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Efficacy of a New Technique -"IN-REC-SUR-E"- in Preterm Neonates With RDS

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ClinicalTrials.gov Identifier: NCT02482766
Recruitment Status : Recruiting
First Posted : June 26, 2015
Last Update Posted : April 10, 2017
Sponsor:
Collaborators:
Ospedali Riuniti Ancona
Ospedale Careggi, Florence, Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Centre for Neonatal Research and Education, Crawley, West Australia
Monash University
Azienda Ospedaliera San Gerardo di Monza
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
Giovanni VENTO, Catholic University of the Sacred Heart

Brief Summary:
The primary hypothesis of this study is reduction in need of mechanical ventilation in the first 72 hours of life (excluding the transient tracheal intubation performed for surfactant administration and the mechanical ventilation for lung recruitment) in spontaneously breathing infants born at 24+0-27+6 weeks' gestation and failing nCPAP during the first 24 hours of life who received an HFOV recruitment maneuver (IN-REC-SUR-E) compared to no recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt extubation.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Hyaline Membrane Disease Drug: Poractant alfa, 200 mg/kg Device: Ventilator for High-frequency Oscillatory Ventilation (HFOV) Device: Nasal Continuous Positive Airway Pressure (nCPAP) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of a New Technique -"IN-REC-SUR-E"- in Preterm Neonates With Respiratory Distress Syndrome During Non Invasive Ventilation: a Randomized Controlled Trial
Study Start Date : November 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: INRECSURE
Infants in the INRECSURE arm will undergo the following approach: as soon as possible after the recruitment manoeuver (at CDP-Optimal) a dose of poractant alfa (Curosurf [Chiesi Farmaceutici, Parma, Italy]) of 200 mg/kg will be administered via a closed administration system in one-two aliquots (1-2 minutes). The tube position will be confirmed by auscultation. A temporary reduction of frequency may be necessary to increase the VT up to 2.5 ml/kg for improving the surfactant spreading.
Drug: Poractant alfa, 200 mg/kg
Endotracheal Surfactant administration
Other Name: Curosurf-Chiesi Farmaceutici, Parma, Italy

Device: Ventilator for High-frequency Oscillatory Ventilation (HFOV)
This device will be used to perform an HFOV recruitment maneuver before surfactant administration

Device: Nasal Continuous Positive Airway Pressure (nCPAP)
After surfactant administration, the babies will be extubated within 30 minutes and will receive nCPAP (6-8 cm H2O)

Active Comparator: INSURE
Infants in the INSURE arm will undergo the following approach: after intubation, a dose of poractant alfa (Curosurf [Chiesi Farmaceutici, Parma, Italy]) of 200 mg/kg will be administered via a closed administration system in one-two aliquots (1-2 minutes). The tube position will be confirmed by auscultation. During surfactant administration, infants will be manually ventilated to facilitate surfactant distribution.
Drug: Poractant alfa, 200 mg/kg
Endotracheal Surfactant administration
Other Name: Curosurf-Chiesi Farmaceutici, Parma, Italy

Device: Nasal Continuous Positive Airway Pressure (nCPAP)
After surfactant administration, the babies will be extubated within 30 minutes and will receive nCPAP (6-8 cm H2O)




Primary Outcome Measures :
  1. Need for mechanical ventilation within the first 3 days of life and therefore we consider IN-REC-SUR-E a success if mechanical ventilation is not required and a failure if the infant needs mechanical ventilation in the first 72 hours. [ Time Frame: First 72 hours of life ]

Secondary Outcome Measures :
  1. Duration of NCPAP [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  2. Duration of conventional mechanical ventilation [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  3. Duration of High-frequency oscillatory ventilation (HFOV) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  4. Duration of O2-therapy [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  5. Duration of hospitalization [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  6. Number of doses of surfactant [ Time Frame: First 72 hours of life ]
  7. Occurrence of BPD (mild, moderate and severe forms) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  8. Time to be out of any respiratory support [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]

Other Outcome Measures:
  1. Air leaks [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
    "Mono or bilateral pneumothorax" ; "Pulmonary interstitial Emphysema"

  2. Pulmonary hemorrage [ Time Frame: First 72 hours of life ]
    Sudden onset of overt bleeding or frank evidence of blood in the airway, leading to acute respiratory distress or respiratory failure, with diffuse, bilateral pulmonary infiltrates on chest radiograph.

  3. PDA and need of surgical closure [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  4. Hour(s) of administration of surfactant dose(s) [ Time Frame: First 72 hours of life ]
  5. 3°- 4° IVH [ Time Frame: First week of life ]
  6. PVL [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  7. >2° ROP [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  8. NEC [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  9. Sepsis [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
    Sepsis is defined as a positive blood culture or suggestive clinical and laboratory findings leading to treatment with antibiotics for at least 7 days despite absence of a positive blood culture.

  10. Lenght of stay in NICU [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  11. Use of systemic postnatal steroids [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
    Number of cycles of postnatal steroids i.v.: "None", "1", "> 1 cycle"

  12. Mortality [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]


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Ages Eligible for Study:   24 Weeks to 27 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. In-Born at 24+0-27+6 (and)
  2. Spontaneously breathing at birth but requiring respiratory support (CPAP or O2) at 5' of life (and)
  3. Parental consent has been obtained (and)
  4. Failing nCPAP during the first 24 hours of life

Exclusion Criteria:

  1. Severe birth asphyxia or a 5-minute Apgar score <3
  2. Endotracheal intubation in the delivery room for resuscitation or insufficient respiratory drive according to AAP guidelines16
  3. Prolonged PROM > 3 weeks
  4. Presence of major congenital malformations
  5. Hydrops fetalis
  6. Inherited disorders of metabolism

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): NCT02482766


Contacts
Contact: Giovanni Vento, MD ++39-0630151 ext 4357 giovanni.vento@unicatt.it
Contact: Roberta Pastorino, PhD ++39-0630151 ext 4396 roberta.pastorino@gmail.com

