Optimal Settings of Non Invasive Respiratory Support in Preterm Newborns

Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03592134
• Other study ID #: 2017-A00535-48
• Status: Recruiting
• Start date: February 22, 2018
• Est. completion date: November 9, 2018

Study information

• Verified date: July 2018
• Source: Hôpital Necker-Enfants Malades
• Contact: Brigitte Fauroux, MD, PhD
• Phone: +33144496092
• Email: brigitte.fauroux[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 9, 2018
• Est. primary completion date: September 21, 2018
• Gender: All
• Age group: N/A to 6 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
France	AP-HP Hopital Necker	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Necker-Enfants Malades

Country where clinical trial is conducted

France, 

References & Publications (4)

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. 2 — View Citation

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 — View Citation

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. Epub 2006 May 11. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal variation of esophageal pressure	Maximal variation of esophageal pressure will be compared for the different respiratory supports and the different settings	at participant inclusion day 1
Secondary	occurrence of bronchopulmonary dysplasia at 36 Gestational age (GA)		From 2 to 7 weeks after participant's inclusion (day 1)
Secondary	need for nutritional support		From 2 to 7 weeks after participant's inclusion (day 1)
Secondary	definitive weaning delay	weaning from noninvasive respiratory support and oxygen supplementation	From 2 to 7 weeks after participant's inclusion (day 1)