scholarly journals ‘NOPAIN-ROP’ trial: Intravenous fentanyl and intravenous ketamine for pain relief during laser photocoagulation for retinopathy of prematurity (ROP) in preterm infants: A randomised trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e046235
Author(s):  
Shamnad Madathil ◽  
Deena Thomas ◽  
Parijat Chandra ◽  
Ramesh Agarwal ◽  
M Jeeva Sankar ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Retinopathy Of Prematurity ◽  
Laser Photocoagulation ◽  
Bolus Dose ◽  
Tertiary Care ◽  
Randomised Trial ◽  
Haemodynamic Instability ◽  
Intravenous Bolus ◽  
Intravenous Fentanyl ◽  
Intravenous Ketamine

ObjectivesTo investigate if intravenous fentanyl or intravenous ketamine can provide adequate analgesia in preterm infants undergoing laser photocoagulation for retinopathy of prematurity (ROP).DesignOpen-label randomised trial.SettingTertiary care institution.ParticipantsPreterm infants who underwent laser photocoagulation for ROP.InterventionsInfants were randomised to receive fentanyl as intravenous bolus dose of 2 µg/kg, followed by an intravenous infusion of 1 µg/kg/hour increased to a maximum of 3 µg/kg/hour or intravenous ketamine as bolus dose of 0.5 mg/kg, followed by further intermittent intravenous bolus doses of 0.5 mg/kg to a maximum of 2 mg/kg in the initial phase and intravenous fentanyl (bolus of 2 µg/kg followed by infusion of 2 µg/kg/hour to a maximum of 5 µg/kg/hour) or intravenous ketamine (bolus dose of 1 mg/kg followed by intermittent bolus doses of 0.5 mg/kg to a maximum of 4 mg/kg) in the revised regimen phase.Main outcome measuresProportion of infants with adequate analgesia defined as the presence of both: (1) all the Premature Infant Pain Profile-Revised scores measured every 15 min less than seven and (2) proportion of the procedure time the infant spent crying less than 5%.Secondary outcomes included apnoea, cardiorespiratory or haemodynamic instability, feed intolerance and urinary retention requiring catheterisation during and within 24 hours following the procedure.ResultsA total of 97 infants were randomised (fentanyl=51, ketamine=46). The proportions of infants with adequate analgesia were 16.3% (95% CI 8.5% to 29%) with fentanyl and 4.5% (95% CI 1.3% to 15.1%) with ketamine. Ten infants (19.6%) in the fentanyl group and seven infants (15.2%) in the ketamine group had one or more side effects. In view of inadequate analgesia with both the regimens, the study steering committee recommended using a higher dose of intravenous fentanyl and intravenous ketamine. Consequently, we enrolled 27 infants (fentanyl=13, ketamine=14). With revised regimens, the proportions of infants with adequate analgesia were higher: 23.1% (95% CI 8.2% to 50.2%) with fentanyl and 7.1% (95% CI 1.3% to 31.5%) with ketamine. However, higher proportions of infants developed apnoea (n=4; 30.7%), need for supplemental oxygen (n=5, 38.4%) and change in cardiorespiratory scores (n=7; 53.8%) with fentanyl but none with ketamine.ConclusionsFentanyl-based and ketamine-based drug regimens provided adequate analgesia only in a minority of infants undergoing laser photocoagulation for ROP. More research is needed to find safe and effective regimens that can be employed in resource constrained settings.Trial registration numberCTRI/2018/03/012878.

scholarly journals THE PREVALENCE OF RETINOPATHY OF PREMATURITY UNDER THE CONDITIONS OF THE PERINATAL CENTER BASED AT THE CHILDREN’S MULTI-DISCIPLINARY HOSPITAL

2017 ◽  
Vol 12 (2) ◽  
pp. 97-101
Author(s):  
Nataliya Nikolaevna Sadovnikova ◽  
N. V Prisich ◽  
V. V Brzheskiy ◽  
O. S Olina ◽  
A. G Li ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Preterm Infants ◽  
Retinopathy Of Prematurity ◽  
Laser Photocoagulation ◽  
Maternity Hospital ◽  
Extremely Low Birth Weight ◽  
Comprehensive Treatment ◽  
Average Weight ◽  
Number Of Children ◽  
Perinatal Center

Introduction. Retinopathy of prematurity remains one of the most challenging problems in neonatal ophthalmology and the leading cause of blindness and disability in the young children. Purpose. The objective of the present study was to evaluate the prevalence of retinopathy of prematurity and the effectiveness of its treatment under the present conditions of nursing the preterm infants. Materials and methods. We carried out the ophthalmological observations and treatment of 393 premature children admitted to the Perinatal Centre of the Saint Petersburg State Pediatric Medical University during the period from 2014 to 2016 for the provision of the specialized care needed to manage various obstetric and perinatal pathological conditions. The patients included the children born with a body weight from 450 to 2500 g (average weight of 1056 ± 301,9 g) at the 23d to 33d weeks of gestation (mean age at birth 28,77 ± 2,37 weeks). Results. The frequency of retinopathy of prematurity and dynamics of its clinical course as well as the need for its laser and surgical treatment in such patients differed during these three years. The number of children with retinopathy of prematurity in the group with the extremely low birth weight increased from 75.0% in 2014 to 96.3% in 2016 largely due to the rise in the occurrence of the early stages of the disease among the preterm infants in combination with severe concomitant cardiosurgical and neurosurgical pathologies. 77.8% of the children in this group needed to be treated with the use of preventive retinal laser photocoagulation. However, only every third infant born at the 28-33d week of gestation actually received the required surgical treatment. The effectiveness of retinal laser photocoagulation increased from 85% in 2014 to 95% in 2016. Conclusion. The management of the preterm children presenting with retinopathy of prematurity based at the perinatal centre with the integrated maternity hospital and the multidisciplinary children’s hospital creates the optimal conditions for the comprehensive treatment of such patients

scholarly journals Prevalence and outcome of retinopathy of prematurity in preterm infants, with low birth weight at KMCH, Tamil Nadu, India

2019 ◽  
Vol 6 (2) ◽  
pp. 264
Author(s):  
R. Nikhil ◽  
K. Rajendran ◽  
Bala Krishnan
Keyword(s):  
Birth Weight ◽  
Low Birth Weight ◽  
Preterm Infants ◽  
Gestational Age ◽  
Retinopathy Of Prematurity ◽  
Tamil Nadu ◽  
Tertiary Care ◽  
Inclusion Criteria ◽  
Very High

Background: Premature infants have avascular or incompletely vascularized retina at birth and ROP evolves over 4-5 weeks after birth. The aim of this study is to know the prevalence of retinopathy of prematurity in preterm infants, with birth weight ≤ 1500 grams and/or gestational age ≤32 weeks in a tertiary care center.Methods: The study was conducted in Kovai Medical Centre and Hospital Coimbatore in 2016. The sample size is 95 babies. All preterm infants admitted with a birth weight of ≤1500 grams and/or ≤ 32 weeks of gestation and baby those at risk of ROP.Results: 95 babies have enrolled during the study period of which 78 babies fulfilled the inclusion criteria and completed this prospective study.12 babies could not complete the follow-up protocol and 5 babies died before full vascularization of the retina. 78 babies who fulfilled the inclusion criteria were screened and 15 babies were found to have ROP. The prevalence of ROP in this study is 19.2%.Conclusions: Among the preventable causes of blindness in children, ROP figures very high on the agenda. Low birth weight and gestational age were found to be the most important risk factors for the development of ROP.

scholarly journals Assessment of Outcomes With a Sedation Protocol During Laser Photocoagulation in Preterm Infants With Retinopathy of Prematurity

2018 ◽  
Vol 23 (5) ◽  
pp. 410-416 ◽  
Author(s):  
Jennifer F. Dannelley ◽  
Peter N. Johnson ◽  
Michael P. Anderson ◽  
Kari Oestreich ◽  
R. Michael Siatkowski ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Retrospective Study ◽  
Adverse Events ◽  
Clinical Response ◽  
Preterm Infants ◽  
Retinopathy Of Prematurity ◽  
Laser Photocoagulation ◽  
Primary Objective ◽  
Sedation Protocol ◽  
Midazolam Infusion

OBJECTIVES To evaluate the success of a sedation protocol of fentanyl and midazolam infusions for infants undergoing laser photocoagulation for retinopathy of prematurity. METHODS This retrospective study included infants receiving a sedation protocol for laser photocoagulation during a 4-year period. The primary objective was protocol success, defined as completion without interruption, absence of protocol dose deviations, and absence of interventions. Secondary objectives compared outcomes between those with and without opioid/benzodiazepine exposure. A logistic regression was used to assess the effect of prior opioid/benzodiazepine exposure on requirement for fentanyl infusion increases. RESULTS Twenty-six infants were included. Seven (26.9%) had protocol success. Sixteen (61.5%) had protocol success, excluding dose deviations. Seventeen (65.4%) experienced ≥1 cardiopulmonary adverse events. Photocoagulation was completed in all cases. CONCLUSIONS Most achieved protocol success, when eliminating dosing deviations. These data indicate that flexibility is needed in fentanyl and midazolam infusion titration, based on clinical response.

scholarly journals TO STUDY THE PREVALENCE OF RETINOPATHY OF PREMATURITY IN PRETERM INFANTS: AN HOSPITAL BASED OBSERVATIONAL STUDY.

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Binit Singh ◽  
Rizwan Haider ◽  
Ved Prakash Gupta
Keyword(s):  
Birth Weight ◽  
Low Birth Weight ◽  
Preterm Infants ◽  
Gestational Age ◽  
Retinopathy Of Prematurity ◽  
Care Center ◽  
Tertiary Care ◽  
Tertiary Care Center ◽  
Inclusion Criteria

Background: Premature infants have avascular or incompletely vascularized retina at birth and ROP evolves over 4-5 weeks after birth. The aim of this study is to know the prevalence of retinopathy of prematurity in preterm infants, with birth weight ? 1500 grams and/or gestational age ?32 weeks in a tertiary care center. Material and methods: The study was conducted in a tertiary care center of Bihar region India The sample size is 145 babies. All preterm infants admitted with a birth weight of ?1500 grams and/or ? 32 weeks of gestation and baby those at risk of ROP. Results: 145 babies have enrolled during the study period of which 124 babies fulfilled the inclusion criteria and completed this prospective study.15 babies could not complete the follow-up protocol and 6 babies died before full vascularization of the retina. 124 babies who fulfilled the inclusion criteria were screened and 33 babies were found to have ROP. The prevalence of ROP in this study is 26.6%. Conclusions: Among the preventable causes of blindness in children, ROP figures very high on the agenda. Low birth weight and gestational age were found to be the most important risk factors for the development of ROP. Keywords: Low birth weight, Prematurity in preterm infant, Retinopathy, Oxygen therapy

scholarly journals Incidence and risk factors of retinopathy of prematurity in Goa, India: a report from tertiary care centre

2019 ◽  
Vol 6 (3) ◽  
pp. 1228
Author(s):  
Sarvesh Kossambe ◽  
Shilpa Joglekar ◽  
Annely D'lima ◽  
M. P. Silveira
Keyword(s):  
Risk Factors ◽  
Birth Weight ◽  
Retinopathy Of Prematurity ◽  
Neonatal Intensive Care ◽  
Laser Photocoagulation ◽  
Very Low Birth Weight ◽  
Care Center ◽  
Tertiary Care ◽  
Preterm Neonates ◽  
Tertiary Care Centre

Background: To report the incidence and risk factors leading to the development of retinopathy of prematurity (ROP) from a tertiary care center in the western Indian state of Goa, India.Methods: This was a prospective observational study carried out in a level II neonatal intensive care unit (NICU) for a period of 18 months. Babies born at < 34 weeks’ gestation and having a birth weight of <1500gm were screened for ROP and laser photocoagulation was done for those who developed threshold ROP. Group differences between any ROP and threshold ROP were analysed using the chi-square test.Results: Out of the 244 preterm neonates screened, 37 developed ROP (15.16%), and 14 out of them (5.73%) developed threshold ROP requiring laser photocoagulation. Very low birth weight, prematurity, apnea, anemia, sepsis, respiratory distress syndrome, bronchopulmonary dysplasia, blood transfusions, exchange transfusions and days taken to reach full enteral feeds and regain birth weight were significantly associated with the development of ROP.Conclusions: This is the first report of ROP from Goa where less than 1 in 5 babies developed ROP. This is similar to that reported across the rest of the country. Judicious oxygen use, ventilation strategies, transfusions guidelines, control of sepsis, early enteral feeds and adequate nutrition may help prevent the development of ROP in the future.

scholarly journals Validation of the WINROP screening algorithm among preterm infants in East Malaysia

2019 ◽  
Vol 16 (4) ◽  
pp. 250-259
Author(s):  
Nurhayati Abdul Kadir ◽  
Syed Shoeb Ahmad ◽  
Shuaibah Abdul Ghani ◽  
Mae-Lyn Catherine Bastion
Keyword(s):  
High Risk ◽  
Preterm Infants ◽  
Retinopathy Of Prematurity ◽  
Tertiary Care ◽  
Time Lag ◽  
Low Risk ◽  
Screening Algorithm ◽  
East Malaysia ◽  
Type 1 Rop

Objective: To prospectively validate the WINROP (Weight, Insulin-like growth factor 1, Neonatal, Retinopathy of Prematurity) screening algorithm (www.winrop.com) based on longitudinal measurements of neonatal body weights in predicting the development of severe retinopathy of prematurity (ROP) among preterm infants admitted to the neonatal intensive care unit of a tertiary care center in East Malaysia. Methods: All premature infants of less than 32 weeks gestational age (GA) were included in this cohort. Their body weight was measured weekly from birth to 36 weeks postmenstrual age and entered into the computer-based surveillance system: WINROP. Infants were then classified by the system into high- or low-risk alarm group. The retinopathy findings were recorded according to Early Treatment for ROP criteria. However, the screening and management of infants were done according to the recommendations of the Continuous Practice Guidelines, Ministry of Health, Malaysia. The team members involved in screening and those recording the findings were kept blinded from each other. Results: A total of 151 infants with median GA at birth of 30 weeks (interquartile range [IQR] Å} 2.1) and mean birth weight of 1,264 g (standard deviation Å} 271) were analyzed. High-risk alarm was signaled in 85 (56.3%) infants and 9 (6.6%) infants developed type 1 ROP. One infant in the low-risk alarm group developed type 1 ROP requiring laser retinal photocoagulation. The median time lag from the high-risk alarm signal to the development of type 1 ROP was 10.4 (IQR Å} 8.4) weeks. Conclusion: In this cohort, the WINROP algorithm had a sensitivity of 90%, with negative predictive value of 98.5% (95% confidence interval) for detecting infants with type 1 ROP and was able to predict infants with ROP earlier than their due screening date. This study shows that a modified version of the WINROP algorithm aimed at specific populations may improve the outcome of this technique.

scholarly journals Identification of candidate genes and pathways in retinopathy of prematurity by whole exome sequencing of preterm infants enriched in phenotypic extremes

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Sang Jin Kim ◽  
◽  
Kemal Sonmez ◽  
Ryan Swan ◽  
J. Peter Campbell ◽  
...  
Keyword(s):  
Exome Sequencing ◽  
Whole Exome Sequencing ◽  
Preterm Infants ◽  
Premature Infants ◽  
Retinopathy Of Prematurity ◽  
Smooth Endoplasmic Reticulum ◽  
Enrichment Analysis ◽  
Retinal Disease ◽  
Gene Set Enrichment Analysis ◽  
Whole Exome

AbstractRetinopathy of prematurity (ROP) is a vasoproliferative retinal disease affecting premature infants. In addition to prematurity itself and oxygen treatment, genetic factors have been suggested to predispose to ROP. We aimed to identify potentially pathogenic genes and biological pathways associated with ROP by analyzing variants from whole exome sequencing (WES) data of premature infants. As part of a multicenter ROP cohort study, 100 non-Hispanic Caucasian preterm infants enriched in phenotypic extremes were subjected to WES. Gene-based testing was done on coding nonsynonymous variants. Genes showing enrichment of qualifying variants in severe ROP compared to mild or no ROP from gene-based tests with adjustment for gestational age and birth weight were selected for gene set enrichment analysis (GSEA). Mean BW of included infants with pre-plus, type-1 or type 2 ROP including aggressive posterior ROP (n = 58) and mild or no ROP (n = 42) were 744 g and 995 g, respectively. No single genes reached genome-wide significance that could account for a severe phenotype. GSEA identified two significantly associated pathways (smooth endoplasmic reticulum and vitamin C metabolism) after correction for multiple tests. WES of premature infants revealed potential pathways that may be important in the pathogenesis of ROP and in further genetic studies.

scholarly journals Risk Factors Associated with Retinopathy of Prematurity in Very and Extremely Preterm Infants

Medicina ◽  
2021 ◽  
Vol 57 (5) ◽  
pp. 420
Author(s):  
Claudia Ioana Borțea ◽  
Florina Stoica ◽  
Marioara Boia ◽  
Emil Radu Iacob ◽  
Mihai Dinu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Preterm Infants ◽  
Gestational Age ◽  
Retinopathy Of Prematurity ◽  
Univariate Analysis ◽  
Significant Risk ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Surfactant Administration ◽  
Stage 1

Background and Objectives: Retinopathy of prematurity (ROP) is the leading cause of blindness in preterm infants. We studied the relationship between different perinatal characteristics, i.e., sex; gestational age (GA); birth weight (BW); C-reactive protein (CRP) and lactate dehydrogenase (LDH) concentrations; ventilation, continuous positive airway pressure (CPAP), and surfactant administration; and the incidence of Stage 1–3 ROP. Materials and Methods: This study included 247 preterm infants with gestational age (GA) < 32 weeks that were successfully screened for ROP. Univariate and multivariate binary analyses were performed to find the most significant risk factors for ROP (Stage 1–3), while multivariate multinomial analysis was used to find the most significant risk factors for specific ROP stages, i.e., Stage 1, 2, and 3. Results: The incidence of ROP (Stage 1–3) was 66.40% (164 infants), while that of Stage 1, 2, and 3 ROP was 15.38% (38 infants), 27.53% (68 infants), and 23.48% (58 infants), respectively. Following univariate analysis, multiple perinatal characteristics, i.e., GA; BW; and ventilation, CPAP, and surfactant administration, were found to be statistically significant risk factors for ROP (p < 0.001). However, in a multivariate model using the same characteristics, only BW and ventilation were significant ROP predictors (p < 0.001 and p < 0.05, respectively). Multivariate multinomial analysis revealed that BW was only significantly correlated with Stage 2 and 3 ROP (p < 0.05 and p < 0.001, respectively), while ventilation was only significantly correlated with Stage 2 ROP (p < 0.05). Conclusions: The results indicate that GA; BW; and the use of ventilation, CPAP, and surfactant were all significant risk factors for ROP (Stage 1–3), but only BW and ventilation were significantly correlated with ROP and specific stages of the disease, namely Stage 2 and 3 ROP and Stage 2 ROP, respectively, in multivariate models.

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