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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Premature Birth of Newborn, Intestinal Malabsorption

In brief

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

Key facts

Study ID

NCT02510560

Run by

Elgan Pharma Ltd.

People needed

300

Starts

2016-10-09

Expected to finish

2018-04-25

Last updated by the study team

2025-08-19

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Birth weight ≥ 500g
• Singleton or twin birth

You may not qualify if…

• Complete enteral feeding

Where it is running

• Vidant Medical Center — Greenville, North Carolina, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• AZ Sint-Jan — Bruges, Belgium
• UZ Brussel — Brussels, Belgium
• CHR de la Citadelle — Liège, Belgium
• CHC Cliniques Saint-Vincent — Rocourt, Belgium
• GZA Sint-Augustinus — Wilrijk, Belgium
• CHRU Nancy, Maternité Régionale — Nancy, France
• CHU Necker-Enfants Malades — Paris, France
• CHU - Hôpital Sud — Rennes, France
• 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 — Nuremberg, Germany
• Klinik fuer Kinder und Jugendliche, Helios Klinikum Pforzheim — Pforzheim, Germany
• Kinderklinik, Evangelisches Waldkrankenhaus — Spandau, Germany
• DE KK Gyermekklinika — Debrecen, Hungary
• 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
• Csolnoky Ferenc Korhaz — Veszprém, Hungary
• Barzilai MC — Ashkelon, Israel
• Soroka Medical Center — Beersheba, Israel
• Bnai Zion MC — Haifa, Israel
• Rambam Health Care Campus — Haifa, Israel

Full record on ClinicalTrials.gov

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