Very Low Birth Weight Infant Clinical Trial
— ENTARESOfficial title:
Enteral Nutrition Tolerance and Non-invasive Respiratory Support in Preterm Infants
Verified date | August 2022 |
Source | University of Turin, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 280 |
Est. completion date | October 30, 2021 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Weeks to 29 Weeks |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | AOUC Policlinico di Bari | Bari | Bari (BA) |
Italy | ASL Ospedale Di Venere | Bari | Bari (BA) |
Italy | Ospedale Sana Croce e Carle | Cuneo | CN |
Italy | AOU Careggi | Firenze | Firenze (FI) |
Italy | ASST Grande Ospedale Metropolitano Niguarda | Milano | Milano (MI) |
Italy | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Mangiagalli) | Milano | Milano (MI) |
Italy | Ospedale dei Bambini Vittore Buzzi | Milano | MI |
Italy | AOU Federico II | Napoli | Napoli (NA) |
Italy | Ospedale San Matteo | Pavia | PV |
Italy | Fondazione Policlinico Universitario A. Gemelli | Roma | Roma (RM) |
Italy | AOU Città della Salute e della Scienza di Torino - Ospedale S.Anna | Torino | Torino (TO) |
Italy | AOU Città della Salute e della Scienza di Torino - Ospedale S.Anna | Torino | TO |
Italy | ASST Sette Laghi Polo Universitario | Varese | Varese (VA) |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy |
Italy,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Full Enteral Feeding (FEF) time | Time to reach Full Enteral Feeding, defined as an enteral intake of 150 mL/kg/die (n. of days) | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months | |
Secondary | Half Enteral Feeding (HEF) time | Time to reach Full Enteral Feeding/2, defined as an enteral intake of 75 mL/kg/die (n. of days) | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months | |
Secondary | Enteral feeding interruptions | Median number of feeding interruptions per day | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months | |
Secondary | Not given feeds | Median number of not given feeds per day | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months | |
Secondary | Pathologic gastric residuals | Median number of pathologic gastric residuals per day | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months | |
Secondary | Vomits and/or regurgitations | Median number of vomits and/or regurgitations per day | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months | |
Secondary | Abdominal distension | Median abdominal distension score per day | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months | |
Secondary | Beginning of oral feeding | Post-menstrual age when bottle- or breast-feeding is started | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months | |
Secondary | Full oral feeding time | Post-menstrual age when full bottle- or breast-feeding is achieved | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months | |
Secondary | Weight growth | Weight growth evaluated through ? z-score analysis | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months | |
Secondary | Duration of respiratory support assigned at randomization | Time during which the non-invasive respiratory support device assigned at randomization is maintained | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months | |
Secondary | Total duration of respiratory support need | Time during which any kind of respiratory support is needed | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months | |
Secondary | Failure of the respiratory support assigned at randomization | Failure of the respiratory support assigned and need for mechanical ventilation or different kind of respiratory support (n. of days) | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months | |
Secondary | Length of hospital stay | Total duration of hospital stay (n. of days) | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months | |
Secondary | Complications | Occurrence of complications as NEC, bowel perforation, pneumothorax, BPD, retinopathy of the premature. | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months |
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