Efficacy of water-based vitamin E solution versus placebo in the prevention of retinopathy of prematurity in very low birth weight infants: A randomized clinical trial.
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SUBMITTER: Romero-Maldonado S
PROVIDER: S-EPMC8341298 | biostudies-literature | 2021 Aug
REPOSITORIES: biostudies-literature
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Efficacy of water-based vitamin E solution versus placebo in the prevention of retinopathy of prematurity in very low birth weight infants: A randomized clinical trial.
Romero-Maldonado Silvia S Montoya-Estrada Araceli A Reyes-Muñoz Enrique E Guzmán-Grenfell Alberto Martín AM Torres-Ramos Yessica Dorin YD Sánchez-Mendez Mario David MD Tolentino-Dolores Maricruz M Salgado-Valladares Manuel Bernardo MB Belmont-Gómez Aurora A Najéra Nayelli N Ceballos Guillermo G Cardona-Pérez Jorge Arturo JA Hicks Juan José JJ Mancilla-Ramírez Javier J
Medicine 20210801 31
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Project description:Preeclampsia and retinopathy of prematurity (ROP) are associated with impaired angiogenesis. Previous studies on the relationship between preeclampsia and ROP have produced conflicting results. The goal of this study was to evaluate the association between maternal preeclampsia and ROP using a large population-based cohort of very-low-birth-weight (VLBW) infants from 21 neonatal departments registered in the database of the Premature Baby Foundation of Taiwan. Multivariable logistic regression analysis was used to estimate the adjusted odds ratios (OR) and 95% confidence intervals (CI) for preeclampsia with reference to ROP and severe ROP. A total of 5,718 VLBW infants (844 cases with maternal preeclampsia) were included for analysis. The overall incidences of mild and severe ROP were 36.0% and 12.2%, respectively. Univariable analysis showed lower GA and lower birth weight, vaginal delivery, non-SGA, RDS, PDA, sepsis, transfusion, and absence of maternal preeclampsia to be associated with mild and severe ROP development. However, OR (95% CI) adjusted for the variables that were significant according to univariable analysis showed the risks of developing any-stage ROP and severe ROP for maternal preeclampsia to be 1.00 (0.84-1.20) and 0.89 (0.63-1.25), respectively. The results remained unchanged in stratified analyses according to SGA status. Our data showed that maternal preeclampsia was not associated with the subsequent development of any stage or severe ROP in VLBW infants.
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Project description:To investigate hearing impairment and its association with retinopathy of prematurity (ROP) among children born with very low birth weight (VLBW, birth weight < 1500 g). This prospective registry study included 7940 VLBW infants who underwent both ophthalmic (ROP) and hearing screening at the 70 participating centers of the Korean Neonatal Network. Hearing screening was performed using auditory brainstem response and/or automated otoacoustic emission testing. Hearing impairment, defined as a unilateral or bilateral hearing threshold of ≥40 dB on the auditory brainstem response threshold (ABR-T) test, was evaluated and compared between children with and without ROP at the corrected ages of 18 months and 3 years. The frequency of infants who did not undergo hearing screening at near-term ages was higher in the ROP group than in the no-ROP group (18.2% vs. 12.0%, p < 0.001), and the prevalence of hearing impairment at 18 months was higher in the ROP group than in the no-ROP group (3.5% vs. 2.2%, p = 0.043). The prevalence of deafness was higher in children with ROP than those without ROP (0.4% vs. 0.1%, p = 0.049). There were significant differences in hearing impairment among the stages of ROP (p < 0.001). However, multivariate analyses and propensity score matching showed no significant association between ROP and hearing impairment at 18 months and 3 years after adjusting for prematurity-related variables (all p > 0.05). Among infants born with VLBW, hearing impairment was more common in those with ROP than in those without ROP at 18 months of age. However, there was no significant independent association between hearing impairment and ROP.
