Influence of prior assignment on refusal rates in a trial of supplemental oxygen for retinopathy of prematurity

2006 ◽  
Vol 20 (4) ◽  
pp. 348-359 ◽  
Author(s):  
Rolf R. Engel ◽  
Neal L. Oden ◽  
Geoff R. Cohen ◽  
Dale L. Phelps ◽  
2016 ◽  
Vol 45 (6) ◽  
pp. 270
Author(s):  
Rinawati Rohsiswatmo

Background Retinopathy of prematurity (ROP) is one of the ma-jor causes of infant blindness. There are several factors known asrisk factors for ROP. Recent studies show ROP as a disease ofmultifactorial origin.Objective To report the prevalence of ROP in Cipto MangunkusumoHospital, Jakarta and its relation to several risk factors.Methods A cross-sectional descriptive study was conducted fromDecember 2003-May 2005. All infants with birth weight 2500 gramsor less, or gestational age 37 weeks or less, were enrolled con-secutively and underwent the screening of ROP at 4 to 6 weeks ofchronological age or 31 to 33 weeks of postconceptional age.Result Of 73 infant who met the inclusion criteria, 26% (19 out of73 infant) had ROP in various degrees. About 36.8% (7 out of 19infants) were in stage III or more/threshold ROP. No ROP wasnoted in infants born >35 weeks of gestational age, and birth weight>2100 grams. No severe ROP was found in gestational age >34weeks and birth weight >1600 grams. None of full-term, small forgestational age infants experienced ROP. Birth weight, sepsis,apneu, asphyxia, multiple blood transfusions, and oxygen therapyfor more than 7 days were statistically significant with the develop-ment of ROP. However, using multivariate analysis, only asphyxia,multiple blood transfusions, and oxygen therapy for more than 7days were statistically significant with the development of ROP.Conclusion Screening of ROP should be performed in infantsborn 34 weeks of gestational age and/or birth weight <1600 grams.Infants with birth weight from 1600-<2100 grams need to bescreened only if supplemental oxygen is necessary or with clini-cally severe illness


Retina ◽  
1993 ◽  
Vol 13 (3) ◽  
pp. 222-229 ◽  
Author(s):  
JEFFREY D. BENNER ◽  
LAWRENCE S. MORSE ◽  
ANDY HAY ◽  
MAURICE B. LANDERS

2017 ◽  
Vol 58 (2) ◽  
pp. 887 ◽  
Author(s):  
Tarah T. Colaizy ◽  
Susannah Longmuir ◽  
Kevin Gertsch ◽  
Michael David Abràmoff ◽  
Jonathan M. Klein

2020 ◽  
Vol 3 ◽  
Author(s):  
Robert Minturn ◽  
Mary Beth Koch ◽  
Emily Anderson ◽  
Kok Lim Kua ◽  
Kathryn Haider

Background/Objective:  Retinopathy of Prematurity (ROP) is a leading causes of childhood blindness.  It affects 15,000 surviving US preterm infants annually, with 1,400 infants developing severe ROP and 500 infants developing legal blindness.  The pathogenesis of ROP involves 2 phases: During phase 1, the immature retinal vascularization is obliterated due to hyperoxia. During phase 2 (>4 weeks postnatally), abnormal neovascularization occurs due to hypoxia, sometimes requiring surgical intervention.   We retrospectively evaluated the impact of late supplemental oxygen (>4 weeks postnatally) on ROP progression in infants born <28 weeks.   Methods:  Preterm infants <28 weeks with >stage 2 ROP admitted to the Riley Hospital for Children Neonatal Intensive Care Unit (NICU) from 7/2017- 12/2019 were included. Nine patients treated with supplemental oxygen therapy were compared to a control cohort managed by a standard protocol after the diagnosis of stage 2 ROP.  The primary outcome was the need for surgical intervention with either laser or bevacizumab treatment. Continuous data was analyzed using unpaired t-test, and categorical data was analyzed using fishers exact test.   Results:  There was no statistical difference in regard to clinical variables contributing to risk of severe ROP (sex, race, birthweight necrotizing enterocolitis, bronchopulmonary dysplasia or length of stay) between the two study cohorts. There was a statistically significant decrease in need for treatments (laser or bevacizumab) in patients receiving supplemental oxygen (control: 35/83 patients treated, late O2: 0/9 patients treated, p=0.012).   Conclusion and Implications:  Supplemental oxygen therapy seems to have a protective effect on the development of treatable ROP (type I).  Limiting surgical intervention (laser or bevacizumab) would directly benefit the babies by decreasing the need for sedation and any inherent risks of surgery. This initial data suggests the need for future studies with a higher sample size to validate the efficacy of late supplemental O2 in ROP.       Study Group  Control       Number (Mean)  % (SD)  Number (Mean)  % (SD)  p-value  Population (N)  9  -  83  -     Sex              Male  2  22.2%  35  42.2%  N.S.  Female  7  77.8%  48  57.8%  N.S.  Race              Caucasian  5  55.6%  44  53.0%  N.S.  Non-Caucasian  4  44.4%  39  47.0%  N.S.  Birthweight (grams)  698  145.26  721  197.09  N.S.  Gestational Age (Weeks)  24.94  1.19  25.32  1.72  N.S.  Length of Stay (Days)  129.22  27.13  148.58  67.97  N.S.  Necrotizing Enterocolitis              Yes  3  33.3%  21  25.3%  N.S.  No  6  66.7%  62  74.7%  N.S.  Sepsis              Yes  6  66.7%  41  49.4%  N.S.  No  3  33.3%  42  50.6%  N.S.  Bronchopulmonary Dysplasia              Yes  9  100.0%  80  96.4%  N.S.  No  0  0.0%  2  2.4%  N.S.  Need for Additional Treatment (Inpatient)              Yes  0  0.0%  35  42.2%  N.S.  No  9  100.0%  48  57.8%  N.S.  Need for Additional Treatment (Outpatient)              Yes  0  0.0%  35  42.2%  0.012  No  9  100.0%  48  57.8%    


