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Barriers to enrollment in a randomized controlled trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants.

ABSTRACT: OBJECTIVE:To analyze reasons for low enrollment in a randomized controlled trial (RCT) of the effect of hydrocortisone for cardiovascular insufficiency on survival without neurodevelopmental impairment (NDI) in term/late preterm newborns. STUDY DESIGN:The original study was a multicenter RCT. Eligibility: ?34 weeks' gestation, <72?h old, mechanically ventilated, receiving inotrope. Primary outcome was NDI at 2 years; infants with diagnoses at high risk for NDI were excluded. This paper presents an analysis of reasons for low patient enrollment. RESULTS:Two hundred and fifty-seven of the 932 otherwise eligible infants received inotropes; however, 207 (81%) had exclusionary diagnoses. Only 12 infants were randomized over 10 months; therefore, the study was terminated. Contributing factors included few eligible infants after exclusions, open-label steroid therapy and a narrow enrollment window. CONCLUSION:Despite an observational study to estimate the population, very few infants were enrolled. Successful RCTs of emergent therapy may require fewer exclusions, a short-term primary outcome, waiver of consent and/or other alternatives.

SUBMITTER: Watterberg KL

PROVIDER: S-EPMC5688018 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Barriers to enrollment in a randomized controlled trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants.

Watterberg K L KL Fernandez E E Walsh M C MC Truog W E WE Stoll B J BJ Sokol G M GM Kennedy K A KA Fraga M V MV Beauman S S SS Carper B B Das A A Duncan A F AF Buss W F WF Gauldin C C Lacy C B CB Sanchez P J PJ Chawla S S Lakshminrusimha S S Cotten C M CM Van Meurs K P KP Poindexter B B BB Bell E F EF Carlo W A WA Devaskar U U Wyckoff M H MH Higgins R D RD

Journal of perinatology : official journal of the California Perinatal Association 20170907 11

<h4>Objective</h4>To analyze reasons for low enrollment in a randomized controlled trial (RCT) of the effect of hydrocortisone for cardiovascular insufficiency on survival without neurodevelopmental impairment (NDI) in term/late preterm newborns.<h4>Study design</h4>The original study was a multicenter RCT. Eligibility: ⩾34 weeks' gestation, <72 h old, mechanically ventilated, receiving inotrope. Primary outcome was NDI at 2 years; infants with diagnoses at high risk for NDI were excluded. This ...[more]

PMID: 28880260

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Project description:BACKGROUND: The evidence on prematurity as 'a priori' a risk for palatal disturbances that increase the need for orthodontic or orthognathic treatment is still weak. Further well-designed clinical studies are needed. The objective of this review is to provide a fundamental analysis of methodologies, confounding factors, and outcomes of studies on palatal development. One focus of this review is the analysis of studies on the palate of the term newborn, since knowing what is 'normal' is a precondition of being able to assess abnormalities. METHODS: A search profile based on Cochrane search strategies applied to 10 medical databases was used to identify existing studies. Articles, mainly those published before 1960, were identified from hand searches in textbooks, encyclopedias, reference lists and bibliographies. Sources in English, German, and French of more than a century were included. Data for term infants were recalculated if particular information about weight, length, or maturity was given. The extracted values, especially those from non-English paper sources, were provided unfiltered for comparison. RESULTS: The search strategy yielded 182 articles, of which 155 articles remained for final analysis. Morphology of the term newborn's palate was of great interest in the first half of the last century. Two general methodologies were used to assess palatal morphology: visual and metrical descriptions. Most of the studies on term infants suffer from lack of reliability tests. The groove system was recognized as the distinctive feature of the infant palate. The shape of the palate of the term infant may vary considerably, both visually and metrically. Gender, race, mode of delivery, and nasal deformities were identified as causes contributing to altered palatal morphology. Until today, anatomical features of the newborn's palate are subject to a non-uniform nomenclature. CONCLUSION: Today's knowledge of a newborn's 'normal' palatal morphology is based on non-standardized and limited methodologies for measuring a three-dimensional shape. This shortcoming increases bias and is the reason for contradictory research results, especially if pathologic conditions like syndromes or prematurity are involved. Adequate measurement techniques are needed and the 'normal palatal morphology' should be defined prior to new clinical studies on palatal development.

Project description:BackgroundNeonatal acute respiratory distress syndrome (ARDS) is a critical clinical disease with high disability and mortality rates. Early identification and treatment of neonatal ARDS is critical. This study aimed to build a perinatal prediction nomogram for early prediction of neonatal ARDS.MethodsA prediction model was built including 243 late-preterm and full-term infants from Daping Hospital in Chongqing, China, hospitalised between Jan 1, 2018 and Dec 31, 2019. 80 patients from the Children's Hospital in Chongqing, China, hospitalised between Jan 1, 2018 and June 30, 2018 were considered for external validation. Multivariate logistic regression was performed to identify independent predictors and establish a nomogram to predict the occurrence of neonatal ARDS. Both discrimination and calibration were assessed by bootstrapping with 1000 resamples.FindingsMultivariate logistic regression demonstrated that mother's education level (odds ratio [OR] 0·478, 95% confidence interval [CI] 0·324-0·704), premature rupture of membrane (OR 0·296, 95% CI 0·133-0·655), infectious disease within 7 days before delivery (OR 0·275, 95% CI 0·083-0·909), hospital level (OR 2·479, 95% CI 1·260-4·877), and Apgar 5-min score (OR 0·717, 95% CI 0·563-0·913) were independent predictors for neonatal ARDS in late-preterm and full-term infants, who experienced dyspnoea within 24 h after birth and required mechanical ventilation. The area under the curve and concordance index of the nomogram constructed from the above five factors were 0·760 and 0·757, respectively. The Hosmer-Lemeshow test showed that the model was a good fit (P = 0.320). The calibration curve of the nomogram was close to the ideal diagonal line. Furthermore, the decision curve analysis demonstrated significantly better net benefit in the model. The external validation proved the reliability of the prediction nomogram.InterpretationA nomogram based on perinatal factors was developed to predict the occurrence of neonatal ARDS in late-preterm and full-term infants who experienced dyspnoea within 24 h after birth and required mechanical ventilation. It provided clinicians with an accurate and effective tool for the early prediction and timely management of neonatal ARDS.FundingNo funding was associated with this study.

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Barriers to enrollment in a randomized controlled trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants.

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Barriers to enrollment in a randomized controlled trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants.

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