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Project description:PurposeTo determine genetic variants associated with severe retinopathy of prematurity (ROP) in a candidate gene cohort study of US preterm infants.MethodsPreterm infants in the discovery cohort were enrolled through the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network, and those in the replication cohort were from the University of Iowa. All infants were phenotyped for ROP severity. Because of differences in the durations of enrollment between cohorts, severe ROP was defined as threshold disease in the discovery cohort and as threshold disease or type 1 ROP in the replication cohort. Whole genome amplified DNA from stored blood spot samples from the Neonatal Research Network biorepository was genotyped using an Illumina GoldenGate platform for candidate gene single nucleotide polymorphisms (SNPs) involving angiogenic, developmental, inflammatory, and oxidative pathways. Three analyses were performed to determine significant epidemiologic variables and SNPs associated with levels of ROP severity. Analyses controlled for multiple comparisons, ancestral eigenvalues, family relatedness, and significant epidemiologic variables. Single nucleotide polymorphisms significantly associated with ROP severity from the discovery cohort were analyzed in the replication cohort and in meta-analysis.ResultsEight hundred seventeen infants in the discovery cohort and 543 in the replication cohort were analyzed. Severe ROP occurred in 126 infants in the discovery and in 14 in the replication cohort. In both cohorts, ventilation days and seizure occurrence were associated with severe ROP. After controlling for significant factors and multiple comparisons, two intronic SNPs in the gene BDNF (rs7934165 and rs2049046, P < 3.1 × 10(-5)) were associated with severe ROP in the discovery cohort and were not associated with severe ROP in the replication cohort. However, when the cohorts were analyzed together in an exploratory meta-analysis, rs7934165 increased in associated significance with severe ROP (P = 2.9 × 10(-7)).ConclusionsVariants in BDNF encoding brain-derived neurotrophic factor were associated with severe ROP in a large candidate gene study of infants with threshold ROP.
| S-EPMC4188045 | biostudies-literature
Project description:ObjectiveTo predict retinopathy of prematurity (ROP) exam findings among infants with birth weight <1251 g from 32-40 weeks postmenstrual age (PMA).Study designSecondary analysis of 3714 eye exams from 1239 infants.ResultsThe likelihood of developing type 1 ROP by 40 weeks PMA varied by gestational age (GA) (P < .001), from 33% for ≤25 weeks, 10% for 26 or 27 weeks, 4% for 28 or 29 weeks, and none for ≥30 weeks. By 40 weeks PMA, 51% with GA ≤27 weeks still needed subsequent exams. Previous exam findings, GA, and PMA were predictive of the development of type 1 ROP (area under the curve, 0.78) or mature retina (area under the curve, 0.85).ConclusionsThis analysis provides the opportunity for development of an ROP approach to estimate resource needs in the neonatal intensive care unit and to facilitate communication with families when planning discharge or transfer.
| S-EPMC4308554 | biostudies-literature
Project description:BackgroundThe aim of the study was to determine the rate of cytomegalovirus virolactia in the human milk (HM) of mothers of VLBW infants, compare the CMV infection rates and the changes in CMV DNA viral load and nutrient profile among different HM preparation methods.MethodsA prospective randomized controlled study was performed in infants with gestational age < 32 weeks or birth-weight < 1500 g admitted to neonatal intensive care unit of Asan Medical Center and Haeundae Paik Hospital who were given mother's own milk. Enrolled infants were randomized into three groups according to the HM preparation methods: freezing-thawing (FT), FT + low-temperature Holder pasteurization (FT + LP), and FT + high-temperature short-term pasteurization (FT + HP). Urine CMV culture and PCR were obtained at birth and at 4, 8, and 12 weeks. HM CMV culture and PCR were obtained at birth and at 3, 6, 9, and 12 weeks. Changes in macronutrients in HM was obtained at 4 ~ 6 weeks.ResultsOf 564 infants, 217 mothers (38.5%) produced CMV PCR positive milk. After exclusion, a total of 125 infants were randomized into the FT (n = 41), FT + LP (n = 42), and FT + HP (n = 42) groups, whose rate of HM-acquired CMV infection was 4.9% (n = 2), 9.5% (n = 4), and 2.4% (n = 1), respectively. Out of seven CMV infected infants, two infants fed with FT + LP HM developed CMV infection- associated symptoms. Ages at diagnoses were earlier (28.5 days after birth) and at younger post conceptional age (< 32 weeks) in comparison to infants with asymptomatic CMV infection. CMV DNA viral load significantly decreased after pasturizations, especially in FT + HP group.ConclusionsHM-acquired symptomatic CMV infection rate is low and its impact on clinical course was not serious in our VLBW infants. However, evidences showing poor neurodevelopmental outcome in later life, we need to generate a guideline to protect VLBW infant form HM transmitted CMV infection. Based on our small sized study, we did not find any superiority in pasteurizing HM with frequently used LP in comparison to frozen or HP HM. More research is needed to determine the method and duration of pasteurization to reduce the HM-acquired CMV infection.
| S-EPMC10193732 | biostudies-literature
Project description:Bacterial sepsis is associated with high morbidity and mortality in preterm infants. However, diagnosis of sepsis and identification of the causative agent remains challenging. Our aim was to determine genome-wide expression profiles of very low birth weight (VLBW) infants with and without bacterial sepsis and assess differences.
2016-05-29 | E-MTAB-4785 | biostudies-arrayexpress
Project description:BackgroundThe causative factors responsible for the development of Retinopathy of Prematurity (ROP) are still unexplored. Therefore, one of the most important factors can be perinatal inflammation.MethodsThis retrospective study included 114 premature infants (228 eyes) meeting a birth criteria of ≤ 32 weeks gestational age (GA) and a birth weight (BW) ≤ 1710. Examined Group (EG) n = 51 of BW 852.7 ± 255.7; GA 26.3 ± 2.0 with severe ROP treated by diode laser or anti-VEGF intravitreal injection. Control Group (CG) n = 63 of BW 1313.9 ± 284.5; GA 28.8 ± 1.6 without ROP. Microbiological bacterial and fungal cultures of the ear, anus, bronchial throat and blood were taken. Medical data and laboratory tests in correlation to 3 ROP and A-ROP were analysed.ResultsPositive bacterial tests dominated in EG, 47% vs. CG, 23%. Significant correlations between positive cultures obtained from natural cavities: anus (p < 0.001), throat (p = 0.002), as well as from blood (p = 0.001) and severe ROP which requires diode laser and anti-VEGF treatment were noted. Significant inflammation markers which correlate with the development of severe ROP are Klebsiella pneumoniae (KP) (p = 0.002) and Coagulase-negative Staphylococci (CoNS) (p < 0.001). CoNS, p < 0.001; KP, p = 0.002; the remaining Maltophilia stenotrophomonas (MS); Staphylococcus aureus (SA), p = 0.005; and Enterobacter cloacae (EC), p = 0.02 were the most frequent bacteria in severe ROP. High levels of white blood cells (WBC), C-reactive protein (CRP), lymphocytes (LYM) and low thrombocytes (PLT) correlated sequentially with (Odds Ratio, OR) CoNS (2.3); MS (5.9); KP (3.1); and all positive cultures (APC) (9.5). An important correlation between the BPD-EC (4.3); intrauterine inflammation-KP (3.4); PDA-EC (3.9); and asphyxia-CoNS (3.0) was identified.ConclusionsIt cannot be ruled out that positive microbiological results of blood, anal and pharyngeal cultures may become prognostic markers for the early development of ROP, which would enable early initiation of ophthalmological treatment in premature infants from the VLBW group.
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Project description:To determine the association between direct costs for the initial neonatal intensive care unit hospitalization and 4 potentially preventable morbidities in a retrospective cohort of very low birth weight (VLBW) infants (birth weight <1500 g).The sample included 425 VLBW infants born alive between July 2005 and June 2009 at Rush University Medical Center. Morbidities included brain injury, necrotizing enterocolitis, bronchopulmonary dysplasia, and late-onset sepsis. Clinical and economic data were retrieved from the institution's system-wide data and cost accounting system. A general linear regression model was fit to determine incremental direct costs associated with each morbidity.After controlling for birth weight, gestational age, and sociodemographic characteristics, the presence of brain injury was associated with a $12048 (P = .005) increase in direct costs; necrotizing enterocolitis, with a $15 440 (P = .005) increase; bronchopulmonary dysplasia, with a $31565 (P < .001) increase; and late-onset sepsis, with a $10055 (P < .001) increase. The absolute number of morbidities was also associated with significantly higher costs.This study provides collective estimates of the direct costs incurred during neonatal intensive care unit hospitalization for these 4 morbidities in VLBW infants. The incremental costs associated with these morbidities are high, and these data can inform future studies evaluating interventions aimed at preventing or reducing these costly morbidities.
| S-EPMC3584449 | biostudies-other
Project description:ImportanceThrombocytopenia and intraventricular hemorrhage (IVH) are common among very-low-birth-weight (VLBW) infants. Survey results suggest that US neonatologists frequently administer platelet transfusions to VLBW infants with mild to moderate thrombocytopenia.ObjectivesTo characterize platelet transfusion practices in US neonatal intensive care units (NICUs), to determine whether severity of illness influences platelet transfusion decisions, and to examine the association between platelet count (PCT) and the risk for IVH in the first 7 days of life.Design, setting, and participantsThis multicenter, retrospective cohort study included 972 VLBW infants treated in 6 US NICUs, with admission dates from January 1, 2006, to December 31, 2007. Data were collected from all infants until NICU discharge or death (last day of data collected, December 4, 2008). Data were entered into the central database, cleaned, and analyzed from May 1, 2009, to February 11, 2016.InterventionPlatelet transfusion.Main outcomes and measuresNumber of platelet transfusions and incidence of IVH.ResultsAmong the 972 VLBW infants (520 [53.5%] male; mean [SD] gestational age, 28.2 [2.9] weeks), 231 received 1002 platelet transfusions (mean [SD], 4.3 [6.0] per infant; range, 1-63 per infant). The pretransfusion PCT was at least 50 000/μL for 653 of 998 transfusions (65.4%) with this information. Two hundred eighty-one transfusions (28.0%) were given during the first 7 days of life. During that period, platelet transfusions were given on 35 of 53 days (66.0%) when the patient had a PCT less than 50 000/μL and on 203 of 436 days (46.6%) when the patient had a PCT of 50 000/μL to 99 000/μL. At least 1 marker of severe illness was present on 198 of 212 patient-days (93.4%) with thrombocytopenia (PCT, <100 000/μL) when a platelet transfusion was given compared with 113 of 190 patient-days (59.5%) with thrombocytopenia when no platelet transfusion was given. Thrombocytopenia was a risk factor for intraventricular hemorrhage during the first 7 days of life (hazard ratio, 2.17; 95% CI, 1.53-3.08; P < .001). However, no correlation was found between severity of thrombocytopenia and risk for IVH. After controlling for significant clinical factors and thrombocytopenia, platelet transfusions did not have a significant effect on the incidence of IVH (hazard ratio, 0.92; 95% CI, 0.49-1.73; P = .80).Conclusions and relevanceA large proportion of platelet transfusions were given to VLBW infants with PCT greater than 50 000/μL. Severity of illness influenced transfusion decisions. However, the severity of thrombocytopenia did not correlate with the risk for IVH, and platelet transfusions did not reduce this risk.
| S-EPMC6377279 | biostudies-literature
Project description:BackgroundVitamin A plays an important role in the development and maintenance of the normal function of organs and systems. Premature infants have low levels of vitamin A, which may be associated with an increased risk of developing disease. This study aimed to evaluate the effects of vitamin A supplementation on short-term morbidity and mortality in very-low-birth-weight (VLBW) infants.MethodsWe used PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, and Web of Science to conduct a literature search of studies published before January 1, 2022, to be included in our meta-analysis. The analysis included randomized controlled trials that compared the effects of vitamin A supplementation on VLBW infants (birth weight <1,500 g) and controls given a placebo or no treatment. The certainty of evidence was assessed using Grading of Recommendations, Assessment, Development and Evaluation (GRADE) guidelines.ResultsTwelve randomized controlled trials were included in the meta-analysis, and 2,111 infants were pooled and analyzed. The overall risk of bias was not serious in the included studies. Vitamin A supplementation for reducing the incidence of bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age seems to be limited [risk ratio (RR):0.85; 95% confidence intervals (CI): 0.70-1.04; 8 studies, 1,595 infants, very-low-certainty evidence], which is different from the previous systematic review. Length of hospital stay (mean difference: -12.67, 95% CI: -23.55 to -1.79; 6 studies, 739 infants, low-certainty evidence), and the incidence of vitamin A deficiency at 28 days postnatal age (RR: 0.08; 95% CI: 0.02-0.38; 3 studies, 358 infants, low-certainty evidence) were reduced in the vitamin A group. Besides, vitamin A supplementation seems to reduce the incidence of periventricular leukomalacia (RR: 0.68; 95% CI: 0.47-0.97; 4 studies, 1,224 infants, low-certainty evidence) and retinopathy of prematurity of any grade (RR: 0.61; 95% CI: 0.48-0.76; 4 studies, 463 infants, moderate-certainty evidence).ConclusionsThere is no sufficient evidence regarding vitamin A supplementation preventing BPD in VLBW infants. Vitamin A supplementation can reduce the incidence of vitamin A deficiency and retinopathy of prematurity of any grade, and may exert an effect of preventing periventricular leukomalacia.Systematic review registrationhttp://www.crd.york.ac.uk/PROSPERO/, identifier: CRD42020211070.
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