Environmental or Nasal Cannula Supplemental Oxygen for Preterm Infants: A Randomized Cross-Over Trial

Travers, Colm P.; Carlo, Waldemar A.; Nakhmani, Arie; Bhatia, Saloni; Gentle, Samuel J.; Amperayani, VenkataNagaSai Apurupa; Indic, Premananda; Aban, Inmaculada; Ambalavanan, Namasivayam

doi:10.1016/j.jpeds.2018.03.010

Cited by 14 publications

(19 citation statements)

References 22 publications

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“…Our previous study on oxygen supplementation protocols in infants established fewer IH and lesser time spent in them during OE supplementation mode (12). In the present work, we probed how these macroscopic changes were reflected in oxygen saturation levels at various time scales.…”

Section: Discussionmentioning

confidence: 85%

“…However, in our case, the proportion of hyperoxemic time was comparable between supplementations. Also, there were fewer FiO 2 adjustments while on OE, and there was no difference in the effective FiO 2 concentration between interventions (12). Hence, we cannot currently associate the observed reduction in hypoxemic time while on OE to this effect.…”

Section: Discussionmentioning

confidence: 91%

“…part of a study registered with www.clinicaltrials.gov (NCT02794662). A detailed description of the study protocol and comprehensive clinical information are available in Travers et al (12). Infants receiving oxygen therapy via nasal cannula with flow rates ≤1.0 liter per kilogram per minute or oxygen environment were eligible for inclusion if they met these criteria: off ventilator and/or continuous positive airway pressure support for more than 48 h prior to study entry, in an incubator for thermoregulation.…”

Section: Subjects Data Acquisition and Pre-processingmentioning

confidence: 99%

“…Such infants were labeled as "high-risk" or "1" and the rest were marked as "low-risk" or "0". IH was defined as an event with SpO 2 < 85% and lasting for longer than 10 s (12). N th was chosen as the 75th percentile of all such events aggregated from subjects' data on all days of monitoring.…”

Section: Pulse Oximetry Based Hypoxemia Risk Screeningmentioning

confidence: 99%

“…In one such study comparing low-flow nasal cannula (NC) oxygen supplementation (11) with digitally-set servo-controlled oxygen environment (OE) among preterm infants, we demonstrated that use of OE reduced episodes of IH when compared with NC (12). The most significant result of the study was that during OE, both -IH (defined as SpO 2 < 85% for ≥10 s) and severe hypoxemia (SpO 2 < 80% for ≥10 s)were reduced.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of oxygen supplementation in very preterm infants: Variations of oxygen saturation features and their application to hypoxemic episode based risk stratification

Ramanand

Indic²,

Travers³

et al. 2023

Front. Pediatr.

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BackgroundOxygen supplementation is commonly used to maintain oxygen saturation (SpO2) levels in preterm infants within target ranges to reduce intermittent hypoxemic (IH) events, which are associated with short- and long-term morbidities. There is not much information available about differences in oxygenation patterns in infants undergoing such supplementations nor their relation to observed IH events. This study aimed to describe oxygenation characteristics during two types of supplementation by studying SpO2 signal features and assess their performance in hypoxemia risk screening during NICU monitoring.Subjects and methodsSpO2 data from 25 infants with gestational age <32 weeks and birthweight <2,000 g who underwent a cross over trial of low-flow nasal cannula (NC) and digitally-set servo-controlled oxygen environment (OE) supplementations was considered in this secondary analysis. Features pertaining to signal distribution, variability and complexity were estimated and analyzed for differences between the supplementations. Univariate and regularized multivariate logistic regression was applied to identify relevant features and develop screening models for infants likely to experience a critically high number of IH per day of observation. Their performance was assessed using area under receiver operating curves (AUROC), accuracy, sensitivity, specificity and F1 scores.ResultsWhile most SpO2 measures remained comparable during both supplementations, signal irregularity and complexity were elevated while on OE, pointing to more volatility in oxygen saturation during this supplementation mode. In addition, SpO2 variability measures exhibited early prognostic value in discriminating infants at higher risk of critically many IH events. Poincare plot variability at lag 1 had AUROC of 0.82, 0.86, 0.89 compared to 0.63, 0.75, 0.81 for the IH number, a clinical parameter at observation times of 30 min, 1 and 2 h, respectively. Multivariate models with two features exhibited validation AUROC > 0.80, F1 score > 0.60 and specificity >0.85 at observation times ≥ 1 h. Finally, we proposed a framework for risk stratification of infants using a cumulative risk score for continuous monitoring.ConclusionAnalysis of oxygen saturation signal routinely collected in the NICU, may have extensive applications in inferring subtle changes to cardiorespiratory dynamics under various conditions as well as in informing clinical decisions about infant care.

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Section: Discussionmentioning

confidence: 85%

Section: Discussionmentioning

confidence: 91%

Section: Subjects Data Acquisition and Pre-processingmentioning

confidence: 99%

Section: Pulse Oximetry Based Hypoxemia Risk Screeningmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Comparison of oxygen supplementation in very preterm infants: Variations of oxygen saturation features and their application to hypoxemic episode based risk stratification

Ramanand

Indic²,

Travers³

et al. 2023

Front. Pediatr.

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Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials

Lyle,

Shaikh,

Oslin

et al. 2023

JAMA Netw Open

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ImportanceRepresentativeness of populations within neonatal clinical trials is crucial to moving the field forward. Although racial and ethnic disparities in research inclusion are well documented in other fields, they are poorly described within neonatology.ObjectiveTo describe the race and ethnicity of infants included in a sample of recent US neonatal clinical trials and the variability in this reporting.Evidence ReviewA systematic search of US neonatal clinical trials entered into Cochrane CENTRAL 2017 to 2021 was conducted. Two individuals performed inclusion determination, data extraction, and quality assessment independently with discrepancies adjudicated by consensus.FindingsOf 120 studies with 14 479 participants that met the inclusion criteria, 75 (62.5%) included any participant race or ethnicity data. In the studies that reported race and ethnicity, the median (IQR) percentage of participants of each background were 0% (0%-1%) Asian, 26% (9%-42%) Black, 3% (0%-12%) Hispanic, 0% (0%-0%) Indigenous (eg, Alaska Native, American Indian, and Native Hawaiian), 0% (0%-0%) multiple races, 57% (30%-68%) White, and 7% (1%-21%) other race or ethnicity. Asian, Black, Hispanic, and Indigenous participants were underrepresented, while White participants were overrepresented compared with a reference sample of the US clinical neonatal intensive care unit (NICU) population from the Vermont Oxford Network. Many participants were labeled as other race or ethnicity without adequate description. There was substantial variability in terms and methods of reporting race and ethnicity data. Geographic representation was heavily skewed toward the Northeast, with nearly one-quarter of states unrepresented.Conclusions and RelevanceThese findings suggest that neonatal research may perpetuate inequities by underrepresenting Asian, Black, Hispanic, and Indigenous neonates in clinical trials. Studies varied in documentation of race and ethnicity, and there was regional variation in the sites included. Based on these findings, funders and clinical trialists are advised to consider a 3-point targeted approach to address these issues: prioritize identifying ways to increase diversity in neonatal clinical trial participation, agree on a standardized method to report race and ethnicity among neonatal clinical trial participants, and prioritize the inclusion of participants from all regions of the US in neonatal clinical trials.

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Eligible Infants Included in Neonatal Clinical Trials and Reasons for Noninclusion

Shaikh,

Lyle,

Oslin

et al. 2024

JAMA Netw Open

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ImportanceResults of clinical trials can only represent included participants, and many neonatal trials fail due to insufficient participation. Infants not included in research may differ from those included in meaningful ways, biasing the sample and limiting the generalizability of findings.ObjectiveTo describe the proportion of eligible infants included in neonatal clinical trials and the reasons for noninclusion.Evidence ReviewA systematic search of Cochrane CENTRAL was performed by retrieving articles meeting the following inclusion criteria: full-length, peer-reviewed articles describing clinical trial results in at least 20 human infants from US neonatal intensive care units, published in English, and added to Cochrane CENTRAL between 2017 and 2022. Retrieved articles were screened for inclusion by 2 independent researchers.FindingsIn total 120 articles met inclusion criteria and 91 of these (75.8%) reported the number of infants eligible for participation, which totaled 26 854 in aggregate. Drawing from these, an aggregate of 11 924 eligible infants (44.4%) were included in reported results. Among all eligible infants, most reasons for noninclusion in results were classified as modifiable or potentially modifiable by the research team. Parents declining to participate (8004 infants [29.8%]) or never being approached (2507 infants [9.3%]) were the 2 predominant reasons for noninclusion. Other modifiable reasons included factors related to study logistics, such as failure to appropriately collect data on enrolled infants (859 of 26 854 infants [3.2%]) and other reasons (1907 of 26 854 infants [7.1%]), such as loss to follow-up or eligible participants that were unaccounted for. Nonmodifiable reasons, including clinical change or death, accounted for a small proportion of eligible infants who were not included (858 of 26 854 infants [3.2%]).Conclusions and RelevanceThis systematic review of reporting on eligible infants included and not included in neonatal clinical trials highlights the need for improved documentation on the flow of eligible infants through neonatal clinical trials and may also inform recruitment expectations for trialists designing future protocols. Improved adherence to standardized reporting may clarify which potential participants are being missed, improving understanding of the generalizability of research findings. Furthermore, these findings suggest that future work to understand why parents decline to participate in neonatal research trials and why some are never approached about research may help increase overall participation.

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Environmental or Nasal Cannula Supplemental Oxygen for Preterm Infants: A Randomized Cross-Over Trial

Abstract: ClinicalTrials.gov: NCT02794662.

Cited by 14 publications

References 22 publications

Comparison of oxygen supplementation in very preterm infants: Variations of oxygen saturation features and their application to hypoxemic episode based risk stratification

Comparison of oxygen supplementation in very preterm infants: Variations of oxygen saturation features and their application to hypoxemic episode based risk stratification

Race and Ethnicity of Infants Enrolled in Neonatal Clinical Trials

Eligible Infants Included in Neonatal Clinical Trials and Reasons for Noninclusion

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