Locations
Italy
Ospedale Salesi Recruiting
Ancona, AN, Italy
Contact: Stefano Nobile, MD       stefano.nobile@ospedaliriuniti.marche.it   
Ospedale Di Venere Recruiting
Bari, BA, Italy
Contact: Flavia Petrillo, MD       flavia.age@hotmail.it   
Ospedale Maggiore Recruiting
Bologna, BO, Italy
Contact: Fabrizio Sandri, MD       fabrizio.sandri@yahoo.it   
Fondazione Poliambulanza Recruiting
Brescia, BS, Italy
Contact: Roberto Bottino, MD       roberto.bottino@poliambulanza.it   
Ospedale di Bolzano Recruiting
Bolzano, BZ, Italy
Contact: Hubert Messner, MD       HUBERT.MESSNER@sabes.it   
Pineta Grande Recruiting
Caserta, CE, Italy, 81030
Contact: Enza Roma, M.D.       enzaroma@yahoo.it   
S. Sebastiano e S. Anna Recruiting
Caserta, CE, Italy
Contact: Carolina Grassia, MD       carolina.grassia@aorncaserta.it   
Azienda Ospedaliera di Cosenza Recruiting
Cosenza, CS, Italy
Contact: Gabriella Nigro, MD       gabriellanigro@virgilio.it   
AOU Policlinico Vittorio Emanuele- Presidio Ospedaliero Gaspare Rodolico Recruiting
Catania, CT, Italy
Contact: Betta Pasqua       mlbetta@yahoo.it   
Ospedale Nuovo Garibaldi-Nesima Recruiting
Catania, CT, Italy
Contact: Angela Motta, MD       fgangelamotta@gmail.com   
Ospedale Vito Fazzi Recruiting
Lecce, LE, Italy, 73100
Contact: Roberto Perniola, M.D.       rperniola@hotmail.com   
Ospedale Barone Romeo Recruiting
Patti, ME, Italy
Contact: Valerio Meli, MD       valemeil@hotmail.com   
Ospedale san Pietro Fatebenefratelli Recruiting
Rome, RM, Italy, 00100
Contact: Chiara Consigli, M.D.       chiaraconsigli@yahoo.it   
Ospedale San Bortolo Recruiting
Vicenza, VI, Italy, 36100
Contact: Stefania Vedovato, M.D.       stefaniavedovato78@gmail.com   
SS Antonio e Biagio e Cesare Arrigo Recruiting
Alessandria, Italy
Contact: Diego Gazzolo, MD       dgazzolo@hotmail.com   
Azienda Ospedaliera Universitaria Ferrara Recruiting
Ferrara, Italy
Contact: Giampaolo Garani, MD       gri@unife.it   
Careggi Recruiting
Firenze, Italy
Contact: Carlo Dani, MD       carlo.dani@unifi.it   
Ospedali Riuniti Recruiting
Foggia, Italy
Contact: Gianfranco Maffei, MD       gfmaffei@tiscali.it   
Ospedale San Salvatore Recruiting
L'Aquila, Italy
Contact: Sandra di Fabio, MD       sandra.difabio@virgilio.it   
Carlo Poma Recruiting
Mantova, Italy
Contact: Francesca Fusco, MD       francescapaola.fusco@aopoma.it   
Università degli studi di Messina A.O.U. Policlinico G. Martino Recruiting
Messina, Italy
Contact: Eloisa Gitto, MD       egitto@unime.it   
Mangiagalli Recruiting
Milano, Italy
Contact: Fabio Mosca, MD       fabio.mosca@mangiagalli.it   
Ospedale Niguarda Recruiting
Milano, Italy
Contact: Stefano Martinelli, MD       stefano.martinelli@ospedaleniguarda.it   
A.O.U. di Modena Policlinico Recruiting
Modena, Italy
Contact: Alberto Berardi, MD       berardi.alberto@policlinico.mo.it   
S. Gerardo Recruiting
Monza, Italy
Contact: Maria L Ventura, MD       mlois.ventura@gmail.com   
Ospedale Maggiore Recruiting
Novara, Italy
Contact: Federica Ferrero, MD       federica.ferrero@maggioreosp.novara.it   
Arnas Civico di Palermo Recruiting
Palermo, Italy
Contact: Lina Li Puma, MD       linalipuma@yahoo.it   
A.O. Bianchi-Melacrino-Morelli Recruiting
Reggio Calabria, Italy
Contact: Isabella Mondello, MD       isamond@virgilio.it   
Arcispedale Santa Maria Nuova Recruiting
Reggio nell'Emilia, Italy
Contact: Giancarlo Gargano, MD       giancarlo.gargano@asmn.re.it   
Fatebenefratelli-Isola Tiberina Recruiting
Roma, Italy
Contact: Camilla Gizzi, MD       camillagizzi@tin.it   
Policlinico Gemelli-Università Cattolica S. Cuore Recruiting
Rome, Italy, 00168
Contact: Giovanni Vento, MD    ++39-3287345418    giovanni.vento@unicatt.it   
A.O. Treviso Ospedale Cà Foncello Recruiting
Treviso, Italy
Contact: Francesca Tormena, MD       ftormena@ulss.tv.it   
Belcolle Recruiting
Viterbo, Italy
Contact: Alessandra Casati, MD       alessandra.casatigm@libero.it   
Sponsors and Collaborators
Catholic University of the Sacred Heart
Ospedali Riuniti Ancona
Ospedale Careggi, Florence, Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Centre for Neonatal Research and Education, Crawley, West Australia
Monash University
Azienda Ospedaliera San Gerardo di Monza
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: Giovanni Vento, MD Catholic University of the Sacred Heart

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Giovanni VENTO, Associate Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02482766     History of Changes
Other Study ID Numbers: Prot. rs 25882/14
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Hyaline Membrane Disease
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Poractant alfa
Respiratory System Agents