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Flow-cycled Ventilation in Preterm Infants (FLIPI)

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ClinicalTrials.gov Identifier: NCT02522455
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
University of Leeds
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

Brief 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.


Condition or disease Intervention/treatment Phase
Neonatal Respiratory Distress Syndrome Other: Flow-cycle ventilation Other: Time-cycle ventilation mode Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Flow-cycled Ventilation in Preterm Infants (FLIPI): A Pilot Study Looking at the Tolerance of Flow-cycled Ventilation by Preterm Infants With Respiratory Distress Syndrome
Study Start Date : September 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016


Arm Intervention/treatment
Preterm infants with RDS 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 Name: Pressure-support ventilation

Other: Time-cycle ventilation mode
Peak inspiratory pressure set to deliver 5ml/kg tidal volume, Rate set as per previous requirements
Other Name: Synchronised Intermittent Mandatory Ventilation




Primary Outcome Measures :
  1. Mean airway pressure used [ Time Frame: 6 hours ]
    Amount of pressure required in either ventilation mode

  2. Inspiratory time [ Time Frame: 6 hours ]
    Amount of time the infant require inspiratory support from the ventilator (in flow-cycle mode only)

  3. Respiratory rate [ Time Frame: 6 hours ]
    Spontaneous respiratory rate from infant in either ventilation mode


Secondary Outcome Measures :
  1. Exhaled tidal volume [ Time Frame: 6 hours ]
    Amount of gas exhaled (measured in mls, ml/kg body weight)

  2. Exhaled minute ventilation [ Time Frame: 6 hours ]
    Product of exhaled tidal volume and respiratory rate

  3. Oxygen requirement [ Time Frame: 6 hours ]
  4. Acid - base balance [ Time Frame: In each 1-hour epoch (end of) ]
    Assessment of pH and carbon dioxide clearance in each ventilation mode


Other Outcome Measures:
  1. Rapid shallow breathing index [ Time Frame: 6 hours ]
    Measure of respiratory effort required by infant: calculated by respiratory rate divided by exhaled tidal volume



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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients under 32 weeks gestation at time of study enrolment
  • Evidence of Respiratory Distress Syndrome (Clinical signs of respiratory distress, need for surfactant / ventilation, any O2 requirement with typical Chest radiograph appearance)
  • Patients to have received loading dose of caffeine, as per unit policy
  • Informed parental consent given
  • Intubated and requiring continuing ventilatory support
  • Exogenous surfactant given if indicated (6 hours or more before study entry)
  • Cardiovascular status stable for at least 3 hours before study
  • Stable on ventilation with satisfactory blood gases & inspired oxygen concentration < 40% at time of starting study, and for the preceding 3 hours
  • Regular spontaneous respiratory effort, consistently triggering the ventilator in SIMV mode, for at least 3 hours prior to the start of the study
  • Less than 24 hours of age at the start of the study

Exclusion Criteria:

  • Refusal or withdrawal of parental consent
  • Major congenital abnormality, including any need for surgery
  • Known large intracranial haemorrhage (grade 3 or 4 intraventricular haemorrhage or other significant intracranial abnormality)
  • Seizures
  • Pneumothorax or pulmonary interstitial emphysema
  • Inspired oxygen requirement > 40% after surfactant administration

Information from the National Library of Medicine

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): NCT02522455


Locations
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United Kingdom
St. Mary's Hospital
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Manchester University NHS Foundation Trust
University of Leeds
Investigators
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Study Director: Simon J Mitchell, MD FRCPCH Manchester University NHS Foundation Trust

Publications:

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Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02522455     History of Changes
Other Study ID Numbers: R04003
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Keywords provided by Manchester University NHS Foundation Trust:
Flow-cycled pressure-support ventilation
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Hyaline Membrane Disease
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases