To compare the effect of FiO2-C in addition to manual adjustments, in comparison with manual adjustments of FiO2 only, on death and severe complications of prematurity thought to be related to hypoxia/hyperoxia and neurodevelopmental impairment in…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
vroeggeboorte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Composite outcome of death, severe retinopathy of prematurity (ROP), chronic
lung disease or necrotizing enterocolitis until 36 weeks PMA (or, for ROP,
until full vascularization of the retina).
Composite outcome of death, language/ cognitive delay, motor impairment, severe
visual impairment or hearing impairment at 24 months corrected age.
Secondary outcome
Individual components of the primary outcome variables and developmental scores
of the Bayley Scales of Infant Development (3rd edition)
In selected centers only: time within the oxygen saturation target range,
median FiO2, number of manual FiO2 adjustments, time of regional cerebral
oxygenation within target range, cerebral volumes and brain injury by MRI at
term equivalent age.
Background summary
Extremely low gestational age neonates (ELGAN; born below 28 weeks gestational
age) frequently experience intermittent hypoxic/hyperoxemic episodes.
Observational data indicate that severe and prolonged hypoxemic episodes are
associated with rethinopathy of prematurity (ROP) impaired long-term
development and death. Closed-loop automated control of the inspiratory
fraction of oxygen (FiO2-C) reduces time outside the oxygen target range,
decreases number and duration hypo- and hyperoixemic episodes and reduces
caregivers workload. However effects of automated adjustments of FiO2 on
short-term and long-term outcome of preterm infants are not known.
Study objective
To compare the effect of FiO2-C in addition to manual adjustments, in
comparison with manual adjustments of FiO2 only, on death and severe
complications of prematurity thought to be related to hypoxia/hyperoxia and
neurodevelopmental impairment in extremely preterm infants. The primary outcome
measure will be a composite of death, severe ROP, chronic lung disease, or
necrotizing enterocolitis until a postmenstrual age of 36 weeks or until
complete vascularization of the retina, respectively. Key secondary outcome
variables are death or major neurodevelopmental impairment determined at 24
months corrected age and the individual components of the primary outcome, the
developmental scores of the Bayles Scales (3rd Edition) and brain unjiry on
cerebral ultrasound or MRI at term. Safety analyses will assess adverse events
and complications of prematurity.
Study design
Partially observer blinded, randomized, controlled, multicenter parallel group
comparison for superiority.
Intervention
Experimental intervention:
Application of FiO2-C (provided by standard infant ventilators) in addition to
manual adjustments of the inspired oxygen fraction (FiO2) during mechanical
ventilation and continuous positive airway pressure (CPAP) in extreme preterm
infants at least up to 32weeks PMA (or discharge from hospital) according to a
standardized protocol.
Control intervention:
Standard care, i.e. manual adjustments of the FiO2 only
Study burden and risks
Burden is minimal. An extra adhesive band to measure saturations has to be
strapped around foot or hand.
Minimal risk. Based on earlier evidence it is not to be expected that -with
using automated inspired oxygen control by ventilator- a higher amount
saturations will be outside of the targeted range.
Calwerstr. 7
Tübingen 72076
DE
Calwerstr. 7
Tübingen 72076
DE
Listed location countries
Age
Inclusion criteria
Preterm infant born at gestational age 24-28 weeks
Exclusion criteria
Palliative care Congenital anomalies Postnatal age >48 hours No parental
consent No device with automatic FiO2 control
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03168516 |
| CCMO | NL65766.015.18 |