RecruitingACTRN12611000628943

Is bias gas flow in ventilated preterm babies related to lung injury and risk of bronchopulmonary dysplasia?

Ventilator bias gas flows in extremely preterm or extremely low birth weight babies: does a low bias gas flow compared with standard settings decrease concentrations of IL-8 in tracheal secretions and blood and the number of ventilated days?


Sponsor

University of Auckland

Enrollment

180 participants

Start Date

Jul 27, 2012

Study Type

Interventional

Conditions

Summary

Mechanical ventilation of preterm babies has increased their survival over the last decades; however, ventilation also results in injury to the delicate immature lung. Several aspects of ventilation have been identified as contributing to this injury, including the pressure generated by the ventilator and the volume of gas delivered, which have led to advances in ventilatory strategies. To generate the pressure and tidal volume necessary to ventilate a patient, a ventilator applies a continuous bias gas flow running through the ventilator circuit. During ventilation of the preterm baby, this bias gas flow is normally set at 8-10 L/min, independent of babies’ weights and without evidence for this to be the correct setting. However, high compared to low ventilator bias gas flows have been proven to be more injurious for the immature lamb lung. This study will compare preterm babies ventilated at either the standard gas flow of 10 L/min, or a low gas flow of 4 L/min. Outcomes will be measurement of levels of inflammatory markers and duration and intensity of respiratory support


Eligibility

Sex: Both males and femalesMin Age: 0 DayssMax Age: 7 Dayss

Plain Language Summary

Simplified for easier understanding

This study looks at whether the speed of gas flow used in a ventilator (breathing machine) affects lung injury in very premature babies. Extremely premature babies often need ventilators to breathe, but ventilator use can sometimes damage their delicate lungs. Researchers are comparing the standard gas flow setting with a lower flow setting to see if the lower setting causes less inflammation and lung damage. You may be eligible if: - Your baby was born before 28 weeks of pregnancy, or weighs less than 1,000 grams at birth - Your baby needs mechanical ventilation (a breathing machine) in the first week of life You may NOT be eligible if: - Your baby has a congenital heart or lung defect - Your baby has a known chromosomal or genetic abnormality Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Arm 1:Conventional ventilation via ETT at a bias gas flow of 4 L/min Arm 2: Conventional ventilation via ETT at a bias gas flow of 10 L/min Duration; each time ventilation is indicated up to 36 week

Arm 1:Conventional ventilation via ETT at a bias gas flow of 4 L/min Arm 2: Conventional ventilation via ETT at a bias gas flow of 10 L/min Duration; each time ventilation is indicated up to 36 weeks’ corrected gestational age


Locations(2)

Auckland, New Zealand

Christchurch, New Zealand

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ACTRN12611000628943