Optimal Settings of Non Invasive Respiratory Support in Preterm Newborns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-22

Study Completion Date

2018-11-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Preterm Infant Respiratory Distress Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

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

esophageal pressure measurement

Intervention Type OTHER

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

Interventions

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esophageal pressure measurement

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

4 Weeks

Maximum Eligible Age

6 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No