Intelligence at Six Years in Relation to Neonatal Bilirubin Level: Follow-up of The National Institute of Child Health and Human Development Clinical Trial of Phototherapy

PEDIATRICS ◽  
1991 ◽  
Vol 87 (6) ◽  
pp. 797-805
Author(s):  
Peter C. Scheidt ◽  
Barry I. Graubard ◽  
Howard J. Hoffman ◽  
Dolores A. Bryla ◽  
Karin B. Nelson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Birth Weight ◽  
Child Health ◽  
Human Development ◽  
Bilirubin Level ◽  
Controlled Trial ◽  
Full Scale ◽  
The Central Nervous System ◽  
Bilirubin Toxicity

Results of the National Institute of Child Health and Human Development Randomized Controlled Trial of Phototherapy were examined for the relationship of neonatal bilirubin level to neurological and developmental outcome at 6-year follow-up. This analysis focused on 224 control children with birth weight of less than 2000 g. Bilirubin levels were maintained below previously specified levels by the use of exchange transfusion only (24%). Rates of cerebral palsy were not significantly higher for children with elevated maximum bilirubin level than for those whose level remained low. No association was evident between maximum bilirubin level and IQ (Full Scale, Verbal, or Performance) by simple correlation analysis (r = -.087, P = .2 for Full Scale) or by multiple linear regression adjusting for factors that covary with IQ (β = -.15, P = .58). IQ was not associated with mean bilirubin level, time and duration of exposure to bilirubin, or measures of bilirubin-albumin binding. Thus, over the range of bilirubin levels permitted in this clinical trial, there was no evidence of bilirubin toxicity to the central nervous system. Measures used to control the level of bilirubin in low birth weight neonates appear to prevent effectively the risk of bilirubin-induced neurotoxicity.

The NICHD Phototherapy Study

PEDIATRICS ◽  
1990 ◽  
Vol 86 (5) ◽  
pp. 811-812
Author(s):  
PETER C. SCHEIDT ◽  
DOLORES A. BRYLA ◽  
KARIN B. NELSON ◽  
DEBORAH G. HIRTZ ◽  
HOWARD J. HOFFMAN
Keyword(s):  
Clinical Trial ◽  
Brain Injury ◽  
Child Health ◽  
Human Development ◽  
Brain Damage ◽  
Exchange Transfusion ◽  
Adverse Outcome ◽  
Neonatal Hyperbilirubinemia

In Reply.— Dr Perlman expresses concern that readers of "Phototherapy for Neonatal Hyperbilirubinemia: Six-Year Follow-up of the National Institute of Child Health and Human Development Clinical Trial"1 could interpret our conclusions that phototherapy demonstrated a beneficial reduction or prevention of brain damage. We neither stated or meant to imply that phototherapy was observed to prevent brain injury. The statement in our concluding paragraph that phototherapy was "at least as effective as management with exchange transfusion" refers to "control of neonatal hyperbilirubinemia without evidence of adverse outcome" earlier in the sentence.

scholarly journals Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Marouf Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Kamal Alaa Eddin ◽  
Khaled Cheha
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Controlled Trial ◽  
Helicobacter Pylori Infection ◽  
First Line ◽  
Link Type ◽  
Syrian Population

Abstract Background Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. Settings and design An open-label, randomised, parallel, superiority clinical trial. Methods We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment. Results Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454–4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394–3.774]. We didn’t report serious adverse effects. Conclusions Levofloxacin concomitant therapy wasn’t superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population. Trial registration We registered this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier-NCT04348786, date:29-January-2020).

scholarly journals Clinical Outcomes of Computational Virtual Mapping-Guided Catheter Ablation in Patients With Persistent Atrial Fibrillation: A Multicenter Prospective Randomized Clinical Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Yong-Soo Baek ◽  
Oh-Seok Kwon ◽  
Byounghyun Lim ◽  
Song-Yi Yang ◽  
Je-Wook Park ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Catheter Ablation ◽  
Computational Modeling ◽  
Controlled Trial ◽  
Dominant Frequency ◽  
Complication Rates ◽  
Clinical Recurrence ◽  
Significant Difference

Background: Clinical recurrence after atrial fibrillation catheter ablation (AFCA) still remains high in patients with persistent AF (PeAF). We investigated whether an extra-pulmonary vein (PV) ablation targeting the dominant frequency (DF) extracted from electroanatomical map–integrated AF computational modeling improves the AFCA rhythm outcome in patients with PeAF.Methods: In this open-label, randomized, multi-center, controlled trial, 170 patients with PeAF were randomized at a 1:1 ratio to the computational modeling-guided virtual DF (V-DF) ablation and empirical PV isolation (E-PVI) groups. We generated a virtual dominant frequency (DF) map based on the atrial substrate map obtained during the clinical AF ablation procedure using computational modeling. This simulation was possible within the time of the PVI procedure. V-DF group underwent extra-PV V-DF ablation in addition to PVI, but DF information was not notified to the operators from the core lab in the E-PVI group.Results: After a mean follow-up period of 16.3 ± 5.3 months, the clinical recurrence rate was significantly lower in the V-DF than with E-PVI group (P = 0.018, log-rank). Recurrences appearing as atrial tachycardias (P = 0.145) and the cardioversion rates (P = 0.362) did not significantly differ between the groups. At the final follow-up, sinus rhythm was maintained without any AADs in 74.7% in the V-DF group and 48.2% in the E-PVI group (P < 0.001). No significant difference was found in the major complication rates (P = 0.489) or total procedure time (P = 0.513) between the groups. The V-DF ablation was independently associated with a reduced AF recurrence after AFCA [hazard ratio: 0.51 (95% confidence interval: 0.30–0.88); P = 0.016].Conclusions: The computational modeling-guided V-DF ablation improved the rhythm outcome of AFCA in patients with PeAF.Clinical Trial Registration: Clinical Research Information Service, CRIS identifier: KCT0003613.

scholarly journals Guided meditation for vision acuity training on adolescent myopia: study protocol for an open-label, prospective, multicenter, randomized controlled trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Yibo Li ◽  
Lili Zhu ◽  
Raoying Wang ◽  
Xingyue Yang ◽  
Xinqi Jiang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Visual Acuity ◽  
Controlled Trial ◽  
Control Group ◽  
Health Maintenance ◽  
Ocular Symptoms ◽  
Thought Disorders ◽  
Multicenter Randomized Controlled Trial ◽  
Distant Visual Acuity

Abstract Background Currently, the population with myopia climbs steadily, and is developing toward younger age, posing a great concern to the health of adolescents. Myopia in severe cases can cause irreversible consequences such as glaucoma, blindness, and other complications. At present, the solutions for myopia are glasses, medication, and surgery. This study aims to investigate the role of a physiotherapy category based on guided meditation for vision acuity training on adolescent myopia. Methods This is a prospective, randomized, multicenter clinical trial. One thousand one hundred forty primary and secondary school students aged 8–18 years old from 27 schools will be recruited and randomly divided into an experimental and a control group at a ratio of 2:1 in two phases, with a training period of 30 days in each phase and a follow-up period of 3 months. No interventions will be conducted during the follow-up period, nor will other interventions employed. Inclusion criteria will meet the diagnostic criteria for simple myopia and −6.00D ≤ spherical lenses ≤ −0.50D and cylindrical lenses ≤1.50D. The primary observation index will be to compare the statistical differences in distant visual acuity between the two groups; the secondary observation indexes will be ocular symptoms (mainly including eye fatigue, dryness, pain, double vision, neck pain, thought disorders, and lags in response), diopter, and astigmatism. Discussion The purpose of this two-phase trial is to compare the clinical effectiveness of focused vision-guided meditation with Chinese eye exercises that are also non-pharmacological, non-invasive interventions for myopia, and to maximize the benefit to the subjects. The results will indicate whether the training based on focused vision-guided meditation has the ability to improve distant visual acuity, relieve ocular symptoms, and ameliorate diopter. In addition, this trial will provide clinical efficacy of the training, which is expected to provide meaningful data for vision rehabilitation. At the same time, the vision acuity training method, which is permeated with the concept of Traditional Chinese Medicine (TCM) rehabilitation and health maintenance, will be applied to achieve the goal of preventing or alleviating myopic development and reducing myopia rate. Trial registration Chinese Clinical Trial Registry ChiCTR2000038642. Registered on 26 September 2020

Neonatology—Science or Art?

