PLUSS (Preventing Chronic Lung Disease in Extremely Preterm Infants Using Surfactant + Steroid)-HEARTS (Haemodynamic Echocardiogram Assessment after Receiving Therapy with Steroids) in extremely preterm infants

Not Applicable

Completed

• Conditions: Extremely preterm birth; Patent Ductus Arterious; Reproductive Health and Childbirth - Complications of newborn; Cardiovascular - Other cardiovascular diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12621000822886
• Lead Sponsor: Melbourne Children's Trials Centre

Brief Summary

no summary available yet

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-28
• Study Completion: 2023-06-27
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

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)

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified