Pressure-limited Ventilation Versus Volume-targeted Ventilation in Preterm Newborns

NCT ID: NCT01531010

Last Updated: 2012-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Neonatal Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pressure-limited ventilation

Group Type ACTIVE_COMPARATOR

Ventilation protocol delivered by the SLE5000 ventilator

Intervention Type DEVICE

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.

Volume-targeted ventilation

Group Type ACTIVE_COMPARATOR

Ventilation protocol delivered by the SLE5000 ventilator

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Mechanically ventilated
* \<34 weeks gestation
* Within first 24 hours of life

Exclusion Criteria

* Congenital diaphragmatic hernia
* Congenital heart disease
* Oesophageal atresia
Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role lead

Responsible Party

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Anne Greenough

Professor of Neonatology and Clinical Respiratory Physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King's College Hospital NHS Foundation Trust

London, London, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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07/H0808/147-2

Identifier Type: -

Identifier Source: org_study_id

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