PEDIATRICS ◽  
1991 ◽  
Vol 88 (4) ◽  
pp. 880-880
Keyword(s):  
Birth Weight ◽  
Child Health ◽  
Low Birth Weight ◽  
Human Development ◽  
Very Low Birth Weight ◽  
Research Network ◽  
Exact Science ◽  
Weight Outcomes

To the Editor.— The authors of the National Institute of Child Health and Human Development Neonatal Research network report1 of very low birth weight outcomes deserve a lot of praise for providing a survey of neonatal practices. But they are much too polite. In the discussion of "important intercenter variation as well as differences in the philosophy of care," the authors mildly note, "the practice of neonatal medicine remains in part an art rather than an exact science."

Very Low Birth Weight Outcomes of the National Institute of Child Health and Human Development Neonatal Network

PEDIATRICS ◽  
1991 ◽  
Vol 87 (5) ◽  
pp. 587-597 ◽  
Author(s):  
Maureen Hack ◽  
Jeffrey D. Horbar ◽  
Michael H. Malloy ◽  
Linda Wright ◽  
Jon E. Tyson ◽  
...  
Keyword(s):  
Birth Weight ◽  
Child Health ◽  
Low Birth Weight ◽  
Human Development ◽  
Neonatal Intensive Care ◽  
Very Low Birth Weight ◽  
Ductus Arteriosus ◽  
Neonatal Morbidity ◽  
Neonatal Outcomes ◽  
Weight Outcomes

This report describes the neonatal outcomes of 1765 very low birth weight (<1500 g) infants delivered from November 1987 through October 1988 at the seven participating centers of the National Institute of Child Health and Human Development Neonatal Intensive Care Network. Survival was 34% at <751 g birth weight (range between centers 20% to 55%), 66% at 751 through 1000 g (range 42% to 75%), 87% at 1001 through 1250 g (range 84% to 91%), and 93% at 1251 through 1500 g (range 89% to 98%). By obstetric measures of gestation, survival was 23% at 23 weeks (range 0% to 33%), 34% at 24 weeks (range 10% to 57%), and 54% at 25 weeks (range 30% to 72%). Neonatal morbidity included respiratory distress (67%), symptomatic patent ductus arteriosus (25%), necrotizing enterocolitis (6%), septicemia (17%), meningitis (2%), urinary tract infection (4%), and intraventricular hemorrhage (45%, 18% grade III and IV). Morbidity increased with decreasing birth weight. Oxygen was administered for ≥28 days to 79% of <751-g birth weight infants (range between centers 67% to 100%), 45% of 751-through 1000-g infants (range 20% to 68%), and 13% of 1001- through 1500-g infants (range 5% to 23%). Ventilator support for ≥28 days was given to 68% of infants at <751 g, 29% at 751 through 1000 g, and 4% at >1000 g. Hospital stay was 59 days for survivors vs 15 days for infants who died. Sixty-nine percent of survivors had subnormal (<10th percentile) weight at discharge. The data demonstrate important intercenter variation of current neonatal outcomes, as well as differences in philosophy of care and definition and prevalence of morbidity.

Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth

2021 ◽  
pp. 38-42
Author(s):  
Emily A. Oliver ◽  
Amanda Roman-Camargo
Keyword(s):  
Preterm Birth ◽  
Child Health ◽  
Human Development ◽  
Intraventricular Hemorrhage ◽  
Controlled Trial ◽  
Supplemental Oxygen ◽  
Spontaneous Preterm Birth ◽  
Increased Risk ◽  
Hydroxyprogesterone Caproate ◽  
History Of

Women with a history of spontaneous preterm birth have an increased risk of recurrent preterm birth. In this randomized placebo-controlled trial funded by the National Institute of Child Health and Human Development, patients between 16 and 20 weeks of gestation with a history of spontaneous preterm birth were administered intramuscular 17 alpha-hydroxyprogesterone caproate (17P) or placebo, weekly until 36 weeks of gestation. Treatment with 17P significantly reduced the rate of preterm birth (36.3% vs. 54.9%, p <0.001). Rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen were all significantly decreased in the 17P group. In women with a history of spontaneous preterm birth, weekly 17P decreases the rate of recurrent preterm birth.

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