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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01531010
Other study ID # 07/H0808/147-2
Secondary ID
Status Completed
Phase N/A
First received February 8, 2012
Last updated February 8, 2012
Start date July 2010
Est. completion date February 2012

Study information

Verified date February 2012
Source King's College London
Contact n/a
Is FDA regulated No
Health authority United Kingdom: South East London Research Ethics Committee 3United Kingdom: National Health Service
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group N/A to 24 Hours
Eligibility Inclusion Criteria:

- Mechanically ventilated

- <34 weeks gestation

- Within first 24 hours of life

Exclusion Criteria:

- Congenital diaphragmatic hernia

- Congenital heart disease

- Oesophageal atresia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.

Locations

Country Name City State
United Kingdom King's College Hospital NHS Foundation Trust London

Sponsors (1)

Lead Sponsor Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to achieve weaning criteria Peak 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 No
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