Effects of targeting lower versus higher arterial oxygen saturations on death or disability in preterm infants.
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ABSTRACT:
SUBMITTER: Askie LM
PROVIDER: S-EPMC6478245 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Optimal starting oxygen concentration for delivery room resuscitation of extremely preterm infants (<29 weeks) remains unknown, with recommendations of 21-30% based on uncertain evidence. Individual patient randomized trials designed to answer this question have been hampered by poor enrolment. It is feasible to compare 30% vs. 60% starting oxygen for delivery room resuscitation of extremely preterm infants using a change in local hospital policy and deferred consent approach. Prospective, single-center, feasibility study, with each starting oxygen concentration used for two months for all eligible infants. Infants born at 23 + 0-28 + 6 weeks' gestation who received delivery room resuscitation. Study interventions: Initial oxygen at 30% or 60%, increasing by 10-20% every minute for heart rate < 100 bpm, or increase to 100% for chest compressions. Feasibility, defined by (i) achieving difference in cumulative supplied oxygen concentration between groups, and (ii) post-intervention rate consent >50%. Thirty-four infants were born during a 4-month period; consent was obtained in 63%. Thirty (n = 12, 30% group; n = 18, 60% group) were analyzed, including limited data from eight who died or were transferred before parents could be approached. Median cumulative oxygen concentrations were significantly different between the two groups in the first 5 min. Randomized control trial of 30% or 60% oxygen at the initiation of resuscitation of extremely preterm neonates with deferred consent is feasible. Clinicaltrials.gov NCT03706586.
| S-EPMC8625238 | biostudies-literature
Project description:BackgroundEmerging evidence suggests that initiating delivery room respiratory support or resuscitation for term infants using lower rather than higher concentrations of oxygen reduces mortality and the risk of serious morbidity. Uncertainty exists with regard to applicability of this strategy for preterm infants who have different underlying reasons for respiratory distress and risks for harm at birth than term infants.MethodsWe performed a systematic review and meta-analysis of randomised controlled trials to determine the effect on mortality and morbidity of using lower (21- 50%) versus higher (>50%) oxygen concentrations for delivery room transition support of preterm infants.ResultsWe identified six randomised controlled trials in which a total of 484 infants participated. Most participants were preterm infants born before 32 weeks' gestation. One trial was quasi-randomised and in one trial allocation concealment was not described. Clinicians and investigators were aware of the interventions in all but one trial. Meta-analyses found a statistically significant reduction in the risk of death pooled risk ratio 0.65 (95% confidence interval 0.43, 0.98), but this effect disappeared when only the four trials with adequate allocation concealment were included [pooled risk ratio 1.0 (95% confidence interval 0.45, 2.24)]. None of the trials has evaluated any neuro-developmental outcomes.ConclusionsThe available trial data do not provide strong evidence that using lower versus higher oxygen concentrations for delivery room transition support for preterm infants confers important benefits or harms. Lack of allocation concealment and blinding of clinicians and assessors are the major sources of bias in the existing trials. Further, large, good-quality trials are needed to resolve on-going uncertainties and inform clinical practice.
| S-EPMC3527365 | biostudies-literature
Project description:BackgroundLimited data suggest that higher hemoglobin thresholds for red-cell transfusions may reduce the risk of cognitive delay among extremely-low-birth-weight infants with anemia.MethodsWe performed an open, multicenter trial in which infants with a birth weight of 1000 g or less and a gestational age between 22 weeks 0 days and 28 weeks 6 days were randomly assigned within 48 hours after delivery to receive red-cell transfusions at higher or lower hemoglobin thresholds until 36 weeks of postmenstrual age or discharge, whichever occurred first. The primary outcome was a composite of death or neurodevelopmental impairment (cognitive delay, cerebral palsy, or hearing or vision loss) at 22 to 26 months of age, corrected for prematurity.ResultsA total of 1824 infants (mean birth weight, 756 g; mean gestational age, 25.9 weeks) underwent randomization. There was a between-group difference of 1.9 g per deciliter (19 g per liter) in the pretransfusion mean hemoglobin levels throughout the treatment period. Primary outcome data were available for 1692 infants (92.8%). Of 845 infants in the higher-threshold group, 423 (50.1%) died or survived with neurodevelopmental impairment, as compared with 422 of 847 infants (49.8%) in the lower-threshold group (relative risk adjusted for birth-weight stratum and center, 1.00; 95% confidence interval [CI], 0.92 to 1.10; P = 0.93). At 2 years, the higher- and lower-threshold groups had similar incidences of death (16.2% and 15.0%, respectively) and neurodevelopmental impairment (39.6% and 40.3%, respectively). At discharge from the hospital, the incidences of survival without severe complications were 28.5% and 30.9%, respectively. Serious adverse events occurred in 22.7% and 21.7%, respectively.ConclusionsIn extremely-low-birth-weight infants, a higher hemoglobin threshold for red-cell transfusion did not improve survival without neurodevelopmental impairment at 22 to 26 months of age, corrected for prematurity. (Funded by the National Heart, Lung, and Blood Institute and others; TOP ClinicalTrials.gov number, NCT01702805.).
