The Ductus Arteriosus and haemodynamics following intra-tracheal Budesonide and surfactant in extremely preterm infants- PLUSS HEARTS Sub study

Melbourne Children's Trials Centre0 个研究点目标入组 158 人开始时间: 2021年6月28日最近更新: 2023年9月26日

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•To be eligible for PLUSS-HEARTS, infants must be enrolled in the PLUSS trial (ACTRN12617000322336) and meet all inclusion and no exclusion criteria.
•Additional inclusion criteria for the PLUSS-HEARTS trial include:
•1.Infant less than 48 hours of age
•2.Infants receiving mechanical ventilation via an endotracheal tube or non-invasive respiratory support including CPAP, NIPPV or nasal high flow, and a clinical decision to treat the infant with exogenous surfactant (first or subsequent dose)

•Criteria for exclusion from the PLUSS Trial (ACTRN12617000322336):includes (any of the following):
•1. Prior treatment with corticosteroids for the prevention of lung disease (inhaled, nebulised, intra-tracheal, or systemic)
•2. Infant is considered non-viable or is not going to be admitted to intensive care
•3. Known or suspected major congenital anomaly that is likely to affect respiratory status (e.g. upper airway obstruction, congenital lung malformation, major congenital heart disease); or severe pulmonary hypoplasia following premature prolonged rupture of fetal membranes with resultant severe oligo/anhydramnios, where the clinician, based on clinical assessment on the first postnatal day, feels survival is unlikely
•4. Infant likely to be transferred to another non-participating NICU within 24 hours of birth
•Additional exclusion criteria for PLUSS-HEARTS include (any of the following):
•1. Treatment with prophylactic indomethacin (with the objective of reducing the risk of intraventricular haemorrhage)
•2. Major congenital heart disease detected on cardiac ultrasound
•3. Unable to perform study cardiac ultrasound due to clinical instability or redirection of care towards comfort measures.

发起方

Melbourne Children's Trials Centre