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Optimal Settings of Non Invasive Respiratory Support in Preterm Newborns

Choice and Optimal Settings of Non Invasive Respiratory Support in Preterm Newborns < 30 Gestational Weeks

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03592134
Enrollment
60
Registered
2018-07-19
Start date
2018-02-22
Completion date
2018-11-09
Last updated
2018-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infant, Respiratory Distress Syndrome

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.

Interventions

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

Sponsors

Hôpital Necker-Enfants Malades
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Weeks to 6 Weeks

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

Design outcomes

Primary

MeasureTime frameDescription
Maximal variation of esophageal pressureat participant inclusion day 1Maximal variation of esophageal pressure will be compared for the different respiratory supports and the different settings

Secondary

MeasureTime frameDescription
occurrence of bronchopulmonary dysplasia at 36 Gestational age (GA)From 2 to 7 weeks after participant's inclusion (day 1)
need for nutritional supportFrom 2 to 7 weeks after participant's inclusion (day 1)
definitive weaning delayFrom 2 to 7 weeks after participant's inclusion (day 1)weaning from noninvasive respiratory support and oxygen supplementation

Countries

France

Contacts

Primary ContactBrigitte Fauroux, MD, PhD
brigitte.fauroux@aphp.fr+33144496092
Backup ContactSonia Khirani, PhD
sonia_khirani@yahoo.fr+33144494091

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026