| S-EPMC8487591 | biostudies-literature
Project description:ImportanceThere are potential benefits and harms of hyperoxemia and hypoxemia for extremely preterm infants receiving more vs less supplemental oxygen.ObjectiveTo compare the effects of different target ranges for oxygen saturation as measured by pulse oximetry (Spo2) on death or major morbidity.Design, setting, and participantsProspectively planned meta-analysis of individual participant data from 5 randomized clinical trials (conducted from 2005-2014) enrolling infants born before 28 weeks' gestation.ExposuresSpo2 target range that was lower (85%-89%) vs higher (91%-95%).Main outcomes and measuresThe primary outcome was a composite of death or major disability (bilateral blindness, deafness, cerebral palsy diagnosed as ≥2 level on the Gross Motor Function Classification System, or Bayley-III cognitive or language score <85) at a corrected age of 18 to 24 months. There were 16 secondary outcomes including the components of the primary outcome and other major morbidities.ResultsA total of 4965 infants were randomized (2480 to the lower Spo2 target range and 2485 to the higher Spo2 range) and had a median gestational age of 26 weeks (interquartile range, 25-27 weeks) and a mean birth weight of 832 g (SD, 190 g). The primary outcome occurred in 1191 of 2228 infants (53.5%) in the lower Spo2 target group and 1150 of 2229 infants (51.6%) in the higher Spo2 target group (risk difference, 1.7% [95% CI, -1.3% to 4.6%]; relative risk [RR], 1.04 [95% CI, 0.98 to 1.09], P = .21). Of the 16 secondary outcomes, 11 were null, 2 significantly favored the lower Spo2 target group, and 3 significantly favored the higher Spo2 target group. Death occurred in 484 of 2433 infants (19.9%) in the lower Spo2 target group and 418 of 2440 infants (17.1%) in the higher Spo2 target group (risk difference, 2.8% [95% CI, 0.6% to 5.0%]; RR, 1.17 [95% CI, 1.04 to 1.31], P = .01). Treatment for retinopathy of prematurity was administered to 220 of 2020 infants (10.9%) in the lower Spo2 target group and 308 of 2065 infants (14.9%) in the higher Spo2 target group (risk difference, -4.0% [95% CI, -6.1% to -2.0%]; RR, 0.74 [95% CI, 0.63 to 0.86], P < .001). Severe necrotizing enterocolitis occurred in 227 of 2464 infants (9.2%) in the lower Spo2 target group and 170 of 2465 infants (6.9%) in the higher Spo2 target group (risk difference, 2.3% [95% CI, 0.8% to 3.8%]; RR, 1.33 [95% CI, 1.10 to 1.61], P = .003).Conclusions and relevanceIn this prospectively planned meta-analysis of individual participant data from extremely preterm infants, there was no significant difference between a lower Spo2 target range compared with a higher Spo2 target range on the primary composite outcome of death or major disability at a corrected age of 18 to 24 months. The lower Spo2 target range was associated with a higher risk of death and necrotizing enterocolitis, but a lower risk of retinopathy of prematurity treatment.
| S-EPMC6583054 | biostudies-literature
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| S-EPMC6880382 | biostudies-literature
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| S-EPMC6494253 | biostudies-literature
Project description:BackgroundImmediately after birth, the oxygen saturation is between 30 and 50%, which then increases to 85-95% within the first 10 min. Over the last 10 years, recommendations regarding the ideal level of the initial fraction of inspired oxygen (FiO2) for resuscitation in preterm infants have changed from 1.0, to room air to low levels of oxygen (< 0.3), up to moderate concentrations (0.3-0.65). This leaves clinicians in a challenging position, and a large multi-center international trial of sufficient sample size that is powered to look at safety outcomes such as mortality and adverse neurodevelopmental outcomes is required to provide the necessary evidence to guide clinical practice with confidence.MethodsAn international cluster, cross-over randomized trial of initial FiO2 of 0.3 or 0.6 during neonatal resuscitation in preterm infants at birth to increase survival free of major neurodevelopmental outcomes at 18 and 24 months corrected age will be conducted. Preterm infants born between 230/7 and 286/7 weeks' gestation will be eligible. Each participating hospital will be randomized to either an initial FiO2 concentration of either 0.3 or 0.6 to recruit for up to 12 months' and then crossed over to the other concentration for up to 12 months. The intervention will be initial FiO2 of 0.6, and the comparator will be initial FiO2 of 0.3 during respiratory support in the delivery room. The sample size will be 1200 preterm infants. This will yield 80% power, assuming a type 1 error of 5% to detect a 25% reduction in relative risk of the primary outcome from 35 to 26.5%. The primary outcome will be a composite of all-cause mortality or the presence of a major neurodevelopmental outcome between 18 and 24 months corrected age. Secondary outcomes will include the components of the primary outcome (death, cerebral palsy, major developmental delay involving cognition, speech, visual, or hearing impairment) in addition to neonatal morbidities (severe brain injury, bronchopulmonary dysplasia; and severe retinopathy of prematurity).DiscussionThe use of supplementary oxygen may be crucial but also potentially detrimental to preterm infants at birth. The HiLo trial is powered for the primary outcome and will address gaps in the evidence due to its pragmatic and inclusive design, targeting all extremely preterm infants. Should 60% initial oxygen concertation increase survival free of major neurodevelopmental outcomes at 18-24 months corrected age, without severe adverse effects, this readily available intervention could be introduced immediately into clinical practice.Trial registrationThe trial was registered on January 31, 2019, at ClinicalTrials.gov with the Identifier: NCT03825835.
| S-EPMC10996184 | biostudies-literature
Project description:OBJECTIVE:To explore the relationship between neonatal oxygen saturation and BP at age 6-7 years in a cohort of infants born extremely preterm. STUDY DESIGN:Infants <28 weeks gestation were assigned to a higher or lower oxygen saturation target. Oximeter data were monitored throughout the neonatal period. A subset of survivors was seen at age 6. BP was measured and compared by group assignment, achieved saturations, and time spent in hypoxemia (saturations <80%). RESULTS:There was no difference in systolic or diastolic BP between assigned groups. Median achieved weekly oxygen saturation was not associated with BP. Longer duration of hypoxemia during the first week of age was associated with higher systolic BP. CONCLUSIONS:Neither target nor actual median oxygen saturations in this study was associated with BP at school age. Increased duration of hypoxemia in the first postnatal week was associated with higher systolic BP at 6-7 years of age.
| S-EPMC7260090 | biostudies-literature
Project description:Randomized controlled trials evaluating low-target oxygen saturation (SpO2:85% to 89%) vs high-target SpO2 (91% to 95%) have shown variable results regarding mortality and morbidity in extremely preterm infants. Because of the variation inherent to the accuracy of pulse oximeters, the unspecified location of probe placement, the intrinsic relationship between SpO2 and arterial oxygen saturation (SaO2) and between SaO2 and partial pressure of oxygen (PaO2) (differences in oxygen dissociation curves for fetal and adult hemoglobin), the two comparison groups could have been more similar than dissimilar. The SpO2 values were in the target range for a shorter period of time than intended due to practical and methodological constraints. So the studies did not truly compare 'target SpO2 ranges'. In spite of this overlap, some of the studies did find significant differences in mortality prior to discharge, necrotizing enterocolitis and severe retinopathy of prematurity. These differences could potentially be secondary to time spent beyond the target range (SpO2 <85 or >95%) and could be avoided with an intermediate but wider target SpO2 range (87% to 93%). In conclusion, significant uncertainty persists about the desired target range of SpO2 in extremely preterm infants. Further studies should focus on studying newer methods of assessing oxygenation and strategies to limit hypoxemia (<85% SpO2) and hyperoxemia (>95% SpO2).
| S-EPMC4281291 | biostudies-literature
Project description:BackgroundSupplemental oxygen is commonly administered to patients after out-of-hospital cardiac arrest. However, the findings from studies on oxygen targeting for out-of-hospital cardiac arrest are inconclusive. Thus, we conducted a systematic review and meta-analysis to evaluate the impact of lower oxygen target compared with higher oxygen target on patients after out-of-hospital cardiac arrest.MethodsWe searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, from inception to February 6, 2023, for randomized controlled trials comparing lower and higher oxygen target in adults (aged ≥ 18 years) after out-of-hospital cardiac arrest. We screened studies and extracted data independently. The primary outcome was mortality at 90 days after cardiac arrest. We assessed quality of evidence using the grading of recommendations assessment, development, and evaluation approach. This study was registered with PROSPERO, number CRD42023409368.ResultsThe analysis included 7 randomized controlled trials with a total of 1451 participants. Compared with lower oxygen target, the use of a higher oxygen target was not associated with a higher mortality rate (relative risk 0.97, 95% confidence intervals 0.82 to 1.14; I2 = 25%). Findings were robust to trial sequential, subgroup, and sensitivity analysis.ConclusionLower oxygen target did not reduce the mortality compared with higher oxygen target in patients after out-of-hospital cardiac arrest.
| S-EPMC10588244 | biostudies-literature