Premature Birth of NewbornPhase 3NCT02510560
Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
A Phase 3 study testing NTRA-2112 in people with Premature Birth of Newborn and Intestinal Malabsorption, run by Elgan Pharma Ltd. at 50 sites in 10 countries.
Trial summary
The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants. Read more about this study
- Who is it for?
- Ages 1 day to 5 days
- Conditions the study is for
- Premature Birth of Newborn, Intestinal Malabsorption
- What is being tested?
- NTRA-2112
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 50 sitesin 10 countries
- Study dates
- 9 Oct 2016to 25 Apr 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 5 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 1. Complete enteral feeding
Trial locations and contacts
50 sites in 10 countries.
50 sites in 10 countries
Israel8 sites
Barzilai MC
Ashkelon
Soroka Medical Center
Beersheba
Bnai Zion MC
Haifa
Rambam Health Care Campus
Haifa
Laniado
Netanya
Schneider Children's Medical Center
Petah Tikva
Sheba MC
Ramat Gan
Tel Aviv Sourasky MC
Tel Aviv
Italy7 sites
Presidio Ospedaliero G. Salesi - AOUI Ospedali Riuniti di Ancona
Ancona
Granda Ospedale Maggiore Policlinico
Milan
Ospedale dei Bambini "V.Buzzi"- Azienda ICP
Milan
Azienda Ospedaliera San Gerardo
Monza
Policlinico Gemelli
Rome
Azienda Ospedaliero Universitaria
Udine
Ospedale F. Del Ponte - Azienda Ospedaliera di Varese
Varese
Spain6 sites
Vall d'Hebron
Barcelona
Hospital General Universitario Gregorio Marañon
Madrid
La-Paz
Madrid
Hospital Universitario Virgen de la Arrixaca
Murcia
CHUS - Complejo Hospitalario Universitario de Santiago
Santiago
Hospital Universitario La Fe
Valencia
Belgium5 sites
AZ Sint-Jan
Bruges
UZ Brussel
Brussels
CHR de la Citadelle
Liège
CHC Cliniques Saint-Vincent
Rocourt
GZA Sint-Augustinus
Wilrijk
Germany5 sites
Kinderklinik, Evangelisches Waldkrankenhaus Spandau
Berlin
Klinik und Poliklinik fur Kinder-und Jugendmedizin, Universitaetsklinikum Carl Gustav Carus Dresden
Dresden
Klinik fur Neugeborene, Kinder und Jugendliche, Universitatsklinik der Paracelsus Medizinischen Privatuniversitat
Nuremberg
Klinik fuer Kinder und Jugendliche, Helios Klinikum Pforzheim
Pforzheim
Kinderklinik, Evangelisches Waldkrankenhaus
Spandau
United Kingdom5 sites
Bradford Royal Infirmary
Bradford
University Hospital of Leicester NHS Trust- Royal Infirmary
Leicester
Queen's Medical College
Nottingham
Queens Medical Center
Nottingham
Portsmouth Hospitals NHS Trust
Portsmouth
United States4 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Vidant Medical Center
Greenville, North Carolina, 27834
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Hungary4 sites
DE KK Gyermekklinika
Debrecen
Szegedi Tudomanyegyetem Szent Gyorgyi Albert Klinikai Kozpont Gyermekgyogyaszati klinika Koraszulott Intenzív Osztaly
Szeged
Fejéktató Kórhz Újszülött, Csecsemő és Gyermekosztály - Megyei Szent György Egyetemi
Székesfehérvár
Csolnoky Ferenc Korhaz
Veszprém
France3 sites
CHRU Nancy, Maternité Régionale
Nancy
CHU Necker-Enfants Malades
Paris
CHU - Hôpital Sud
Rennes
Netherlands3 sites
AMC - Academic Medical Center
Amsterdam
UMC Groningen (UMCG), Beatrix Kinderziekenhuis
Groningen
Isala Klinieken
Zwolle
About this study
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
The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.
Read the detailed description
The study will assess the efficacy and safety of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo
- Being tested
- NTRA-2112, Placebo
- Medical subject headings
- Premature Birth, Malabsorption Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTRA-2112Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| NTRA-2112 A | Experimental | NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital. Receives: Drug: NTRA-2112 |
| NTRA-2112 B | Experimental | NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital. Receives: Drug: NTRA-2112 |
| Placebo | Placebo comparator | Placebo To be administered orally with daily feed for 28 days or until discharge from hospital. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days or discharge from hospital
Secondary outcomes (1)
Number of Days to Achieve Discharge From Hospital or Readiness to Discharge
Readiness for discharge from hospital is defined as achieving all of the below:
- Infant weight ≥ 1800g
- Stable body temperature
- Capable of oral feeding (reached full enteral feeding and not dependent on PN)
Measured: 28 days or discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study start9 Oct 2016
- Primary completion25 Apr 2018
- Study completion25 Apr 2018
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature Birth of NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elgan Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510560
- Sponsor's protocol ID
- FIT-04
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2015
- Last updated
- 19 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35226099
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02510560
- Acronym / sponsor ID
- FIT-04
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Elgan Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2016 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NTRA-2112 A | Experimental | Drug: NTRA-2112NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital. |
| NTRA-2112 B | Experimental | Drug: NTRA-2112NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo To be administered orally with daily feed for 28 days or until discharge from hospital. |
Who may qualify
- Ages
- 1 day to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Complete enteral feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTRA-2112 | Drug | NTRA-2112 A, NTRA-2112 B |
| Placebo | Drug | Placebo |
Primary outcome
Numbers of Days to Achieve Complete Enteral Feeding
Time frame: 28 days or discharge from hospital
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.
1 secondary outcome
Number of Days to Achieve Discharge From Hospital or Readiness to Discharge
Time frame: 28 days or discharge from hospital
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35226099Mank 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
50 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NTRA-2112 in people with Premature Birth of Newborn and Intestinal Malabsorption, run by Elgan Pharma Ltd. at 50 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Israel, Italy, Spain, Belgium, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of Days to Achieve Complete Enteral Feeding (time frame: 28 days or discharge from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02510560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.