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Flow-cycled Ventilation in Preterm Infants

NCT02522455 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-12-04

No results posted yet for this study

Summary

This short pilot study is to assess the tolerance of preterm infants, born below 32 weeks gestation with respiratory distress syndrome, to flow-cycle ventilation, and see if infants require less overall pressure from the ventilator than the usual conventional settings used, with the aim of providing data to construct a larger trial looking at the longer term outcome of these infants using this type of ventilation in the future.

Many preterm infants at these gestations require assistance from a ventilator due to the immaturity of their lungs. The lungs of preterm infants are susceptible to damage, especially if high pressures are needed or prolonged periods of ventilation. There is concern that if the infant's breathing pattern does not synchronise with the ventilator, this causes additional distress, longer duration of ventilation needed and increased risk of complications. Over the past 20 years, a different type of ventilation, known as flow-cycle ventilation, has been trialed, with limited use in preterm infants. This allows the baby to determine the duration of breathing in and out and how many breaths they require per minute. This would help babies to synchronise better with the ventilator, and consequently require less pressure from the ventilator.

This pilot study is being conducted at St. Mary's Hospital, Manchester. All babies born under 32 weeks gestation, with a stable respiratory effort, will be eligible for consideration for the study. The study will last no longer than 5 hours and involve the babies receiving different pressures from the ventilator in flow-cycle mode for 1-hour epochs. Blood gases after each epoch and continuous ventilator data will be downloaded to assess their tolerance on the different settings, before being returned to the usual conventional settings used on the unit. The babies will have continuous monitoring throughout as per standard neonatal intensive care.

Conditions

  • Neonatal Respiratory Distress Syndrome

Interventions

OTHER

Flow-cycle ventilation

Pressure support level set as per previous pressure requirements to deliver a tidal volume of 5ml/kg (the same pressure amount used as the peak inspiratory pressure in the time-cycled mode)

OTHER

Time-cycle ventilation mode

Peak inspiratory pressure set to deliver 5ml/kg tidal volume, Rate set as per previous requirements

Sponsors & Collaborators

  • University of Leeds

    collaborator OTHER

  • Manchester University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Simon J Mitchell, MD FRCPCH · Manchester University NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Hours
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02522455 on ClinicalTrials.gov