Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants

Phase 3

• Conditions: Premature Birth of Newborn; Intestinal Malabsorption
• Interventions: Drug: NTRA-2112; Drug: Placebo

• Registration Number: NCT02510560
• Lead Sponsor: Nutrinia

Brief Summary

The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.

Detailed Description

The study will assess the efficacy and safety of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo

Study Timeline

• Study First Submitted: 2015-07-24
• Study First Submitted QC: 2015-07-26
• Study First Posted: 2015-07-29
• Study Start: 2016-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-28
• Last Update Posted: 2018-05-30
• Primary Completion: 2019-05
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NTRA-2112 A	NTRA-2112	NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.
Placebo	Placebo	Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.
NTRA-2112 B	NTRA-2112	NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.

Primary Outcome Measures

Name	Time	Method
Numbers of days to achieve complete enteral feeding	28 days or discharge from hosital

Secondary Outcome Measures

Name	Time	Method
Growth velocity (g/kg/day)	28 days or discharge from hospital
Number of days to achieve discharge from hospital or readiness to discharge	28 days or discharge from hospital

Trial Locations

Locations (50)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Vidant Medical Center; 🇺🇸 Greenville, North Carolina, United States

CHU Necker-Enfants Malades; 🇫🇷 Paris, France

CHU - Hôpital Sud; 🇫🇷 Rennes, France

CHRU Nancy, Maternité Régionale; 🇫🇷 Nancy, France

Kinderklinik, Evangelisches Waldkrankenhaus Spandau; 🇩🇪 Berlin, Germany

Klinik und Poliklinik fur Kinder-und Jugendmedizin, Universitaetsklinikum Carl Gustav Carus Dresden; 🇩🇪 Dresden, Germany

Kinderklinik, Evangelisches Waldkrankenhaus; 🇩🇪 Spandau, Germany

Klinik fuer Kinder und Jugendliche, Helios Klinikum Pforzheim; 🇩🇪 Pforzheim, Germany

Klinik fur Neugeborene, Kinder und Jugendliche, Universitatsklinik der Paracelsus Medizinischen Privatuniversitat; 🇩🇪 Nürnberg, Germany

Barzilai MC; 🇮🇱 Ashqelon, Israel

Sheba MC; 🇮🇱 Ramat Gan, Israel

Laniado; 🇮🇱 Netanya, Israel

Schneider Children's Medical Center; 🇮🇱 Petach Tikva, Israel

Tel Aviv Sourasky MC; 🇮🇱 Tel Aviv, Israel

AMC - Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Vall d'Hebron; 🇪🇸 Barcelona, Spain

La-Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital General Universitario Gregorio Marañon; 🇪🇸 Madrid, Spain

CHUS - Complejo Hospitalario Universitario de Santiago; 🇪🇸 Santiago, Spain

University Hospital of Leicester NHS Trust- Royal Infirmary; 🇬🇧 Leicester, United Kingdom

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain

Portsmouth Hospitals NHS Trust; 🇬🇧 Portsmouth, United Kingdom

Bradford Royal Infirmary; 🇬🇧 Bradford, United Kingdom

Queen's Medical College; 🇬🇧 Nottingham, United Kingdom

Queens Medical Center; 🇬🇧 Nottingham, United Kingdom

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

AZ Sint-Jan; 🇧🇪 Brugge, Belgium

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, Italy

CHR de la Citadelle; 🇧🇪 Liege, Belgium

DE KK Gyermekklinika; 🇭🇺 Debrecen, Hungary

Bnai Zion MC; 🇮🇱 Haifa, Israel

Rambam Health Care Campus; 🇮🇱 Haifa, Israel

CHC Cliniques Saint-Vincent; 🇧🇪 Rocourt, Belgium

GZA Sint-Augustinus; 🇧🇪 Wilrijk, Belgium

Csolnoky Ferenc Korhaz; 🇭🇺 Veszprém, Hungary

Soroka Medical Center; 🇮🇱 Be'er Sheva, Israel

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

UZ Brussel; 🇧🇪 Brussel, Belgium

Isala Klinieken; 🇳🇱 Zwolle, Netherlands

Szegedi Tudomanyegyetem Szent Gyorgyi Albert Klinikai Kozpont Gyermekgyogyaszati klinika Koraszulott Intenzív Osztaly; 🇭🇺 Szeged, Hungary

Fejéktató Kórhz Újszülött, Csecsemő és Gyermekosztály - Megyei Szent György Egyetemi; 🇭🇺 Székesfehérvár, Hungary

UMC Groningen (UMCG), Beatrix Kinderziekenhuis; 🇳🇱 Groningen, Netherlands