scholarly journals Randomized Controlled Trials in Very Preterm Infants: Does Inclusion in the Study Result in Any Long-Term Benefit?

Neonatology ◽  
2014 ◽  
Vol 106 (2) ◽  
pp. 114-119 ◽  
Author(s):  
Christoph M. Rüegger ◽  
Andrea Kraus ◽  
Brigitte Koller ◽  
Giancarlo Natalucci ◽  
Beatrice Latal ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Preterm Infants ◽  
Controlled Trials ◽  
Very Preterm Infants ◽  
Very Preterm ◽  
Randomized Controlled ◽  
Term Benefit

scholarly journals Effect of family-centered care interventions on motor and neurobehavior development of very preterm infants: a protocol for systematic review

2021 ◽  
Author(s):  
Manasa Kolibylu Raghupathy ◽  
Bhamini Krishna Rao ◽  
Shubha R Nayak ◽  
Alicia J Spittle ◽  
Shradha S Parsekar
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Preterm Infants ◽  
Controlled Trials ◽  
Family Centered Care ◽  
Very Preterm Infants ◽  
Very Preterm ◽  
Randomized Controlled ◽  
Centered Care ◽  
Family Centered

Abstract Background: Globally, very preterm birth is a health concern leading to various developmental difficulties such as poor motor and/or cognitive function. For infants born very preterm, Family-Centered Care (FCC) might promote developmental skills over the time in an appropriate enriched environment. The purpose of this study is to systematically review and assess the evidence of FCC interventions on the motor and neurobehavioral development in very preterm infants. Additionally, this review aims to determine the factors that might affect infant development.Methods: Systematic review will be carried out by including a) quasi-randomized controlled trials and randomized controlled trials b) of very preterm born infants (born < 32 weeks of gestation) and their primary caregivers will be included in the review c) who received FCC based interventions such as collaborative interaction between a healthcare professional and a parent, home program, home visits, and parent education and d) measure motor and neurobehavioral function. Electronic databases such as Scopus, PubMed, EMBASE, Cochrane Library, Web of Science, CINAHL, and PsycINFO will be searched using database-specific terms. Additionally, searches will be carried out in ProQuest, and references of included studies will be searched. Two review authors, independently, will conduct the screening, data extraction, and critical appraisal of included studies. If possible, a meta-analysis will be undertaken to assess the effect of the FCC on the motor and neurobehavior of premature infants.Conclusion: The review will provide insights regarding the effect of the FCC on preterm infants. This systematic review will guide the clinicians on the feasibility of practicing FCC that might support and promote the integration of parents into various rehabilitation settings.Systematic review registration: Protocol has been registered in PROSPERO on August 26, 2020.

scholarly journals Effect of family-centered care interventions on motor and neurobehavior development of very preterm infants: a protocol for systematic review

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Manasa Kolibylu Raghupathy ◽  
Bhamini Krishna Rao ◽  
Shubha R. Nayak ◽  
Alicia J. Spittle ◽  
Shradha S. Parsekar
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Preterm Infants ◽  
Controlled Trials ◽  
Family Centered Care ◽  
Very Preterm Infants ◽  
Very Preterm ◽  
Randomized Controlled ◽  
Centered Care ◽  
Family Centered

Abstract Background Globally, very preterm birth is a health concern leading to various developmental difficulties such as poor motor and/or cognitive function. For infants born very preterm, family-centered care (FCC) might promote developmental skills over the time in an appropriate enriched environment. The purpose of this study is to systematically review and assess the evidence of FCC interventions on the motor and neurobehavioral development in very preterm infants. Additionally, this review aims to determine the factors that might affect infant development. Methods Systematic review will be carried out by including (a) quasi-randomized controlled trials and randomized controlled trials (b) of very preterm born infants (born < 32 weeks of gestation), and their primary caregivers will be included in the review (c) who received FCC-based interventions such as collaborative interaction between a healthcare professional and a parent, home program, home visits, and parent education, and (d) measure motor and neurobehavioral function. Electronic databases such as Scopus, PubMed, Embase, Cochrane Library, Web of Science, CINAHL, and PsycINFO will be searched using database-specific terms. Additionally, searches will be carried out in ProQuest, and references of included studies will be searched. Two review authors, independently, will conduct the screening, data extraction, and critical appraisal of included studies. If possible, a meta-analysis will be undertaken to assess the effect of the FCC on the motor and neurobehavior of premature infants. Conclusion The review will provide insights regarding the effect of the FCC on preterm infants. This systematic review will guide the clinicians on the feasibility of practicing FCC that might support and promote the integration of parents into various rehabilitation settings. Systematic review registration Protocol has been registered in PROSPERO on August 26, 2020.

Clinical trials of multiple sclerosis therapies: improvements to demonstrate long-term patient benefit

2009 ◽  
Vol 15 (8) ◽  
pp. 951-958 ◽  
Author(s):  
WM Carroll
Keyword(s):  
Multiple Sclerosis ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Patient Benefit ◽  
Short Term ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Term Benefit

Background The therapeutic goal for multiple sclerosis (MS) is to achieve a better long-term outcome. However, since available data come from short-term studies, it is important to review the evidence that current therapies provide long-term benefit. Method and results Long-term data from both registry studies and long-term follow-up studies, and efficacy treatment data were reviewed. Registry data show that the course of MS is predictable after a certain level of disability is reached, indicating that short-term efficacy data from randomized, controlled trials provide evidence of long-term benefit. Long-term studies of patients originally enrolled in pivotal randomized, controlled trials consistently show that delayed or discontinued treatment provides less benefit than continuous therapy. The 16-Year Long-Term Follow-Up Study of interferon beta-1b (IFNβ-1b; Betaferon®/Betaseron®) therapy had the highest ascertainment of long-term follow-up efforts of the pivotal trials, which led to the currently approved therapies. Disability scores at the start of treatment were predictive of their current disability scores. In addition, this 16-year study showed an excellent safety profile with no unexpected side effects to IFNβ-1b and a lower mortality rate after 16 years compared with those receiving placebo treatment during the pivotal study (6 deaths vs 20 deaths). Conclusion This article reviews the key data and provides recommendations for optimizing clinical studies in MS to demonstrate long-term patient benefit.

scholarly journals Maternal Vaginal Ureaplasma spp. Colonization in Early Pregnancy Is Associated with Adverse Short- and Long-Term Outcome of Very Preterm Infants

Children ◽  
2021 ◽  
Vol 8 (4) ◽  
pp. 276
Author(s):  
Judith Rittenschober-Böhm ◽  
Tanja Habermüller ◽  
Thomas Waldhoer ◽  
Renate Fuiko ◽  
Stefan M. Schulz ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Early Pregnancy ◽  
Short Term ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Very Preterm Infants ◽  
Very Preterm ◽  
Vaginal Colonization ◽  
Short And Long Term

Vaginal colonization with Ureaplasma (U.) spp. has been shown to be associated with adverse pregnancy outcome; however, data on neonatal outcome are scarce. The aim of the study was to investigate whether maternal vaginal colonization with U. spp. in early pregnancy represents a risk factor for adverse short- or long-term outcome of preterm infants. Previously, 4330 pregnant women were enrolled in an observational multicenter study, analyzing the association between vaginal U. spp. colonization and spontaneous preterm birth. U. spp. colonization was diagnosed via PCR analysis from vaginal swabs. For this study, data on short-term outcome were collected from medical records and long-term outcome was examined via Bayley Scales of Infant Development at 24 months adjusted age. Two-hundred-and-thirty-eight children were born <33 weeks gestational age. After exclusion due to asphyxia, malformations, and lost-to-follow-up, data on short-term and long-term outcome were available from 222 and 92 infants, respectively. Results show a significant association between vaginal U. spp. colonization and severe intraventricular hemorrhage (10.4% vs. 2.6%, p = 0.03), retinopathy of prematurity (21.7% vs. 10.3%, p = 0.03), and adverse psychomotor outcome (24.3% vs. 1.8%, OR 13.154, 95%CI 1.6,110.2, p = 0.005). The data suggest an association between vaginal U. spp. colonization in early pregnancy and adverse short- and long-term outcome of very preterm infants.

scholarly journals Patent ductus arteriosus, systemic NT-proBNP concentrations and development of bronchopulmonary dysplasia in very preterm infants: retrospective data analysis from a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Solomiia Potsiurko ◽  
Dmytro Dobryanskyy ◽  
Lesya Sekretar
Keyword(s):  
Randomized Controlled Trial ◽  
Patent Ductus Arteriosus ◽  
Preterm Infants ◽  
Roc Curve ◽  
Controlled Trial ◽  
Ductus Arteriosus ◽  
Very Preterm Infants ◽  
Very Preterm ◽  
Randomized Controlled ◽  
Patent Ductus

Abstract Background Patent ductus arteriosus (PDA) is a common complication in very preterm infants. It is known that there is an association between PDA and development of bronchopulmonary dysplasia (BPD) or death before the postmenstrual age (PMA) of 36 weeks, but this association remains one of the most controversial aspects of the problem. The study aimed to evaluate the relationship between PDA, serum NT-proBNP levels at 2–3 and 8–9 days of life, and BPD/death in very preterm infants. Methods Data of 52 preterm infants with a gestational age < 32 weeks, chronological age < 72 h, and PDA diameter > 1.5 mm, enrolled in a randomized controlled trial, were used for the retrospective analysis. All patients underwent daily echocardiographic and two serum NT-proBNP measurements within the first 10 days after birth. Two groups of infants were formed retrospectively at PMA of 36 weeks depending on the outcome, BPD (n = 18)/death (n = 7) or survival without BPD (n = 27). Receiver operator characteristic (ROC) curve was used to evaluate the predictive performance of serum NT-proBNP levels for BPD/death occurrence. Results The percentage of infants who received pharmacological treatment for PDA did not differ between the groups. Based on the area under the ROC curve, serum NT-proBNP levels on the 2–3 day of life (AUC = 0.71; 95% confidence interval (CI): 0.56–0.9; p = 0.014)) and on the 8–9 day of life (AUC = 0.76; 95% CI: 0.6–0.9; p = 0.002) could reliably predict BPD/death in very preterm infants who had PDA diameter > 1.5 mm in the first 72 h of life. Hemodynamically significant PDA (hsPDA) was significantly more often detected in newborns with BPD/death, however, treatment of infants with hsPDA did not reduce the incidence of BPD/death. Conclusions In very preterm infants with PDA > 1.5 mm at the age of 24–48 h, serum NT-proBNP concentration could reliably predict the development of BPD or death, regardless of the persistence of PDA, with the highest diagnostic value at 8–9 days. Trial registration This study is registered in ClinicalTrials.gov - NCT03860428 on March 4, 2019.

scholarly journals Nutrition in infancy and long-term risk of obesity: evidence from 2 randomized controlled trials

2010 ◽  
Vol 92 (5) ◽  
pp. 1133-1144 ◽  
Author(s):  
Atul Singhal ◽  
Kathy Kennedy ◽  
Julie Lanigan ◽  
Mary Fewtrell ◽  
Tim J Cole ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Randomized Controlled
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