Study Stopped
Sponsor decision
Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
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
1 other identifier
interventional
300
10 countries
50
Brief Summary
The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2016
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2015
CompletedFirst Posted
Study publicly available on registry
July 29, 2015
CompletedStudy Start
First participant enrolled
October 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2018
CompletedResults Posted
Study results publicly available
June 6, 2025
CompletedAugust 19, 2025
July 1, 2025
1.5 years
July 24, 2015
May 22, 2025
July 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Numbers of Days to Achieve Complete Enteral Feeding
Numbers of days to achieve full enteral feeding (NFE) is defined as: Number of Days to the first day of achieving enteral feeding of at least 150 ml/kg/day, which must be sustained for at least 3 consecutive days.
28 days or discharge from hospital
Secondary Outcomes (1)
Number of Days to Achieve Discharge From Hospital or Readiness to Discharge
28 days or discharge from hospital
Study Arms (3)
NTRA-2112 A
EXPERIMENTALNTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.
NTRA-2112 B
EXPERIMENTALNTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.
Placebo
PLACEBO COMPARATORPlacebo To be administered orally with daily feed for 28 days or until discharge from hospital.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Vidant Medical Center
Greenville, North Carolina, 27834, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, 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
Laniado
Netanya, Israel
Schneider Children's Medical Center
Petah Tikva, Israel
Sheba MC
Ramat Gan, Israel
Tel Aviv Sourasky MC
Tel Aviv, Israel
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
AMC - Academic Medical Center
Amsterdam, Netherlands
UMC Groningen (UMCG), Beatrix Kinderziekenhuis
Groningen, Netherlands
Isala Klinieken
Zwolle, Netherlands
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, Spain
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 Kingdom
Related Publications (1)
Mank E, Saenz de Pipaon M, Lapillonne A, Carnielli VP, Senterre T, Shamir R, van Toledo L, van Goudoever JB; FIT-04 Study Group. Efficacy and Safety of Enteral Recombinant Human Insulin in Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2022 May 1;176(5):452-460. doi: 10.1001/jamapediatrics.2022.0020.
PMID: 35226099DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Miki Olshansky, Chief Executive Officer
- Organization
- Elgan Pharma Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2015
First Posted
July 29, 2015
Study Start
October 9, 2016
Primary Completion
April 25, 2018
Study Completion
April 25, 2018
Last Updated
August 19, 2025
Results First Posted
June 6, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share