Premature Birth of Newborn Clinical Trial
Official title:
A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
| Verified date | May 2018 |
| Source | Nutrinia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.
| Status | Active, not recruiting |
| Enrollment | 530 |
| Est. completion date | August 2021 |
| Est. primary completion date | May 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 5 Days |
| Eligibility |
Inclusion Criteria 1. Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound 2. Birth weight = 500g 3. Singleton or twin birth Exclusion Criteria 1. Complete enteral feeding |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | AZ Sint-Jan | Brugge | |
| Belgium | UZ Brussel | Brussel | |
| Belgium | CHR de la Citadelle | Liege | |
| Belgium | CHC Cliniques Saint-Vincent | Rocourt | |
| Belgium | GZA Sint-Augustinus | Wilrijk | |
| France | CHRU Nancy, Maternité Régionale | Nancy | |
| France | CHU Necker-Enfants Malades | Paris | |
| France | CHU - Hôpital Sud | Rennes | |
| Germany | Kinderklinik, Evangelisches Waldkrankenhaus Spandau | Berlin | |
| Germany | Klinik und Poliklinik fur Kinder-und Jugendmedizin, Universitaetsklinikum Carl Gustav Carus Dresden | Dresden | |
| Germany | Klinik fur Neugeborene, Kinder und Jugendliche, Universitatsklinik der Paracelsus Medizinischen Privatuniversitat | Nürnberg | |
| Germany | Klinik fuer Kinder und Jugendliche, Helios Klinikum Pforzheim | Pforzheim | |
| Germany | Kinderklinik, Evangelisches Waldkrankenhaus | Spandau | |
| Hungary | DE KK Gyermekklinika | Debrecen | |
| Hungary | Szegedi Tudomanyegyetem Szent Gyorgyi Albert Klinikai Kozpont Gyermekgyogyaszati klinika Koraszulott Intenzív Osztaly | Szeged | |
| Hungary | Fejéktató Kórhz Újszülött, Csecsemo és Gyermekosztály - Megyei Szent György Egyetemi | Székesfehérvár | |
| Hungary | Csolnoky Ferenc Korhaz | Veszprém | |
| Israel | Barzilai MC | Ashqelon | |
| Israel | Soroka Medical Center | Be'er Sheva | |
| Israel | Bnai Zion MC | Haifa | |
| Israel | Rambam Health Care Campus | Haifa | |
| Israel | Laniado | Netanya | |
| Israel | Schneider Children's Medical Center | Petach Tikva | |
| Israel | Sheba MC | Ramat Gan | |
| Israel | Tel Aviv Sourasky MC | Tel Aviv | |
| Italy | Presidio Ospedaliero G. Salesi - AOUI Ospedali Riuniti di Ancona | Ancona | |
| Italy | Granda Ospedale Maggiore Policlinico | Milan | |
| Italy | Ospedale dei Bambini "V.Buzzi"- Azienda ICP | Milan | |
| Italy | Azienda Ospedaliera San Gerardo | Monza | |
| Italy | Policlinico Gemelli | Rome | |
| Italy | Azienda Ospedaliero Universitaria | Udine | |
| Italy | Ospedale F. Del Ponte - Azienda Ospedaliera di Varese | Varese | |
| Netherlands | AMC - Academic Medical Center | Amsterdam | |
| Netherlands | UMC Groningen (UMCG), Beatrix Kinderziekenhuis | Groningen | |
| Netherlands | Isala Klinieken | Zwolle | |
| Spain | Vall d'Hebron | Barcelona | |
| Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
| Spain | La-Paz | Madrid | |
| Spain | Hospital Universitario Virgen de la Arrixaca | Murcia | |
| Spain | CHUS - Complejo Hospitalario Universitario de Santiago | Santiago | |
| Spain | Hospital Universitario La Fe | Valencia | |
| United Kingdom | Bradford Royal Infirmary | Bradford | |
| United Kingdom | University Hospital of Leicester NHS Trust- Royal Infirmary | Leicester | |
| United Kingdom | Queen's Medical College | Nottingham | |
| United Kingdom | Queens Medical Center | Nottingham | |
| United Kingdom | Portsmouth Hospitals NHS Trust | Portsmouth | |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Vidant Medical Center | Greenville | North Carolina |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| Nutrinia |
United States, Belgium, France, Germany, Hungary, Israel, Italy, Netherlands, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Numbers of days to achieve complete enteral feeding | 28 days or discharge from hosital | ||
| Secondary | Number of days to achieve discharge from hospital or readiness to discharge | 28 days or discharge from hospital | ||
| Secondary | Growth velocity (g/kg/day) | 28 days or discharge from hospital |
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