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

May 28, 2018 updated by: Nutrinia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

530

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium
        • AZ Sint-Jan
      • Brussel, Belgium
        • UZ Brussel
      • Liege, Belgium
        • Chr de La Citadelle
      • Rocourt, Belgium
        • CHC Cliniques Saint-Vincent
      • Wilrijk, Belgium
        • GZA Sint-Augustinus
  • France
      • Nancy, France
        • CHRU Nancy, Maternité Régionale
      • Paris, France
        • CHU Necker-Enfants Malades
      • Rennes, France
        • CHU - Hôpital Sud
  • Germany
      • Berlin, Germany
        • Kinderklinik, Evangelisches Waldkrankenhaus Spandau
      • Dresden, Germany
        • Klinik und Poliklinik fur Kinder-und Jugendmedizin, Universitaetsklinikum Carl Gustav Carus Dresden
      • Nürnberg, Germany
        • Klinik fur Neugeborene, Kinder und Jugendliche, Universitatsklinik der Paracelsus Medizinischen Privatuniversitat
      • Pforzheim, Germany
        • Klinik fuer Kinder und Jugendliche, Helios Klinikum Pforzheim
      • Spandau, Germany
        • Kinderklinik, Evangelisches Waldkrankenhaus
  • Hungary
      • Debrecen, Hungary
        • DE KK Gyermekklinika
      • Szeged, Hungary
        • Szegedi Tudomanyegyetem Szent Gyorgyi Albert Klinikai Kozpont Gyermekgyogyaszati klinika Koraszulott Intenzív Osztaly
      • Székesfehérvár, Hungary
        • Fejéktató Kórhz Újszülött, Csecsemő és Gyermekosztály - Megyei Szent György Egyetemi
      • Veszprém, Hungary
        • Csolnoky Ferenc Korhaz
  • Israel
      • Ashqelon, Israel
        • Barzilai MC
      • Be'er Sheva, Israel
        • Soroka Medical Center
      • Haifa, Israel
        • Rambam Health Care Campus
      • Haifa, Israel
        • Bnai Zion Mc
      • Netanya, Israel
        • Laniado
      • Petach Tikva, Israel
        • Schneider Children's Medical Center
      • Ramat Gan, Israel
        • Sheba MC
      • Tel Aviv, Israel
        • Tel Aviv Sourasky MC
  • Italy
      • Ancona, Italy
        • Presidio Ospedaliero G. Salesi - AOUI Ospedali Riuniti di Ancona
      • Milan, Italy
        • Granda Ospedale Maggiore Policlinico
      • Milan, Italy
        • Ospedale dei Bambini "V.Buzzi"- Azienda ICP
      • Monza, Italy
        • Azienda Ospedaliera San Gerardo
      • Rome, Italy
        • Policlinico Gemelli
      • Udine, Italy
        • Azienda Ospedaliero Universitaria
      • Varese, Italy
        • Ospedale F. Del Ponte - Azienda Ospedaliera di Varese
  • Netherlands
      • Amsterdam, Netherlands
        • AMC - Academic Medical Center
      • Groningen, Netherlands
        • UMC Groningen (UMCG), Beatrix Kinderziekenhuis
      • Zwolle, Netherlands
        • Isala Klinieken
  • Spain
      • Barcelona, Spain
        • Vall d'Hebron
      • Madrid, Spain
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain
        • La-Paz
      • Murcia, Spain
        • Hospital Universitario Virgen de la Arrixaca
      • Santiago, Spain
        • CHUS - Complejo Hospitalario Universitario de Santiago
      • Valencia, Spain
        • Hospital Universitario La Fe
  • United Kingdom
      • Bradford, United Kingdom
        • Bradford Royal Infirmary
      • Leicester, United Kingdom
        • University Hospital of Leicester NHS Trust- Royal Infirmary
      • Nottingham, United Kingdom
        • Queen's Medical College
      • Nottingham, United Kingdom
        • Queens Medical Center
      • Portsmouth, United Kingdom
        • Portsmouth Hospitals NHS Trust
  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Vidant Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 5 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NTRA-2112 A
NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.
Drug: NTRA-2112
Experimental: NTRA-2112 B
NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.
Drug: NTRA-2112
Placebo Comparator: Placebo
Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numbers of days to achieve complete enteral feeding
Time Frame: 28 days or discharge from hosital
28 days or discharge from hosital

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of days to achieve discharge from hospital or readiness to discharge
Time Frame: 28 days or discharge from hospital
28 days or discharge from hospital
Growth velocity (g/kg/day)
Time Frame: 28 days or discharge from hospital
28 days or discharge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutrinia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

July 24, 2015

First Submitted That Met QC Criteria

July 26, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Actual)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 28, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIT-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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