO on the pharmacokinetics of cefepime administered as standard of care to infants. A PK model was developed to evaluate cefepime disposition differences due to ECMO. This study found that cefepime clearance was reduced in pediatric patients treated with extracorporeal membrane oxygenation compared with previously reported values in children not receiving extracorporeal membrane oxygenation.
DOI: 10.57982/xgkw-re45
title: Inhaled Nitric Oxide Use in Pediatric Intensive Care

description: Acute lung injury (ALI) occurs in approximately 9% of mechanically ventilated children with 80% progressing to acute respiratory distress syndrome (ARDS). Inhaled nitric oxide (iNO) is an important therapy for neonates with persistent pulmonary hypertension, older children with pulmonary hypertension, and patients with congenital heart disease. It is hypothesized that iNO should benefit patients with ALI/ARDS by improving oxygenation. With this prospective observational trial, we found that clinician responsiveness to improved oxygenation was associated with less ventilator days. Algorithms to standardize ventilator management may improve signal to noise ratios in future trials enabling better assessment of the effect of inhaled nitric oxide on patient outcomes. Additionally, confining studies to more selective patient populations, such as those with right ventricular dysfunction, may be required.
DOI: 10.57982/aeve-8753
title: Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas

description: The purpose of this study was to learn whether a daily 81 mg dose of aspirin given to Nulliparas, beginning between 6-13 weeks of pregnancy, and continuing until 36 weeks of pregnancy, can reduce the risk of preterm birth. Nulliparous women appeared to be an ideal population since they will not undergo special interventions in an attempt to avoid preterm birth and are high risk pregnancies. The study design was a randomized, placebo-controlled, double-blinded multicenter clinical trial to assess the efficacy of Low Dose Aspirin (LDA) in the reduction of preterm birth.  Women were randomized equally to receive either daily LDA (81 mg) or a placebo beginning between 6 0/7 weeks and 13 6/7 weeks Gestational Age (GA) and continued until 36 0/7 weeks GA or delivery. The primary outcome of this study was preterm birth, which will be defined as delivery at or after 20 0/7 weeks and prior to 37 0/7 weeks determined by comparing actual delivery date to the projected Estimated Due Date (EDD).
DOI: 10.57982/8bk2-my95
title: Microbiome, Virome and Host Responses Preceding Ventilator-Associated Pneumonia

description: Microbiome, Virome and Host Responses Preceding Ventilator-Associated Pneumonia (VAP) was a prospective longitudinal observational study of high risk mechanically ventilated children with systematic bacterial and viral analyses of the respiratory tract along with proteomic evaluation of the host response to determine whether specific taxa and patterns of bacterial microbiota contribute to ventilator-associated pneumonia (VAP) risk and whether bacterial communities are modulated by viral infection and host immune responses to increase risk of VAP. Analysis found that in mechanically ventilated children, microbial factors were subtly different at intubation between those who did and did not develop VAP, and changes over time were marginally associated with VAP risk, suggesting other factors may contribute to VAP.