Pressure-limited Ventilation Versus Volume-targeted Ventilation in Preterm Newborns
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01531010 |
Recruitment Status :
Completed
First Posted : February 10, 2012
Last Update Posted : February 10, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for preterm infants in comparison to pressure-limited ventilation. This study aims to compare pressure-limited to VTV in preterm infants.
Hypothesis: Volume-targeted will be associated with more rapid achievement of weaning criteria compared to pressure-limited ventilation
Primary outcome: Time taken to achieve pre-specified weaning criteria.
Methods: Ventilated infants less than 34 weeks gestational age at birth were recruited within the first 24 hours of life and randomly allocated to receive either pressure-limited or VTV. Adjustments to ventilator settings were made according to the trial protocol. Infants were deemed to have met failure criteria if they required HFOV, required peak pressures of more than 26 cm of water or developed pulmonary haemorrhage. Analysis will be by intention-to-treat.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neonatal Respiratory Failure | Device: Ventilation protocol delivered by the SLE5000 ventilator | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomised Controlled Trial of Pressure-limited Ventilation Versus Volume-targeted Ventilation in Prematurely Born Infants |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | February 2012 |
Actual Study Completion Date : | February 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Pressure-limited ventilation |
Device: Ventilation protocol delivered by the SLE5000 ventilator
In pressure-limited ventilation arm, preferentially wean pressure till weaning criteria achieved, then wean rate. In volume-targeted ventilation arm, set target volume at 5ml/kg and wean rate. In both arms, aim to keep blood gases within normal limits. |
Active Comparator: Volume-targeted ventilation |
Device: Ventilation protocol delivered by the SLE5000 ventilator
In pressure-limited ventilation arm, preferentially wean pressure till weaning criteria achieved, then wean rate. In volume-targeted ventilation arm, set target volume at 5ml/kg and wean rate. In both arms, aim to keep blood gases within normal limits. |
- Time to achieve weaning criteriaPeak inspiratory pressure (PIP) of 16 cm of water or less AND fraction of inspired oxygen of 0.4 or less for at least 6 hours

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 24 Hours (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Mechanically ventilated
- <34 weeks gestation
- Within first 24 hours of life
Exclusion Criteria:
- Congenital diaphragmatic hernia
- Congenital heart disease
- Oesophageal atresia

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531010
United Kingdom | |
King's College Hospital NHS Foundation Trust | |
London, United Kingdom, SE5 9RS |
Responsible Party: | Anne Greenough, Professor of Neonatology and Clinical Respiratory Physiology, King's College London |
ClinicalTrials.gov Identifier: | NCT01531010 |
Other Study ID Numbers: |
07/H0808/147-2 |
First Posted: | February 10, 2012 Key Record Dates |
Last Update Posted: | February 10, 2012 |
Last Verified: | February 2012 |
Neonate Premature Pressure limited ventilation Volume ventilation |
Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases |