Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study

NCT07251790 | Recruiting

• 1 other identifier: 120475
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 2

Brief Summary

Many babies born very preterm (\<32 weeks of pregnancy) require support to breathe from a breathing machine (mechanical ventilator) via a breathing tube. Although this keeps babies alive, it can damage their lungs. To reduce this damage, doctors and nurses try to change babies to gentler breathing support that does not require a breathing tube. This is usually done using a method called nasal continuous positive airway pressure (nCPAP) that uses a nosepiece to deliver breaths. This process of removing the breathing tube is called "extubation". Many babies will need the breathing tube put back in after extubation (for various reasons) and this is independently associated with poorer outcomes. This research study aims to compare two ways of performing extubation - both of which are already used regularly by doctors and nurses. The "standard extubation" approach involves taking a baby's breathing tube out first, then applying the nosepiece and starting nCPAP. The more recent approach, called "prePAP", involves applying the nosepiece and starting nCPAP before taking the breathing tube out. Previous research suggests that a prePAP approach may provide better support for babies during extubation. However, larger studies are required before this approach is more commonly used. This study is investigating whether extubating the baby with prePAP is better than extubating the baby without prePAP. The main question it aims to answer is: Does initiating nCPAP before extubation in very preterm babies reduce the fall in their oxygen levels post-extubation?

Conditions

Respiratory Distress Syndrome in Premature Infant; Respiratory Distress Syndrome, Newborn

Outcome Measures

Primary Outcomes (1)

• Change in peripheral oxygen saturation to fraction of inspired oxygen ratio (SF ratio) measured within 4 hours post-extubation, or until escalation to nasal intermittent positive pressure ventilation or re-intubation.

  0 minutes then each minute up to 15 minutes, then every 15 minutes up to 4 hours post-extubation.

Secondary Outcomes (11)

• CPAP level set at extubation (0 minutes).

  Measured during the extubation procedure.

• Minimum CPAP level set post-extubation (0 minutes to 4 hours).

  Measured from extubation up to 4 hours post-extubation.

• Maximum CPAP level set post-extubation (0 minutes to 4 hours).

  Measured from extubation up to 4 hours post-extubation.

• Incidence of increase in CPAP level post-extubation (0 minutes to 4 hours).

  Completed for each participant at 4 hours post-extubation.

• Change in peripheral oxygen saturation to fraction of inspired oxygen ratio (SF ratio) measured pre-extubation and within 4 hours post-extubation (-5 minutes to 4 hours).

  Measured from 5 minutes pre-extubation up to 4 hours post-extubation.

Study Arms (2)

Extubation with prePAP

EXPERIMENTAL

nCPAP commenced prior to endotracheal tube removal

Procedure: Pre-extubation continuous positive airway pressure

Extubation without prePAP

NO INTERVENTION

nCPAP commenced following endotracheal tube removal

Interventions

Pre-extubation continuous positive airway pressure PROCEDURE

Prior to extubation (2-to-5 minutes) a CPAP hat will be placed on the infant and the circuit set up. A nasal mask will be applied and nCPAP pressure will be commenced at 10 centimetres of water. Only after nCPAP has been in situ for 2 minutes (maximum 5 minutes) will the endotracheal tube be removed.

Also known as: PrePAP

Extubation with prePAP

Eligibility Criteria

• Age: 0 Hours - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The infant is admitted to participating NICU
• The infant is born between 22+0 to 29+6 weeks gestational age
• The infant has been on a form of invasive mechanical ventilation for at least 4 hours
• The infant is being electively extubated for the first time from invasive mechanical ventilation to nCPAP
• The infant is being electively extubated for the first time within 30 days from birth
• The infant is clinically stable (as per clinical and research team consensus)
• The parent(s) or legal guardian(s) provides prospective informed consent.

You may not qualify if:

• The infant is born \<22 weeks or \>30 weeks gestational age
• The infant has a major congenital anomaly involving the cardiac, respiratory or gastrointestinal systems, or a known genetic syndrome or diagnosis that might affect respiratory course and outcomes
• The infant has severe pulmonary hypoplasia due to anhydramnios or oligohydramnios before 22 weeks in which the neonatal clinician anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early postnatal life
• The infant is receiving invasive mechanical ventilation via nasotracheal intubation
• The infant is planned for extubation to any other mode of non-invasive respiratory support than nCPAP, or no respiratory support
• Refusal of informed consent from the parent(s), or the infant does not have a guardian who can provide informed consent.

Sponsors & Collaborators

• Western Health, Australia: collaborator
• Royal Women's Hospital, Melbourne, Australia: collaborator
• Murdoch Childrens Research Institute: lead

Study Sites (2)

The Royal Women's Hospital

Melbourne, Victoria, 3050, Australia

NOT YET RECRUITING

Joan Kirner Women's and Children's Hospital

Saint Albans, Victoria, 3021, Australia

RECRUITING

Related Publications (3)

• Gaertner VD, Ruegger CM. Optimising success of neonatal extubation: Respiratory support. Semin Fetal Neonatal Med. 2023 Oct;28(5):101491. doi: 10.1016/j.siny.2023.101491. Epub 2023 Nov 18.

  PMID: 37993322 BACKGROUND

• Bhatia R, Carlisle HR, Armstrong RK, Kamlin COF, Davis PG, Tingay DG. Extubation generates lung volume inhomogeneity in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):82-86. doi: 10.1136/archdischild-2021-321788. Epub 2021 Jun 23.

  PMID: 34162692 BACKGROUND

• Plastina L, Gaertner VD, Waldmann AD, Thomann J, Bassler D, Ruegger CM. The DELUX study: development of lung volumes during extubation of preterm infants. Pediatr Res. 2022 Jul;92(1):242-248. doi: 10.1038/s41390-021-01699-w. Epub 2021 Aug 31.

  PMID: 34465873 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Georgia S Stephen, BBmedSc BBiomedSc(Hons)

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgia S Stephen, BBmedSc BBiomedSc(Hons)

CONTACT

424701924; georgia.stephen@mcri.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Infants enrolled in the trial will be randomised to receive one of two extubation procedures, placing them in either the "Extubation with prePAP" arm or the "Extubation without prePAP" arm: 1. Arm 1: Extubation with prePAP (intervention): nCPAP commenced prior to endotracheal tube removal 2. Arm 2: Extubation without prePAP (control): nCPAP commenced following endotracheal tube removal For both arms, the intervention period will begin with a 2-to-5-minute pre-extubation period (whilst the infant is still ventilated), followed by a post-extubation period of up to 4 hours, and a follow-up period of up to 7 days (168 hours).

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: November 26, 2025
• Study Start: May 4, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after publication of primary outcome.
• Access Criteria: Prior to releasing any data the following are required: 1. A Data Transfer Agreement must be signed between relevant parties. 2. The MCRI Sponsorship Committee must review and approve your protocol and statistical analysis plan which must include and describe how the data will be used and analysed. 3. An Authorship Agreement to be agreed to and signed between relevant parties. The Agreement must include details regarding appropriate recognition. Authorship may not be justifiable but some form of acknowledgement is requested. 4. Agreement to cover any additional costs relating to the provision of the data. 5. Evidence of ethics approval or waiver of approval, to be compliant with the data transfer agreement and ethics requirements at our end. Data will only be shared with a recognised research institution where the MCRI Sponsorship Committee has approved the proposed analysis plan.

Locations

AU (2)