Today the results of the @PlussTrial were published in @JAMA_current!. Intratracheal budesonide mixed with surfactant to increase survival free of BPD in extremely preterm infants born <28 weeks’ gestation . A thread 🧵 (1/X) #neotwitter

RT @CEBU_Melbourne: Huge congratulations to the @PlussTrial team and our amazing statisticians, Kate Francis and Susan Donath, for their do….

Today the @PlussTrial was awarded the @ACTA_org Clinical Trial of the Year!!! . As always the first people to thank are the incredible families and babies of who took part in the trial 🙏🏻 . And of course thanks and congratulations to the entire @PlussTrial team! . #neoTwitter

RT @BrianKingNeo: The most recent @AAPneonatal Journal Club webinar is available - Dr. Aung (Neonatal-Perinatal Fel….

Steroid and surfactant mix fails to impact bronchopulmonary dysplasia in preterm infants

Early Intratracheal Budesonide Didn't Improve Outcomes for Preterm Infants | MedPage Today

RT @PlussTrial: Today the results of the @PlussTrial were published in @JAMA_current!. Intratracheal budesonide mixed with surfactant to in….

RT @PlussTrial: Link to Editorial of the @PlussTrial results by Erik Jensen @ChildrensPhila:.

RT @JAMA_current: In extremely preterm infants receiving surfactant, early intratracheal budesonide may have little to no effect on surviva….

RT @drbretty: Wonderful commentary by ⁦@NeonatalResearc⁩ on the context and results of the ⁦@PlussTrial⁩! #neotwitter .

RT @drbretty: The @PlussTrial was published today:

RT @NICULived: Did your baby participate? Published today in @JAMA_current - the results of The @PlussTrial!. 21 NICUs in 4 countries - Aus….

Link to Editorial of the @PlussTrial results by Erik Jensen @ChildrensPhila:.

Link to podcast interview 🎙️ with @TracyALieu (@JAMA_current deputy editor) about the @plusstrial results:.

Thanks go first and foremost to the amazing babies and their families that participated in the @plusstrial! 🙏🏻 . And to the sponsor @MCRI_for_kids and funders incl. @nhmrc and @ChiesiGroup . And of course to the wonderful group of investigators who made it all happen! . (13/END)

So, disappointingly 😔, the @PlussTrial found that intratracheal budesonide mixed with surfactant had little or no effect on survival free of BPD in EPTIs…. Longer term outcomes are important and we are currently assessing participants at 2 years of age (PLUSS2). (12/X).

There were no important differences in any secondary outcomes including the need for postnatal systemic CS, home oxygen or durations of resp support or oxygen . There was also no obvious difference in potential steroid side effects between groups . (11/X).

We prespecified subgroup analyses and found no differences by: GA, prior surfactant, mode of support, sex, SGA or chorio. Interestingly, in post hoc analysis by FiO2 at randomization (<0.50 vs. 0.50+) there seemed to be a greater effect of Bud in the higher FiO2 subgroup. (10/X).

The primary outcome of survival free of BPD at 36w PMA was very similar between the groups:. Surf + Bud 25.6% vs. Surf alone 22.6%, aRD 2.7% (95% CI -2.1% to 7.4%). There was also no difference in BPD severity (Jensen et al 2019 criteria). (9/X)

Ultimately 1059 infants were included in the primary analysis. Mean GA and BW were ~25.6 weeks and 775 g - these were smaller and more immature infants than enrolled in the Yeh studies . Almost all mothers had received some ANS, but only about 2/3 had more than 1 dose . (8/X)

Infants could still be enrolled in the @PlussTrial if they’d received 1 prior surfactant dose - a pragmatic decision to ensure as many EPTIs as possible were eligible. The interventions were prepared away from the bedside so that clinicians & researchers were blinded. (7/X)