Speed of Lung Inflation During Ventilation of Extremely Preterm Infants

NCT07101419 | Not Yet Recruiting

• 1 other identifier: 117784
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 3

Brief Summary

Babies born extremely preterm (\<28 weeks of pregnancy) require support to breathe. Some babies require help to breathe from a breathing machine (mechanical ventilator). While this keeps babies alive, it may damage their lungs. To reduce this damage, doctors and nurses take particular care to try and provide the gentlest breathing support possible. However, evidence is still required to determine how to best support babies' breathing, whilst preventing lung damage and longer-term lung problems. This clinical trial aims to compare two ways of adjusting a common setting on the breathing machine. This setting is called the pressure rise time or PRT. The PRT determines how quickly the breathing machine inflates a premature baby's lungs. A short PRT quickly inflates the lungs. A long PRT inflates the lungs more slowly. Previous research suggests that more slowly inflating the baby's lungs may cause less lung damage and still allow oxygen to be delivered to and carbon dioxide to be cleared from the lungs. However, larger studies are required to determine whether this should become the standard treatment. This study investigates whether inflating the baby's lungs more slowly (long PRT) using the breathing machine is as effective as the PRT setting currently used (short PRT, more quickly inflating the lungs). The main question it aims to answer is: Does how quickly the breathing machine inflates an extremely preterm baby's lung impact their oxygen levels?

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in peripheral oxygen saturation to fraction of inspired oxygen ratio (S/F Ratio) measured each minute during each treatment period (0 minutes to 4 hours)

  0 minutes then each minute up to 4 hours for each of the Long PRT and Short PRT 4-hour treatment periods

Secondary Outcomes (19)

• Change in pressure rise time (PRT) measured each minute during each treatment period (0 minutes to 4 hours).

  Measured during each of the Long PRT and Short PRT 4-hour treatment periods.

• Change in mean airway pressure (MAP) measured each minute during each treatment period (0 minutes to 4 hours).

  Measured during of the Long PRT and Short PRT 4-hour treatment periods.

• Change in positive end expiratory pressure (PEEP) measured each minute during each treatment period (0 minutes to 4 hours).

  Measured during each of the Long PRT and Short PRT 4-hour treatment periods.

• Change in peak inspiratory pressure (PIP) measured each minute during each treatment period (0 minutes to 4 hours).

  Measured during each of the Long PRT and Short PRT 4-hour treatment periods.

• Change in tidal volume (VT) measured each minute during each treatment period (0 minutes to 4 hours).

  Measured during each of the Long PRT and Short PRT 4-hour treatment periods.

Study Arms (2)

Long-Short PRT Sequence

EXPERIMENTAL

Long PRT set during first treatment period; Short PRT set during second treatment period

Other: Long PRT; Other: Short PRT

Short-Long PRT Sequence

EXPERIMENTAL

Short PRT set during first treatment period; Long PRT set during second treatment period

Other: Long PRT; Other: Short PRT

Interventions

Long PRT OTHER

PRT (in seconds) set at 75% of inspiratory time (in seconds)

Also known as: Long Pressure Rise Time

Long-Short PRT Sequence; Short-Long PRT Sequence

Short PRT OTHER

PRT (in seconds) set at 33% of inspiratory time (in seconds).

Also known as: Short Pressure Rise Time

Long-Short PRT Sequence; Short-Long PRT Sequence

Eligibility Criteria

• Age: 6 Hours - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Admitted to participating neonatal intensive care unit
• Born between 22+0 to 27+6 weeks' gestation
• Current weight ≥400 grams
• Receiving synchronised, patient-triggered, volume-targeted (all breaths) conventional mechanical ventilation (Pressure Control-Assist Control + Volume Guarantee \[PC-AC+VG\] mode on Dräger Babylog VN500/800 ventilators) initiated within 72-hours post birth
• Postnatal age ≥6 hours and ≤7 days
• Received surfactant therapy
• Clinically stable (as per treating and research team consensus)
• Parent(s)/legal guardian provides prospective informed consent.

You may not qualify if:

• Major congenital anomaly involving the cardiac, respiratory or 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 22 weeks in which the neonatal consultant anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early postnatal life
• Receiving (or expected to receive within the next 12 hours) any other mode of mechanical ventilation including synchronised intermittent mandatory ventilation (SIMV), pressure support ventilation (PSV) or high-frequency oscillatory ventilation
• Planned for extubation from mechanical ventilation within the next 12 hours.

Sponsors & Collaborators

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

Study Sites (3)

Mercy Hospital for Women

Heidelberg, Victoria, Australia

Location

The Royal Women's Hospital

Parkville, Victoria, 3051, Australia

Location

Joan Kirner Women's and Children's Hospital

Saint Albans, Victoria, 3021, Australia

Location

Related Publications (5)

• Tingay DG, Fatmous M, Kenna K, Chapman J, Douglas E, Sett A, Poh QH, Dahm SI, Quach TK, Sourial M, Fang H, Greening DW, Pereira-Fantini PM. Speed of lung inflation at birth influences the initiation of lung injury in preterm lambs. JCI Insight. 2024 Aug 6;9(18):e181228. doi: 10.1172/jci.insight.181228.

  PMID: 39106107 BACKGROUND

• Bach KP, Kuschel CA, Patterson N, Skwish H, Huth S, Phua HH, Bloomfield FH. Effect of Bias Gas Flow on Tracheal Cytokine Concentrations in Ventilated Extremely Preterm Infants: A Randomized Controlled Trial. Neonatology. 2021;118(3):332-339. doi: 10.1159/000515364. Epub 2021 Apr 7.

  PMID: 33827091 BACKGROUND

• Bach KP, Kuschel CA, Oliver MH, Bloomfield FH. Ventilator gas flow rates affect inspiratory time and ventilator efficiency index in term lambs. Neonatology. 2009;96(4):259-64. doi: 10.1159/000220765. Epub 2009 May 27.

  PMID: 19478530 BACKGROUND

• Bach KP, Kuschel CA, Hooper SB, Bertram J, McKnight S, Peachey SE, Zahra VA, Flecknoe SJ, Oliver MH, Wallace MJ, Bloomfield FH. High bias gas flows increase lung injury in the ventilated preterm lamb. PLoS One. 2012;7(10):e47044. doi: 10.1371/journal.pone.0047044. Epub 2012 Oct 8.

  PMID: 23056572 BACKGROUND

• Chong D, Kayser S, Szakmar E, Morley CJ, Belteki G. Effect of pressure rise time on ventilator parameters and gas exchange during neonatal ventilation. Pediatr Pulmonol. 2020 May;55(5):1131-1138. doi: 10.1002/ppul.24724. Epub 2020 Mar 9.

  PMID: 32150670 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

• Kristin N Ferguson, BSc MBBS

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin N Ferguson, BSc MBBS

CONTACT

+61383416200; kristin.ferguson@mcri.edu.au

Study Design

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

Model Details: Extremely preterm infants on synchronised, patient-triggered, volume targeted conventional mechanical ventilation are managed with each pressure rise time (PRT) setting for 4 hours (treatment period 1), prior to crossing over to the other PRT setting for a further 4 hours (treatment period 2). There will be a 1-2 hour preparatory washout phase prior to treatment period 1 and another 1-2 hour washout between treatment period 1 and 2. Infants will be monitored for a further 12-hours post-completion of the crossover trial for safety events.

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-07

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 (3)