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Enteral Nutrition Tolerance And REspiratory Support (ENTARES) (ENTARES)

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ClinicalTrials.gov Identifier: NCT03548324
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Francesco Cresi, MD, PhD, University of Turin, Italy

Brief Summary:

This research study aims to evaluate the relation between non-invasive ventilation and feeding tolerance in preterms with respiratory distress syndrome (RDS).

To this purpose a multicenter randomized controlled trial was designed. It will involve 13 neonatal intensive care units (NICUs) in Italy and will be coordinated by the NICU of the University of Turin.

The study focuses on the impact of two non-invasive respiratory support techniques (NCPAP and HHHFNC) on feeding intolerance and gastrointestinal complications to identify which technique is the most effective and safe in preterms with RDS. Further aim is to identify which technique could be the most suitable for full enteral feeding achievement and acquisition of oral feeding. Improving enteral feeding tolerance and promoting oral feeding could improve clinical outcomes and reduce risks and costs of prolonged hospital stay.

Further aim is to evaluate the response to NCPAP and HHHFNC in the treatment of RDS, focusing on a population of extremely low preterms.


Condition or disease Intervention/treatment Phase
Very Low Birth Weight Infant Respiratory Distress Syndrome in Premature Infant Enteral Feeding Intolerance Device: HHHFNC Device: NCPAP Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two arms multicenter randomized controlled trial designed according to the intention-to-treat model. The assignement to one of the two arms (NCPAP or HHHFNC) is by block randomization. The randomization program is designed to obtain, in each research unit, a balance between the two arms according to gestation age (GA <28 weeks and GA ≥ 28 weeks).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enteral Nutrition Tolerance and Non-invasive Respiratory Support in Preterm Infants
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020


Arm Intervention/treatment
Active Comparator: HHHFNC
Heated Humidified High Flow Nasal Cannulae
Device: HHHFNC
Application to HHHFNC to treat respiratory distress syndrome in preterm infants previously demonstrated to be stable on a non-invasive respiratory support (HHHFNC or NCPAP).

Active Comparator: NCPAP
Nasal Continuous Positive Air Pressure
Device: NCPAP
Application to NCPAP to treat respiratory distress syndrome in preterm infants previously demonstrated to be stable on a non-invasive respiratory support (HHHFNC or NCPAP).




Primary Outcome Measures :
  1. Full Enteral Feeding (FEF) time [ Time Frame: From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months ]
    Time to reach Full Enteral Feeding, defined as an enteral intake of 150 mL/kg/die (n. of days)


Secondary Outcome Measures :
  1. Half Enteral Feeding (HEF) time [ Time Frame: From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months ]
    Time to reach Full Enteral Feeding/2, defined as an enteral intake of 75 mL/kg/die (n. of days)

  2. Enteral feeding interruptions [ Time Frame: From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months ]
    Median number of feeding interruptions per day

  3. Not given feeds [ Time Frame: From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months ]
    Median number of not given feeds per day

  4. Pathologic gastric residuals [ Time Frame: From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months ]
    Median number of pathologic gastric residuals per day

  5. Vomits and/or regurgitations [ Time Frame: From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months ]
    Median number of vomits and/or regurgitations per day

  6. Abdominal distension [ Time Frame: From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months ]
    Median abdominal distension score per day

  7. Beginning of oral feeding [ Time Frame: From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months ]
    Post-menstrual age when bottle- or breast-feeding is started

  8. Full oral feeding time [ Time Frame: From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months ]
    Post-menstrual age when full bottle- or breast-feeding is achieved

  9. Weight growth [ Time Frame: From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months ]
    Weight growth evaluated through Δ z-score analysis

  10. Duration of respiratory support assigned at randomization [ Time Frame: From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months ]
    Time during which the non-invasive respiratory support device assigned at randomization is maintained

  11. Total duration of respiratory support need [ Time Frame: From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months ]
    Time during which any kind of respiratory support is needed

  12. Failure of the respiratory support assigned at randomization [ Time Frame: From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months ]
    Failure of the respiratory support assigned and need for mechanical ventilation or different kind of respiratory support (n. of days)

  13. Length of hospital stay [ Time Frame: From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months ]
    Total duration of hospital stay (n. of days)

  14. Complications [ Time Frame: From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months ]
    Occurrence of complications as NEC, bowel perforation, pneumothorax, BPD, retinopathy of the premature.



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Ages Eligible for Study:   25 Weeks to 29 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of RDS
  • stability on HHHFNC or NCPAP since at least 48 hours (SatO2 TC 90-95%, pCO2 ≤ 60 mmHg, FiO2 < 40%, Silverman score ≤ 6, ≤ 2 apnea episodes/hour with CPAP ≤ 7 cmH2O if on NCPAP and flow ≤ 6 L/min if on HHHFNC )
  • ≤ 7 days of life
  • suitability to start enteral feeding (if not already started)
  • parental written consent

Exclusion Criteria:

  • neurological or surgical diseases
  • sepsis
  • chromosomal abnormalities or major malformations

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): NCT03548324


Contacts
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Contact: Francesco Cresi, MD, PhD +390113134437 francesco.cresi@unito.it
Contact: Silvia Borgione, MD +390113134437 silvia.borgione@unito.it

Locations
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Italy
AOUC Policlinico di Bari Recruiting
Bari, Bari (BA), Italy
Contact: Nicola Laforgia       nicola.laforgia@uniba.it   
Principal Investigator: Nicola Laforgia         
Sub-Investigator: Antonio Di Mauro         
Sub-Investigator: Maria E Baldassarre         
ASL Ospedale Di Venere Not yet recruiting
Bari, Bari (BA), Italy
Contact: Antonio Del Vecchio       delveccant@libero.it   
Principal Investigator: Antonio Del Vecchio         
Sub-Investigator: Flavia Petrillo         
Sub-Investigator: Maria P Spalierno         
Ospedale Maggiore - AUSL di Bologna Not yet recruiting
Bologna, Bologna (BO), Italy
Contact: Fabrizio Sandri       f.sandri@ausl.bologna.it   
Principal Investigator: Fabrizio Sandri         
Sub-Investigator: Roksana Chakrokh         
Policlinico S. Orsola - Malpighi Not yet recruiting
Bologna, Bologna (BO), Italy
Contact: Luigi T Corvaglia       luigi.corvaglia@unibo.it   
Principal Investigator: Luigi T Corvaglia         
Sub-Investigator: Arianna Aceti         
AOU Careggi Not yet recruiting
Firenze, Firenze (FI), Italy
Contact: Carlo Dani       carlo.dani@unifi.it   
Principal Investigator: Carlo Dani         
Sub-Investigator: Serena Elia         
ASST Grande Ospedale Metropolitano Niguarda Recruiting
Milano, Milano (MI), Italy
Contact: Stefano Martinelli       stefano.martinelli@ospedaleniguarda.it   
Principal Investigator: Laura Ilardi         
Sub-Investigator: Alice Proto         
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Mangiagalli) Recruiting
Milano, Milano (MI), Italy
Contact: Fabio Mosca       fabio.mosca@mangiagalli.it   
Principal Investigator: Fabio Mosca         
Sub-Investigator: Anna Orsi         
Sub-Investigator: Domenica Mercadante         
Ospedale dei Bambini Vittore Buzzi Recruiting
Milano, MI, Italy
Contact: Gianluca Lista       gianluca.lista@asst-fbf-sacco.it   
Principal Investigator: Gianluca Lista         
Sub-Investigator: Fabio Meneghin         
AOU Federico II Recruiting
Napoli, Napoli (NA), Italy
Contact: Francesco Raimondi       raimondi@unina.it   
Principal Investigator: Francesco Raimondi         
Sub-Investigator: Letizia Capasso         
Fondazione Policlinico Universitario A. Gemelli Not yet recruiting
Roma, Roma (RM), Italy
Contact: Giovanni Vento       giovanni.vento@policlinicogemelli.it   
Principal Investigator: Luca Maggio         
AOU Città della Salute e della Scienza di Torino - Ospedale S.Anna Recruiting
Torino, Torino (TO), Italy
Contact: Daniele Farina       dfarina@cittadellasalute.to.it   
Principal Investigator: Maria F Campagnoli         
Sub-Investigator: Tatiana Boetti         
AOU Città della Salute e della Scienza di Torino - Ospedale S.Anna Recruiting
Torino, TO, Italy, 10126
Contact: Enrico Bertino    +39113135775    enrico.bertino@unito.it   
Principal Investigator: Francesco Cresi         
Sub-Investigator: Silvia Borgione         
Sub-Investigator: Elena Maggiora         
Sub-Investigator: Elena Spada         
ASST Sette Laghi Polo Universitario Not yet recruiting
Varese, Varese (VA), Italy
Contact: Massimo Agosti       massimo.agosti@asst-settelaghi.it   
Principal Investigator: Massimo Agosti         
Sub-Investigator: Laura Morlacchi         
Sub-Investigator: Simona Perniciaro         
Sponsors and Collaborators
University of Turin, Italy
Investigators
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Study Director: Francesco Cresi, MD, PhD Città della Salute e della Scienza, S.C. Neonatologia U., University of Turin

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Francesco Cresi, MD, PhD, Principal Investigator, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT03548324     History of Changes
Other Study ID Numbers: ENTARES
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Francesco Cresi, MD, PhD, University of Turin, Italy:
Feeding Tolerance
RDS
HFNC
NCPAP
Preterm
NEC
Enteral Nutrition
Non Invasive Respiratory Support
Very Low Birth Weight Infant

Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Birth Weight
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Body Weight
Signs and Symptoms