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Trial record 1 of 1 for:    NCT02482766
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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 : Completed
First Posted : June 26, 2015
Last Update Posted : February 15, 2019
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

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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 30, 2018


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


Locations
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Italy
Ospedale Salesi
Ancona, AN, Italy
Ospedale Di Venere
Bari, BA, Italy
Ospedale Maggiore
Bologna, BO, Italy
Fondazione Poliambulanza
Brescia, BS, Italy
Ospedale di Bolzano
Bolzano, BZ, Italy
Pineta Grande
Caserta, CE, Italy, 81030
S. Sebastiano e S. Anna
Caserta, CE, Italy
Azienda Ospedaliera di Cosenza
Cosenza, CS, Italy
AOU Policlinico Vittorio Emanuele- Presidio Ospedaliero Gaspare Rodolico
Catania, CT, Italy
Ospedale Nuovo Garibaldi-Nesima
Catania, CT, Italy
Ospedale Vito Fazzi
Lecce, LE, Italy, 73100
Ospedale Barone Romeo
Patti, ME, Italy
Ospedale san Pietro Fatebenefratelli
Rome, RM, Italy, 00100
Ospedale San Bortolo
Vicenza, VI, Italy, 36100
SS Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Azienda Ospedaliera Universitaria Ferrara
Ferrara, Italy
Careggi
Firenze, Italy
Ospedali Riuniti
Foggia, Italy
Ospedale San Salvatore
L'Aquila, Italy
Carlo Poma
Mantova, Italy
Università degli studi di Messina A.O.U. Policlinico G. Martino
Messina, Italy
Mangiagalli
Milano, Italy
Ospedale Niguarda
Milano, Italy
A.O.U. di Modena Policlinico
Modena, Italy
S. Gerardo
Monza, Italy
Ospedale Maggiore
Novara, Italy
Arnas Civico di Palermo
Palermo, Italy
A.O. Bianchi-Melacrino-Morelli
Reggio Calabria, Italy
Arcispedale Santa Maria Nuova
Reggio nell'Emilia, Italy
Fatebenefratelli-Isola Tiberina
Roma, Italy
Policlinico Gemelli-Università Cattolica S. Cuore
Rome, Italy, 00168
A.O. Treviso Ospedale Cà Foncello
Treviso, Italy
Belcolle
Viterbo, Italy
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
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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):
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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: February 15, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Hyaline Membrane Disease
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Poractant alfa
Respiratory System Agents