- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03592134
Optimal Settings of Non Invasive Respiratory Support in Preterm Newborns
July 17, 2018 updated by: Brigitte Fauroux, Hôpital Necker-Enfants Malades
Choice and Optimal Settings of Non Invasive Respiratory Support in Preterm Newborns < 30 Gestational Weeks
Noninvasive respiratory supports (NRS), such as continuous positive airway pressure (CPAP), noninvasive ventilation, high flow nasal cannula (HFNC) or nasal oxygen (O2), are commonly used in preterm newborns hospitalized in neonatal intensive care unit.
However, given the lack of validated criteria, clinicians usually choose the NRS according to clinical parameters and patients' comfort.
Several studies have demonstrated the interest of the measurement of the work of breathing (WOB) to optimize the settings of NRS in children, but no study has already demonstrated the utility of WOB to optimize the settings of NRS in preterm infants.
Therefore, the aim of this study is to measure the WOB during the utilisation of three different NRS (CPAP, HFNC, O2), in order to optimize the choice of the type and settings of NRS in a randomized group of 30 newborns born prematurely before 30 gestational weeks and still requiring NRS at 29 post conceptual weeks.
Moreover, the investigators will compare in the newborns with the optimized NRS by WOB vs. a standard care control group (NRS type and settings determined as clinical routine): 1) the respiratory morbidity and mortality one month after the initial assessment, and at the time of hospital discharge (or transfer) or at 36 weeks of age corrected (whatever comes first), 2) the weaning time of the NRS, 3) the incidence and severity of broncho-pulmonary dysplasia (BPD) at 36 weeks of age corrected.
Indeed, incidence of BPD is still around 40% in premature infants born before 28 gestational weeks.
The hypothesis of the investigators' study is that the optimization of the type and settings of the NRS could reduce the weaning delay and contribute to reduce the incidence and severity of BPD in premature newborns.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Brigitte Fauroux, MD, PhD
- Phone Number: +33144496092
- Email: brigitte.fauroux@aphp.fr
Study Contact Backup
- Name: Sonia Khirani, PhD
- Phone Number: +33144494091
- Email: sonia_khirani@yahoo.fr
Study Locations
-
-
-
Paris, France, 75015
- Recruiting
- AP-HP Hôpital Necker
-
Contact:
- Brigitte Fauroux, MD, PhD
- Phone Number: +33144496092
- Email: brigitte.fauroux@aphp.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 weeks to 1 month (CHILD)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Preterm infants needing a non invasive respiratory support after 4 weeks of life
Description
Inclusion Criteria:
- Preterm infants born between 23 and 30 GA
- Aged over 29 weeks of corrected age at the time of assessment and needing a non invasive respiratory support since at least 4 weeks of age
Exclusion Criteria:
- Hemodynamic and/or neurologic instability
- Invasive ventilation
- Congenital cardiopathy and/or significant patent ductus arteriosus
- Sedation
- Congenital pulmonary disease and/or other malformations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Clinical settings
Infants with the choice of the non respiratory support and settings of the non respiratory support defined by clinical practice (nocturnal gas exchange, apneas, bradycardia, oxygen desaturation)
|
|
Physiological settings
Infants with the choice of the non respiratory support and settings of the non respiratory support defined by the measurement of work of breathing
|
Measurement of esophageal pressure to determine the optimal non invasive respiratory support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal variation of esophageal pressure
Time Frame: at participant inclusion day 1
|
Maximal variation of esophageal pressure will be compared for the different respiratory supports and the different settings
|
at participant inclusion day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
occurrence of bronchopulmonary dysplasia at 36 Gestational age (GA)
Time Frame: From 2 to 7 weeks after participant's inclusion (day 1)
|
From 2 to 7 weeks after participant's inclusion (day 1)
|
|
need for nutritional support
Time Frame: From 2 to 7 weeks after participant's inclusion (day 1)
|
From 2 to 7 weeks after participant's inclusion (day 1)
|
|
definitive weaning delay
Time Frame: From 2 to 7 weeks after participant's inclusion (day 1)
|
weaning from noninvasive respiratory support and oxygen supplementation
|
From 2 to 7 weeks after participant's inclusion (day 1)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brigitte Fauroux, MD, PhD, AP-HP Hôpital Necker
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Liptsen E, Aghai ZH, Pyon KH, Saslow JG, Nakhla T, Long J, Steele AM, Habib RH, Courtney SE. Work of breathing during nasal continuous positive airway pressure in preterm infants: a comparison of bubble vs variable-flow devices. J Perinatol. 2005 Jul;25(7):453-8. doi: 10.1038/sj.jp.7211325.
- Shetty S, Hickey A, Rafferty GF, Peacock JL, Greenough A. Work of breathing during CPAP and heated humidified high-flow nasal cannula. Arch Dis Child Fetal Neonatal Ed. 2016 Sep;101(5):F404-7. doi: 10.1136/archdischild-2015-309310. Epub 2016 Jan 14.
- de Jongh BE, Locke R, Mackley A, Emberger J, Bostick D, Stefano J, Rodriguez E, Shaffer TH. Work of breathing indices in infants with respiratory insufficiency receiving high-flow nasal cannula and nasal continuous positive airway pressure. J Perinatol. 2014 Jan;34(1):27-32. doi: 10.1038/jp.2013.120. Epub 2013 Sep 26.
- Saslow JG, Aghai ZH, Nakhla TA, Hart JJ, Lawrysh R, Stahl GE, Pyon KH. Work of breathing using high-flow nasal cannula in preterm infants. J Perinatol. 2006 Aug;26(8):476-80. doi: 10.1038/sj.jp.7211530. Epub 2006 May 11.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 22, 2018
Primary Completion (Anticipated)
September 21, 2018
Study Completion (Anticipated)
November 9, 2018
Study Registration Dates
First Submitted
July 5, 2018
First Submitted That Met QC Criteria
July 17, 2018
First Posted (Actual)
July 19, 2018
Study Record Updates
Last Update Posted (Actual)
July 19, 2018
Last Update Submitted That Met QC Criteria
July 17, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-A00535-48
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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