ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 3 for:    18272893 [PUBMED-IDS]

nHFOV vs nCPAP: Effects on Gas Exchange for the Treatment of Neonates Recovering From RDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02772835
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : February 27, 2018
Sponsor:
Collaborators:
Policlinico Universitario Agostino Gemelli
Ospedali Riuniti di Foggia
Vittore Buzzi Children's Hospital
Vilnius University
Hospital San Pietro Fatebenefratelli
Ospedale F. Del Ponte, Varese
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Information provided by (Responsible Party):
Fondazione Poliambulanza Istituto Ospedaliero

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Preterm Birth Device: Medin-cno Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nasal HFOV vs Nasal CPAP: Effects on Gas Exchange for the Treatment of Neonates Recovering From Respiratory Distress Syndrome. A Multicenter Randomized Controlled Trial
Study Start Date : January 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2017


Arm Intervention/treatment
Active Comparator: nHFOV
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
Medin-cno is a noninvasive ventilator. With this device we can practice either nCPAP and nHFOV ventilation.
Other Names:
  • nHFOV
  • nCPAP
Active Comparator: nCPAP
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
Medin-cno is a noninvasive ventilator. With this device we can practice either nCPAP and nHFOV ventilation.
Other Names:
  • nHFOV
  • nCPAP



Primary Outcome Measures :
  1. Comparison between nHFOV and nCPAP on gas exchange in premature infants with persistent oxygen need recovering from RDS, particularly on CO2 removal. [ Time Frame: 4 hours ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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): NCT02772835


Locations
Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy, 25124
Ospedali Riuniti di Foggia
Foggia, Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milano, Italy
Vittore Buzzi Children's Hospital
Milano, Italy
Hospital San Pietro Fatebenefratelli
Roma, Italy
Policlinico Universitario Agostino Gemelli
Roma, Italy
Ospedale F. Del Ponte
Varese, Italy
Lithuania
Vilnius University
Vilnius, Lithuania
Sponsors and Collaborators
Fondazione Poliambulanza Istituto Ospedaliero
Policlinico Universitario Agostino Gemelli
Ospedali Riuniti di Foggia
Vittore Buzzi Children's Hospital
Vilnius University
Hospital San Pietro Fatebenefratelli
Ospedale F. Del Ponte, Varese
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
Principal Investigator: Roberto Bottino, Doctor Fondazione Poliambulanza Istituto Ospedaliero
Study Chair: Giovanni Vento, Doctor Policlinico Universitario Agostino Gemelli
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

Publications:

Responsible Party: Fondazione Poliambulanza Istituto Ospedaliero
ClinicalTrials.gov Identifier: NCT02772835     History of Changes
Other Study ID Numbers: NHVSNC
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Fondazione Poliambulanza Istituto Ospedaliero:
nCPAP
nHFOV
Preterm
RDS
CO2 Elimination

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Premature Birth
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications