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Effects of Closed-loop Automatic Control of FiO2 in Extremely Preterm Infants (FiO2-C)

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ClinicalTrials.gov Identifier: NCT03168516
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:
Extremely low gestational age neonates (ELGANs), i.e. those born at <28 weeks, frequently experience intermittent hypoxemic/hyperoxemic episodes. Observational data indicate that severe and prolonged hypoxemic episodes are associated with retinopathy 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 of hypo- and hyperoxemic episodes, and reduces caregivers' workload. The proposed observer-blinded randomized controlled trial was designed and will be powered 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 ELGANs. The results of this trial may help to improve the quality of life of ELGANs and reduce the burden of significant morbidity as well as costs for health care and society

Condition or disease Intervention/treatment Phase
Infant,Premature Device: closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Closed-loop Automatic Control of the Inspiratory Fraction of Oxygen (FiO2-C) on Outcome of Extremely Preterm Infants - a Randomized Controlled Parallel Group Multicenter Trial for Safety and Efficacy
Actual Study Start Date : July 27, 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Experimental intervention
closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C)
Device: closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C)
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 ELGANs at least up to 32weeks PMA according to a standardized protocol

No Intervention: Control intervention
Standard care, i.e. manual adjustments of the FiO2 only



Primary Outcome Measures :
  1. Composite outcome of death, severe retinopathy of prematurity (ROP), chronic lung disease of prematurity (BPD), necrotizing enterocolitis (NEC) [ Time Frame: where death, BPD and NEC will be assessed until/at a postmenstrual age (PMA) of 36 weeks and severity of ROP by most severe degree documented until full vascularisation of the retina on repeated ophthal.-exams is reached, at latest at PMA 44 weeks ]
    defined as described in secondary outcome measures

  2. Composite of death or neurodevelopmental impairment (NDI) [ Time Frame: at 24 months of age corrected for prematurity ]
    NDI defined as at least one of the following components: motor disability (GMFCS 2-5), language or cognitive delay (language composite score < 85 or cognitive composite score < 85 on Bayley Scales of Infant Development, 3rd edition) or severe visual or hearing impairment (need for a hearing aid or cochlear implant). This co-primary outcome will only be evaluated confirmatively, if the above stated primary outcome shows a statistically significant effect of the intervention.


Secondary Outcome Measures :
  1. Early Death [ Time Frame: until 36 weeks postmenstrual age (PMA) ]
  2. Late Death [ Time Frame: between 36 weeks PMA and 24 months of age corrected for prematurity ]
  3. ROP Severity Score [ Time Frame: ROP (which may not have fully evolved at 36 weeks PMA) will be assessed until full vascularisation of the retina has been documented on repeated ophthalmological examinations at latest at PMA 44 weeks ]
    The most severe grade of ROP according to 25 categories currently developed by the working group of the international neonatal consortium (may have to be adapted as the consensus process proceeds), documented in either eye (for at least 2 consecutive examinations)

  4. Severe ROP [ Time Frame: ROP (which may not have fully evolved at 36 weeks PMA) will be assessed until full vascularisation of the retina has been documented on repeated ophthalmological examinations at latest at PMA 44 weeks ]
    defined as: ROP stage 0, 1 or 2 (in Zone 2 or 3) = no/non-severe ROP versus 3, 4 or 5, or AP-ROP, or any ROP in Zone 1, or any treatment for ROP = severe ROP

  5. BPD [ Time Frame: until 36 weeks PMA ]
    As part of routine care, the presence of BPD will be determined at 36 weeks postmenstrual age (PMA) according to the physiological definition of Walsh et al. [Walsh, J Perinatol 2003]

  6. NEC [ Time Frame: until 36 weeks PMA ]
    NEC (modified Bell stage ≥ IIA according to [Bell, Ann Surg 1978]) or intestinal perforation will be diagnosed at surgery, at autopsy, or by either the finding of pneumatosis intestinalis, hepatobiliary gas, or free intraperitoneal air on abdominal x-ray, or by demonstration of gas (bubbles) in the portal vein on abdominal ultrasound or abdominal x-ray.

  7. NDI [ Time Frame: at 24 months of age corrected for prematurity ]
    defined as at least one of the following components: motor disability (modified GMFCS 2-5), language or cognitive delay (language composite score < 85 or cognitive composite score < 85 on Bayley Scales of Infant Development, 3rd edition) or severe visual or hearing impairment (need for a hearing aid or cochlear implant)

  8. Language composite score < 85 [ Time Frame: at 24 months of age corrected for prematurity ]
    on Bayley Scales of Infant Development, 3rd edition

  9. Language composite score (language subscale, Bayley III) [ Time Frame: at 24 months corrected age ]
    The raw numerical data of the language-composite-score

  10. Cognitive composite score < 85 [ Time Frame: at 24 months of age corrected for prematurity ]
    on Bayley Scales of Infant Development, 3rd edition

  11. Cognitive composite score [ Time Frame: at 24 months of age corrected for prematurity ]
    The numerical data of the cognitive-composite-score

  12. Cerebral palsy [ Time Frame: at 24 months of age corrected for prematurity ]
    Cerebral palsy will be diagnosed if the child has a non-progressive motor impairment characterized by abnormal muscle tone and impaired range or control of movements, according to the criteria defined by the European network 'Surveillance of CP in Europe'.

  13. Motor disability [ Time Frame: at 24 months of age corrected for prematurity ]
    modified GMFCS 2-5

  14. modified Gross Motor Function Classification Scale (GMFCS) Score [ Time Frame: at 24 months of age corrected for prematurity ]
    GMFCS-Score for quantification of the effects of cerebral palsy and other motor impairments (adapted from Palisano et al. [Palisano Med Child Neurol 1997])

  15. Motor composite score [ Time Frame: at 24 months of age corrected for prematurity ]
    The numerical data of the motor-composite-score

  16. Severe visual impairment [ Time Frame: at 24 months of age corrected for prematurity ]
    defined as an ophthalmological assesment indicating "severe visual impairment", e.g. the best corrected vision in the better eye yields a visual acuity less than 6/60 m (20/200 ft)

  17. Severe hearing impairment [ Time Frame: at 24 months of age corrected for prematurity ]
    defined as need for a hearing aid or cochlear implant



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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm infants with a gestational age (GA) at birth of 23+0/7 - 27+6/7 weeks

Exclusion Criteria:

  • Decision for palliative care
  • congenital anomalies
  • postnatal age > 48h
  • missing parental consent
  • lack of device enabling closed-loop automatic control of FiO2

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): NCT03168516


Contacts
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Contact: Christian Maiwald, Dr. +49707129-81418 fioc@med.uni-tuebingen.de
Contact: Center for pediatric clinical trials (CPCS) Tuebingen +49707129-81469 CPCS@med.uni-tuebingen.de

Locations
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Germany
University Hospital Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Ulrich H Thome, Prof. Dr.       ulrich.thome@medizin.uni-leipzig.de   
University Hospital Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Axel R Franz, Prof. Dr.       axel.franz@med.uni-tuebingen.de   
Contact: Christian Maiwald, Dr.       christian.maiwald@med.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Study Director: Axel Franz, Prof. Dr. University Children’s Hospital Tuebingen

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03168516     History of Changes
Other Study ID Numbers: FiO2-C
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Tuebingen:
Oxygen
closed-loop automatic control
Oxygen saturation
preterm infants