Randomized Trial of a Single Repeat Dose of Prenatal Betamethasone Treatment in Imminent Preterm Birth

Peltoniemi, Outi; Kari, M. Anneli; Tammela, Outi; Lehtonen, Liisa; Marttila, Riitta; Halmesmäki, Erja; Jouppila, Pentti; Hallman, Mikko

doi:10.1097/01.ogx.0000265883.80692.3b

Cited by 23 publications

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“…1 Although the meta-analysis confirmed that repeat antenatal corticosteroid treatment is associated with neonatal benefits, 1 broadly similar to those seen in our trial, some heterogeneity of effect was observed, including 2 trials that showed no apparent benefit. 4,5 Until this heterogeneity is adequately explained and later childhood outcomes are reported for different treatment regimens, we recommend that the inclusion criteria and treatment schedule used in our trial be followed. An important feature of our protocol was that the risk of preterm birth was reevaluated on a weekly basis, so that most women received only 1 or 2 repeat doses.…”

Section: Discussionmentioning

confidence: 99%

Mid-Childhood Outcomes of Repeat Antenatal Corticosteroids: A Randomized Controlled Trial

et al. 2016

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To assess if exposure to repeat dose(s) of antenatal corticosteroids has beneficial effects on neurodevelopment and general health in mid-childhood, at 6 to 8 years' corrected age. METHODS:Women at risk for very preterm birth, who had received a course of corticosteroids ≥7 days previously, were randomized to intramuscular betamethasone (11.4 mg Celestone Chronodose) or saline placebo, repeated weekly if risk of very preterm birth remained. Midchildhood assessments included neurocognitive function, behavior, growth, lung function, blood pressure, health-related quality of life, and health service utilization. The primary outcome was survival free of neurosensory disability. RESULTS:Of the 1059 eligible long-term survivors, 963 (91%) were included in the primary outcome; 479 (91%) in the repeat corticosteroid group and 484 (91%) in the placebo group. The rate of survival free of neurosensory disability was similar in both groups (78.3% repeat versus 77.3% placebo; risk ratio 1.00, 95% confidence interval, 0.94-1.08). Neurodevelopment, including cognitive function, and behavior, body size, blood pressure, spirometry, and health-related quality of life were similar in both groups, as was the use of health services. CONCLUSIONS:Treatment with repeat dose(s) of antenatal corticosteroids was associated with neither benefit nor harm in mid-childhood. Our finding of long-term safety supports the use of repeat dose(s) of antenatal corticosteroids, in view of the related neonatal benefits. For women at risk for preterm birth before 32 weeks' gestation, ≥7 days after an initial course of antenatal corticosteroids, clinicians could consider using a single injection of betamethasone, repeated weekly if risk remains.

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Section: Discussionmentioning

confidence: 99%

Mid-Childhood Outcomes of Repeat Antenatal Corticosteroids: A Randomized Controlled Trial

et al. 2016

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“…This is consistent with our previously published report, which included 249 preterm infants, in which a single repeat dose of ␤ -methasone neither decreased the risk of RDS, nor improved outcome. In fact, in that study, infants born 1-24 h after the repeat ␤ -methasone tended to have a higher incidence of RDS and exhibited a higher requirement for a surfac- tant [23] . In animal studies, an effect of single antenatal ␤ -methasone treatment on early postnatal pulmonary adaptation is found when the time interval between treatment and delivery is 24-48 h [31,32] .…”

Section: Discussionmentioning

confidence: 94%

“…All mothers included were part of a larger clinical trial studying the effect of a repeat antenatal ␤ -methasone dose on the clinical outcome of their preterm infants [23] . Eligibility required imminent preterm birth before 34 weeks GA and that the pregnant woman remained undelivered 7 days after a complete course of antenatal corticosteroid treatment, i.e.…”

Section: Methodsmentioning

confidence: 99%

“…BPD was defined as a requirement for supplemental oxygen or any form of ventilation with continuous distending pressures at 36 weeks or a postnatal age of 4 weeks for infants born after the postmenstrual age of 31 weeks [23,25] . The attending clinicians, blinded to the treatment allocation, made the diagnoses of RDS and BPD.…”

Section: Methodsmentioning

confidence: 99%

“…We therefore hypothesized that a repeat dose of antenatal ␤ -methasone would enhance airway expression of ENaC subunits in the preterm infant. In our previously published randomized, blinded and placebo-controlled clinical trial aimed at investigating whether a single repeat dose of antenatal ␤ -methasone has prognostic effects on respiratory and neurologic outcome [23] , we measured expression of airway ENaC subunits in preterm infants during the early postnatal period. We also tested whether there is an association between expression of ENaC subunits, gestational age (GA) and morbidity due to respiratory distress.…”

Section: ␤ -Methasone and Airway Enacmentioning

confidence: 99%

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Expression of Airway Epithelial Sodium Channel in the Preterm Infant Is Related to Respiratory Distress Syndrome but Unaffected by Repeat Antenatal β-Methasone

Janér¹,

Helve²,

Pitkänen³

et al. 2009

Neonatology

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Background: The airway epithelial sodium channel (ENaC) is rate limiting for postnatal alveolar fluid clearance. Increased lung water content is a feature of respiratory distress syndrome (RDS), which is reduced by antenatal corticosteroid treatment in preterm infants. Objectives: Since corticosteroids also induce ENaC gene expression, we studied whether a repeat dose of antenatal β-methasone affects postnatal expression of airway ENaC. Methods: 17 pregnant women with imminent preterm birth were randomized to receive a single repeat dose of β-methasone (12 mg) or placebo (repeat β-methasone: 8 infants, gestational age (GA) 30.8 ± 2.2 weeks; placebo: 14 infants, GA 30.4 ± 2.7 weeks). Expression of α-, β- and γENaC subunits in nasal epithelium 1–5 and 20–29 h postnatally was analyzed with reverse transcription-PCR. Results: There were no differences between the study groups in RDS incidence or ENaC subunit expression (all p > 0.38). Regression coefficients for association of αENaC expression at 1–5 h with GA in infants with and without RDS differed significantly (p = 0.023). At 20–29 h, αENaC expression was lower in infants with RDS (p = 0.048). Conclusions: A single repeat dose of antenatal β-methasone did not increase ENaC expression, which may in part explain the absence of reduction in RDS incidence.

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Repeat doses of prenatal corticosteroids for women at risk of preterm birth for improving neonatal health outcomes

Crowther

McKinlay

Middleton

et al. 2011

Cochrane Database of Systematic Reviews

164

101

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The short-term benefits for babies of less respiratory distress and fewer serious health problems in the first few weeks after birth support the use of repeat dose(s) of prenatal corticosteroids for women still at risk of preterm birth seven days or more after an initial course. These benefits were associated with a small reduction in size at birth. The current available evidence reassuringly shows no significant harm in early childhood, although no benefit.Further research is needed on the long-term benefits and risks for the woman and baby. Individual patient data meta-analysis may clarify how to maximise benefit and minimise harm.

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Randomized Trial of a Single Repeat Dose of Prenatal Betamethasone Treatment in Imminent Preterm Birth

Cited by 23 publications

References 0 publications

Mid-Childhood Outcomes of Repeat Antenatal Corticosteroids: A Randomized Controlled Trial

Mid-Childhood Outcomes of Repeat Antenatal Corticosteroids: A Randomized Controlled Trial

Expression of Airway Epithelial Sodium Channel in the Preterm Infant Is Related to Respiratory Distress Syndrome but Unaffected by Repeat Antenatal β-Methasone

Repeat doses of prenatal corticosteroids for women at risk of preterm birth for improving neonatal health outcomes

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