Effect of Automated Oxygen Control on Early-childhood Lung Mechanics
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-5
SponsorKing's College Hospital NHS Trust
About this trial
Preterm infants are at higher risk of long-term respiratory problems and abnormal lung function in childhood. Respiratory support including mechanical ventilation, that is the use of a machine to move air into and out of the lungs, and oxygen treatment may further increase the risk of complications. In a randomised controlled trial, closed-loop automated oxygen control (CLAC) was associated with reductions in the duration of mechanical ventilation and oxygen treatment and may, therefore, help reduce long-term respiratory morbidity.
The effect of CLAC systems on lung function has not been explored to date. This prospective observational study aims to explore the effect of automated oxygen control during the neonatal period on lung mechanics in children who were born at less than 34 weeks of gestation and required mechanical ventilation.
The study will take place at King's College Hospital (KCH) children's outpatient department. Parents of children that participated in the randomised trial of automated versus manual oxygen control will be approached, informed and if appropriate consented to join the study.
The study will measure outcomes including lung mechanics and parent-reported respiratory morbidity (breathing difficulties, respiratory infections, hospital admissions after discharge from neonatal care). Results will be compared between the two groups.
Lung mechanics will be assessed using a technique called forced oscillation. This is a technique which involves the patient breathing through a face mask (if less than two years of age) or a mouthpiece filter (if older than two years). It is a non-invasive technique that measures lung function by superimposing gentle air pressure waves onto the patient's spontaneous breathing.An average of three measurements each one lasting up to 20 seconds will be performed.
Parents will be asked to fill in a questionnaire regarding the health of their child after discharge from the neonatal unit.
The study's duration will be 12 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
survived to early childhood
do not require continuous non-invasive ventilation
do not have a tracheostomy.
Disqualifiers
Infants excluded from the previous randomised trial
Infants who did not survive to early childhood
Survivors in need of continuous non-invasive ventilation
Survivors with a tracheostomy
Trial population
Preterm-born children requiring mechanical ventilation at birth who participated in a randomised controlled trial of automated versus manual oxygen control.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Forced oscillometry technique
Other interventionPatients will be assessed in a seated position with a nose clip in place and the investigator will support their cheeks and lower jaw. Children who cannot tolerate the nose clip will have their nose held by their accompanying parent/guardian. The participants will be breathing through a standard mouthpiece filter. Each FOT will be performed for 20 seconds. Testing will be repeated until a minimum of three tests is obtained with coherence of variance (CoV) equal or less than 15% at R5. The mean results of at least two adequate measurements will be used for analysis. For infants less than two years of age the TremoFlo N-100 Airwave Oscillometry System (Thorasys Thoracic Medical Systems Inc. Montreal, Quebec, Canada) will be used. The infants will be placed in supine position and will be breathing via a cushioned face mask covering the nose and mouth and a filter (Humid-Vent Filter Small, Teleflex Medical, Ireland). Measurements will be performed at the same frequencies.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Preterm-born children at one to five years of age1 intervention
Trial outcomes
Primary outcomes
1
The increase in respiratory resistance (R) in centimeters water per liter per second of participants who received automated oxygen control in the neonatal period compared to those who received manual oxygen control.
Time frame
From enrollment to the end of monitoring at one hour.2
The reduction in respiratory reactance (X) in centimeters water per liter per second of participants who received automated oxygen control in the neonatal period compared to those who received manual oxygen control.
Time frame
From enrollment to the end of monitoring at one hour.Secondary outcomes
1
To evaluate differences in the frequency of episodes of breathing difficulties (number of episodes per month) after discharge from neonatal care with the use of parent-questionnaires.
Time frame
From enrolment to the end of monitoring at one hour.2
To evaluate differences in the absolute number of courses of antibiotics given for respiratory infections after discharge from neonatal care with the use of parent-questionnaires.
Time frame
From enrollment to the end of monitoring at one hour.3
To evaluate differences in the absolute number of hospital readmissions after discharge from neonatal care with the use of parent-questionnaires.
Time frame
From enrollment to the end of monitoring at one hour.Sponsors and contacts
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Source ClinicalTrials.gov
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