Impact of Lung Pressure Levels During MIST on Preterm Babies’ Lung Aeration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates the effect of a lung recruitment maneuver administered before minimally invasive surfactant therapy in preterm infants with surfactant deficiency. Eligible babies are born between 24 and 31+6 weeks gestation and require CPAP support with planned MIST administration. The trial uses electrical impedance tomography to monitor lung aeration and aims to see if the maneuver reduces the need for mechanical ventilation within 72 hours. The study is conducted at a single site in Melbourne, Australia, led by Murdoch Children’s Research Institute. Participation depends on parental consent and the infant’s stability and timing of intervention relative to allocation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Born between 24 to 31+6 weeks' gestation, by best obstetric estimate
* Admitted to a participating NICU
* A parent/guardian who can provide informed consent
* Receiving CPAP respiratory support
* Planned to receive MIST by clinicians as standard clinical care
* Clinically stable (as determined by clinical team)
* Infant less than 72 hours of age
* MIST can be administered within 90 min of allocating assigned interventional arm

Exclusion Criteria:

* Receiving any form of respiratory support other than CPAP
* Receiving more than 8 cmH2O PEEP via CPAP in the 4 hours prior to surfactant administration (except in the Delivery Room as part of resuscitation at birth)
* The infant's clinical team has concern regarding clinical stability and tolerability of EIT
* The infant's skin integrity will not tolerate the EIT belt and gel
* Refusal of informed consent by their parent/guardian/legally acceptable representative
* The infant does not have a parent/guardian who can provide informed consent.
* Major congenital anomaly involving the cardiac, respiratory, gastrointestinal systems, or a known genetic syndrome or diagnosis that might affect respiratory course and outcomes
* Severe pulmonary hypoplasia due to anhydramnios or oligohydramnios before 24 weeks in which the neonatal clinician anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early post-natal life
* Suspected or confirmed air leak or pneumothorax
* Previous treatment with surfactant or mechanical ventilation via an endotracheal tube
* Urgent need for intubation and mechanical ventilation as determined by the treating clinician
* Not receiving full active intensive care (i.e. palliative/comfort care)

Where it's running

• Joan Kirner Women's and Children's Hospital
  Saint Albans, Victoria, Australia Recruiting

Study contacts

• Principal investigator: David Tingay — Murdoch Childrens Research Institute
• Study coordinator: Frederique N Donnelly
• Email: frederique.donnelly@mcri.edu.au
• Phone: +61 8341 6200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Video-guided vs direct laryngoscopy for less invasive surfactant delivery in extremely preterm infants

  This trial tests whether using video laryngoscopy helps give surfactant on the first try more often than direct laryngoscopy in extremely preterm babies needing surfactant.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT07426016

• Duration of surfactant administration: 1 minute vs 5 minutes in very preterm babies

  This trial tests whether giving surfactant over 1 minute or 5 minutes during the LISA procedure helps stabilize cerebral and overall oxygen levels in extremely preterm infants.

  Recruiting Phase 4 Medical University of Graz · Graz · NCT07261787

• Evaluating a new surfactant treatment for respiratory distress in preterm infants in Africa

  This study is testing a new way to give surfactant treatment to preterm infants with breathing problems in Africa to see if it helps them do better than the usual care.

  Recruiting at 2 sites Phase 4 Indiana University · Bangui and 7 other locations · NCT06554522

• Less invasive surfactant administration during high-flow oxygen in late preterm and early term infants

  This study tests whether giving surfactant with a less invasive method during high-flow oxygen reduces the need for invasive ventilation in babies born 34 to 38 weeks who have breathing problems after birth.

  Recruiting King's College Hospital NHS Trust · London · NCT06421506

• Comparing two methods for surfactant administration in preterm infants

  This study is testing a new way to give surfactant to preterm infants with breathing problems to see if it helps them breathe better and feel less pain compared to the usual method.

  Recruiting Karolinska Institutet · Stockholm · NCT04445571

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.