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Optimal Settings of Non Invasive Respiratory Support in Preterm Newborns

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ClinicalTrials.gov Identifier: NCT03592134
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Brigitte Fauroux, Hôpital Necker-Enfants Malades

Brief Summary:
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.

Condition or disease Intervention/treatment
Preterm Infant Respiratory Distress Syndrome Other: esophageal pressure measurement

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Choice and Optimal Settings of Non Invasive Respiratory Support in Preterm Newborns < 30 Gestational Weeks
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : September 21, 2018
Estimated Study Completion Date : November 9, 2018


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
Other: esophageal pressure measurement
Measurement of esophageal pressure to determine the optimal non invasive respiratory support




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. occurrence of bronchopulmonary dysplasia at 36 Gestational age (GA) [ Time Frame: From 2 to 7 weeks after participant's inclusion (day 1) ]
  2. need for nutritional support [ Time Frame: From 2 to 7 weeks after participant's inclusion (day 1) ]
  3. definitive weaning delay [ Time Frame: From 2 to 7 weeks after participant's inclusion (day 1) ]
    weaning from noninvasive respiratory support and oxygen supplementation



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Ages Eligible for Study:   up to 6 Weeks   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Preterm infants needing a non invasive respiratory support after 4 weeks of life
Criteria

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

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): NCT03592134


Contacts
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Contact: Brigitte Fauroux, MD, PhD +33144496092 brigitte.fauroux@aphp.fr
Contact: Sonia Khirani, PhD +33144494091 sonia_khirani@yahoo.fr

Locations
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France
AP-HP Hopital Necker Recruiting
Paris, France, 75015
Contact: Brigitte Fauroux, MD, PhD    +33144496092    brigitte.fauroux@aphp.fr   
Sponsors and Collaborators
Hôpital Necker-Enfants Malades
Investigators
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Principal Investigator: Brigitte Fauroux, MD, PhD AP-HP Hopital Necker

Publications of Results:
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Responsible Party: Brigitte Fauroux, Professor, Hôpital Necker-Enfants Malades
ClinicalTrials.gov Identifier: NCT03592134     History of Changes
Other Study ID Numbers: 2017-A00535-48
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Tract Diseases
Infant, Newborn, Diseases
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases