NCT02772835

Brief Summary

The purpose of this study is to compare the effects of two different techniques of non-invasive ventilation (nCPAP and nHFOV) on gas exchange in preterm infants recovering from respiratory distress syndrome.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

May 3, 2016

Last Update Submit

February 26, 2018

Conditions

Respiratory Distress SyndromePreterm Birth

Keywords

nCPAPnHFOVPretermRDSCO2 Elimination

Outcome Measures

Primary Outcomes (1)

  • Comparison between nHFOV and nCPAP on gas exchange in premature infants with persistent oxygen need recovering from RDS, particularly on CO2 removal.

    Infants will be started on the randomized starting mode of either nCPAP or nHFOV: four 1 h study blocks, alternating from the initial mode to the alternate mode twice. During each study block, the following data will be recorded: TcPCO2, TcPO2, heart rate, respiratory rate, SaO2, Silverman score, cer-rSO2 and ren-rSO2. Manual blood pressure will be taken 30 minutes after the beginning of each treatment block. Immediately after entering the study, at the beginning of the first study period, a transcutaneous monitoring of TcPCO2 and TcPO2 will be started and a capillary BGA will be performed in order to test the reliability of the TcPCO2 data. A second capillary BGA will be performed at the end of second study period in both CPAP and nHFOV. To allow for equilibration, we will group and analyze data points from the last 20 min of each treatment block. All the data will be recorded continuously at 1-min intervals directly from the monitor and recorded on a respiratory sheet.

    4 hours

Study Arms (2)

nHFOV

ACTIVE COMPARATOR

Starting treatment mode: nHFOV with Medin-cno. Targeted oxygen saturation: 87-94%. Four 1 h study blocks, alternating from the initial mode to the alternate mode twice. All the data will be recorded at 1-min intervals. The following data will be recorded: tcPCO2, tcPO2, heart rate, respiratory rate, SaO2, Silverman score, cer-rSO2, ren-rSO2. Blood pressure will be taken 30 minutes after the beginning of each treatment block. At the beginning of the first period a BGA will be performed in order to test the reliability of the TcPCO2 data. A second capillary BGA will be performed at the end of second period.

Device: Medin-cno

nCPAP

ACTIVE COMPARATOR

Starting treatment mode: nCPAP with Medin-cno. Targeted oxygen saturation of 87-94%. Four 1 h study blocks, alternating from the initial mode to the alternate mode twice. All the data will be recorded at 1-min intervals. The following data will be recorded: tcPCO2, tcPO2, heart rate, respiratory rate, SaO2, Silverman score, cer-rSO2, ren-rSO2. Blood pressure will be taken 30 minutes after the beginning of each treatment block. At the be-ginning of the first period a BGA will be performed in order to test the reliability of the TcPCO2 data. A se-cond capillary BGA will be performed at the end of second period.

Device: Medin-cno

Interventions

Medin-cnoDEVICE

Medin-cno is a noninvasive ventilator. With this device we can practice either nCPAP and nHFOV ventilation.

Also known as: nHFOV, nCPAP
nCPAPnHFOV

Eligibility Criteria

Age7 Days - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Birthweight \< 1500g and/or
  • Gestational age \< 32 weeks
  • nCPAP treatment for \> 24 h
  • Oxygen supply to keep SaO2 87-94% for a minimum of 1 h prior to initiation of the study
  • Parents written informed consent

You may not qualify if:

  • Active medical treatment for patent ductus arteriosus
  • culture proven sepsis
  • Major congenital malformations
  • Genetic syndromes
  • Postoperative recovery period of \<24 h

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

Location

Ospedali Riuniti di Foggia

Foggia, Italy

Location

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, Italy

Location

Vittore Buzzi Children's Hospital

Milan, Italy

Location

Hospital San Pietro Fatebenefratelli

Roma, Italy

Location

Policlinico Universitario Agostino Gemelli

Roma, Italy

Location

Ospedale F. Del Ponte

Varese, Italy

Location

Vilnius University

Vilnius, Lithuania

Location

Related Publications (10)

  • Colaizy TT, Younis UM, Bell EF, Klein JM. Nasal high-frequency ventilation for premature infants. Acta Paediatr. 2008 Nov;97(11):1518-22. doi: 10.1111/j.1651-2227.2008.00900.x. Epub 2008 Jun 9.

    PMID: 18549418BACKGROUND

  • Carlo WA. Should nasal high-frequency ventilation be used in preterm infants? Acta Paediatr. 2008 Nov;97(11):1484-5. doi: 10.1111/j.1651-2227.2008.01016.x. Epub 2008 Aug 26. No abstract available.

    PMID: 18754830BACKGROUND

  • Kirpalani H, Millar D, Lemyre B, Yoder BA, Chiu A, Roberts RS; NIPPV Study Group. A trial comparing noninvasive ventilation strategies in preterm infants. N Engl J Med. 2013 Aug 15;369(7):611-20. doi: 10.1056/NEJMoa1214533.

    PMID: 23944299BACKGROUND

  • Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB; COIN Trial Investigators. Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med. 2008 Feb 14;358(7):700-8. doi: 10.1056/NEJMoa072788.

    PMID: 18272893BACKGROUND

  • Dunn MS, Kaempf J, de Klerk A, de Klerk R, Reilly M, Howard D, Ferrelli K, O'Conor J, Soll RF; Vermont Oxford Network DRM Study Group. Randomized trial comparing 3 approaches to the initial respiratory management of preterm neonates. Pediatrics. 2011 Nov;128(5):e1069-76. doi: 10.1542/peds.2010-3848. Epub 2011 Oct 24.

    PMID: 22025591BACKGROUND

  • Habre W. Neonatal ventilation. Best Pract Res Clin Anaesthesiol. 2010 Sep;24(3):353-64. doi: 10.1016/j.bpa.2010.02.020.

    PMID: 21033012BACKGROUND

  • Sivieri EM, Gerdes JS, Abbasi S. Effect of HFNC flow rate, cannula size, and nares diameter on generated airway pressures: an in vitro study. Pediatr Pulmonol. 2013 May;48(5):506-14. doi: 10.1002/ppul.22636. Epub 2012 Jul 23.

    PMID: 22825878BACKGROUND

  • Sola A, Golombek SG, Montes Bueno MT, Lemus-Varela L, Zuluaga C, Dominguez F, Baquero H, Young Sarmiento AE, Natta D, Rodriguez Perez JM, Deulofeut R, Quiroga A, Flores GL, Morgues M, Perez AG, Van Overmeire B, van Bel F. Safe oxygen saturation targeting and monitoring in preterm infants: can we avoid hypoxia and hyperoxia? Acta Paediatr. 2014 Oct;103(10):1009-18. doi: 10.1111/apa.12692. Epub 2014 Jul 28.

    PMID: 24838096BACKGROUND

  • Lampland AL, Plumm B, Worwa C, Meyers P, Mammel MC. Bi-level CPAP does not improve gas exchange when compared with conventional CPAP for the treatment of neonates recovering from respiratory distress syndrome. Arch Dis Child Fetal Neonatal Ed. 2015 Jan;100(1):F31-4. doi: 10.1136/fetalneonatal-2013-305665. Epub 2014 Aug 1.

    PMID: 25085943BACKGROUND

  • van der Hoeven M, Brouwer E, Blanco CE. Nasal high frequency ventilation in neonates with moderate respiratory insufficiency. Arch Dis Child Fetal Neonatal Ed. 1998 Jul;79(1):F61-3. doi: 10.1136/fn.79.1.f61.

    PMID: 9797628BACKGROUND

MeSH Terms

Conditions

Respiratory Distress SyndromePremature Birth

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Roberto Bottino, Doctor

    Fondazione Poliambulanza Istituto Ospedaliero

    PRINCIPAL INVESTIGATOR

  • Giovanni Vento, Doctor

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    STUDY CHAIR

  • Gianfranco Maffei, Doctor

    Ospedali Riuniti di Foggia

    STUDY CHAIR

  • Gianluca Lista, Doctor

    Vittore Buzzi Children's Hospital

    STUDY CHAIR

  • Vladimiras Chijenas, Doctor

    Vilnius University

    STUDY CHAIR

  • Arunas Liubsys, Doctor

    Vilnius University

    STUDY CHAIR

  • Chiara Consigli, Doctor

    Hospital San Pietro Fatebenefratelli

    STUDY CHAIR

  • Massimo Agosti, Doctor

    Ospedale F. Del Ponte, Varese

    STUDY CHAIR

  • Mariarosa Colnaghi, Doctor

    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 16, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

IT(7)LI(1)