Author(s):  
Alan D. Penman ◽  
Kimberly W. Crowder ◽  
William M. Watkins

The Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP) study was a randomized, controlled clinical trial to determine whether the use of supplemental therapeutic oxygen in premature infants reduced the probability of progression from prethreshold to threshold ROP and the need for peripheral retinal ablation. The study found that supplemental oxygen at pulse oximetry saturations of 96% to 99% did not cause additional progression of prethreshold ROP but also did not significantly reduce the number of infants requiring peripheral ablative surgery. However, the risk of adverse pulmonary events was increased.


Author(s):  
Hany Aly ◽  
Hasan F. Othman ◽  
Chelsea Munster ◽  
Anirudha Das ◽  
Jonathan Sears

Objective The use of supplemental oxygen in premature infants is essential for survival. However, its use has been associated with unintended complications. The restricted use of oxygen is associated with increased mortality and necrotizing enterocolitis (NEC), whereas its liberal use is associated with increased risk for retinopathy of prematurity (ROP). Although there is no clear consensus on the acceptable oxygen saturation range, clinicians have recently become more liberal with the use of oxygen. We aim to assess (1) the national trends for ROP in very low birth weight preterm infants, and (2) the associated trends in mortality, NEC, intraventricular hemorrhage (IVH), and length of hospital stay (LOS). Methods We analyzed deidentified patient data from the National Inpatient Sample (NIS) of the Healthcare Cost and Utilization Project (HCUP) from 2002 to 2017. All infants with gestational age ≤32 weeks and birth weight <1500 g were included. Trends in ROP, severe ROP, mortality, NEC, IVH, severe IVH, and LOS were analyzed using Jonckheere-Terpstra test. Results A total of 818,945 neonates were included in the study. The overall mortality was 16.2% and the prevalence of ROP was 17.5%. There was a significant trend for increased ROP over the years (p < 0.001). Severe ROP was also significantly increased (p < 0.001). This was associated with a significant trend for increased median LOS in survived infants (p < 0.001). Mortality was significantly decreased (p < 0.001), whereas NEC and severe NEC did not change over time (p = 0.222 and p = 0.412, respectively). Conclusion There is a national trend for increased ROP and severe ROP over the 16 years of the study period. This trend was associated with a significant increase in the LOS in survived infants without change in NEC. Key Points


Author(s):  
Ramamani Dalai ◽  
Kedarnath Das ◽  
Diptimayee Nayak ◽  
Mangal Charan Murmu ◽  
Prasanta Kumar Nanda

Background: Retinopathy of prematurity (ROP) is a multifactorial vasoproliferative retinal disorder that increases in incidence with decreasing gestational age. India shares 20% of the world childhood blindness. Besides congenital cataract, congenital glaucoma and ocular injuries, ROP is emerging as one of the important causes of childhood blindness in India.Methods: This hospital based prospective study was undertaken during October 2016 to September 2018 in the Department of Ophthalmology, SCB Medical College. Authors included (a) all preterm infants weighing less than 1750gm or gestational age less than 34 weeks at birth, (b) infants with birth weight between 1750gm to 2000gm and gestational age more than 34 weeks (late preterm and term infants) those were considered as high risk.Results: Among the 328 babies included in our study, the incidence of ROP was 29.57%. Bilateral ROP was found in 76.29% with nearly equal stages in both eyes and only 23 neonates showed unilateral involvement.Conclusions: Low birth weight, lower gestational age, blood transfusion, Respiratory Distress Syndrome (RDS), apnoea, supplemental oxygen therapy, maternal anaemia and gestational diabetes mellitus (GDM) were strongly associated with development of ROP.


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