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

Primary Purpose

Premature Birth of Newborn, Intestinal Malabsorption

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NTRA-2112
Placebo
Sponsored by
Nutrinia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Birth of Newborn

Eligibility Criteria

1 Day - 5 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vidant Medical Center
  • University of Oklahoma Health Sciences Center
  • Medical University of South Carolina
  • Vanderbilt University Medical Center
  • AZ Sint-Jan
  • UZ Brussel
  • CHR de la Citadelle
  • CHC Cliniques Saint-Vincent
  • GZA Sint-Augustinus
  • CHRU Nancy, Maternité Régionale
  • CHU Necker-Enfants Malades
  • CHU - Hôpital Sud
  • Kinderklinik, Evangelisches Waldkrankenhaus Spandau
  • Klinik und Poliklinik fur Kinder-und Jugendmedizin, Universitaetsklinikum Carl Gustav Carus Dresden
  • Klinik fur Neugeborene, Kinder und Jugendliche, Universitatsklinik der Paracelsus Medizinischen Privatuniversitat
  • Klinik fuer Kinder und Jugendliche, Helios Klinikum Pforzheim
  • Kinderklinik, Evangelisches Waldkrankenhaus
  • DE KK Gyermekklinika
  • Szegedi Tudomanyegyetem Szent Gyorgyi Albert Klinikai Kozpont Gyermekgyogyaszati klinika Koraszulott Intenzív Osztaly
  • Fejéktató Kórhz Újszülött, Csecsemő és Gyermekosztály - Megyei Szent György Egyetemi
  • Csolnoky Ferenc Korhaz
  • Barzilai MC
  • Soroka Medical Center
  • Bnai Zion MC
  • Rambam Health Care Campus
  • Laniado
  • Schneider Children's Medical Center
  • Sheba MC
  • Tel Aviv Sourasky MC
  • Presidio Ospedaliero G. Salesi - AOUI Ospedali Riuniti di Ancona
  • Granda Ospedale Maggiore Policlinico
  • Ospedale dei Bambini "V.Buzzi"- Azienda ICP
  • Azienda Ospedaliera San Gerardo
  • Policlinico Gemelli
  • Azienda Ospedaliero Universitaria
  • Ospedale F. Del Ponte - Azienda Ospedaliera di Varese
  • AMC - Academic Medical Center
  • UMC Groningen (UMCG), Beatrix Kinderziekenhuis
  • Isala Klinieken
  • Vall d'Hebron
  • Hospital General Universitario Gregorio Marañon
  • La-Paz
  • Hospital Universitario Virgen de la Arrixaca
  • CHUS - Complejo Hospitalario Universitario de Santiago
  • Hospital Universitario La Fe
  • Bradford Royal Infirmary
  • University Hospital of Leicester NHS Trust- Royal Infirmary
  • Queen's Medical College
  • Queens Medical Center
  • Portsmouth Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

NTRA-2112 A

NTRA-2112 B

Placebo

Arm Description

NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.

NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.

Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.

Outcomes

Primary Outcome Measures

Numbers of days to achieve complete enteral feeding

Secondary Outcome Measures

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

Full Information

First Posted
July 24, 2015
Last Updated
May 28, 2018
Sponsor
Nutrinia
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1. Study Identification

Unique Protocol Identification Number
NCT02510560
Brief Title
Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutrinia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth of Newborn, Intestinal Malabsorption

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
530 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NTRA-2112 A
Arm Type
Experimental
Arm Description
NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.
Arm Title
NTRA-2112 B
Arm Type
Experimental
Arm Description
NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.
Intervention Type
Drug
Intervention Name(s)
NTRA-2112
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Numbers of days to achieve complete enteral feeding
Time Frame
28 days or discharge from hosital
Secondary Outcome Measure Information:
Title
Number of days to achieve discharge from hospital or readiness to discharge
Time Frame
28 days or discharge from hospital
Title
Growth velocity (g/kg/day)
Time Frame
28 days or discharge from hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
5 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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 Exclusion Criteria 1. Complete enteral feeding
Facility Information:
Facility Name
Vidant Medical Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
AZ Sint-Jan
City
Brugge
Country
Belgium
Facility Name
UZ Brussel
City
Brussel
Country
Belgium
Facility Name
CHR de la Citadelle
City
Liege
Country
Belgium
Facility Name
CHC Cliniques Saint-Vincent
City
Rocourt
Country
Belgium
Facility Name
GZA Sint-Augustinus
City
Wilrijk
Country
Belgium
Facility Name
CHRU Nancy, Maternité Régionale
City
Nancy
Country
France
Facility Name
CHU Necker-Enfants Malades
City
Paris
Country
France
Facility Name
CHU - Hôpital Sud
City
Rennes
Country
France
Facility Name
Kinderklinik, Evangelisches Waldkrankenhaus Spandau
City
Berlin
Country
Germany
Facility Name
Klinik und Poliklinik fur Kinder-und Jugendmedizin, Universitaetsklinikum Carl Gustav Carus Dresden
City
Dresden
Country
Germany
Facility Name
Klinik fur Neugeborene, Kinder und Jugendliche, Universitatsklinik der Paracelsus Medizinischen Privatuniversitat
City
Nürnberg
Country
Germany
Facility Name
Klinik fuer Kinder und Jugendliche, Helios Klinikum Pforzheim
City
Pforzheim
Country
Germany
Facility Name
Kinderklinik, Evangelisches Waldkrankenhaus
City
Spandau
Country
Germany
Facility Name
DE KK Gyermekklinika
City
Debrecen
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent Gyorgyi Albert Klinikai Kozpont Gyermekgyogyaszati klinika Koraszulott Intenzív Osztaly
City
Szeged
Country
Hungary
Facility Name
Fejéktató Kórhz Újszülött, Csecsemő és Gyermekosztály - Megyei Szent György Egyetemi
City
Székesfehérvár
Country
Hungary
Facility Name
Csolnoky Ferenc Korhaz
City
Veszprém
Country
Hungary
Facility Name
Barzilai MC
City
Ashqelon
Country
Israel
Facility Name
Soroka Medical Center
City
Be'er Sheva
Country
Israel
Facility Name
Bnai Zion MC
City
Haifa
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel
Facility Name
Laniado
City
Netanya
Country
Israel
Facility Name
Schneider Children's Medical Center
City
Petach Tikva
Country
Israel
Facility Name
Sheba MC
City
Ramat Gan
Country
Israel
Facility Name
Tel Aviv Sourasky MC
City
Tel Aviv
Country
Israel
Facility Name
Presidio Ospedaliero G. Salesi - AOUI Ospedali Riuniti di Ancona
City
Ancona
Country
Italy
Facility Name
Granda Ospedale Maggiore Policlinico
City
Milan
Country
Italy
Facility Name
Ospedale dei Bambini "V.Buzzi"- Azienda ICP
City
Milan
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo
City
Monza
Country
Italy
Facility Name
Policlinico Gemelli
City
Rome
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria
City
Udine
Country
Italy
Facility Name
Ospedale F. Del Ponte - Azienda Ospedaliera di Varese
City
Varese
Country
Italy
Facility Name
AMC - Academic Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
UMC Groningen (UMCG), Beatrix Kinderziekenhuis
City
Groningen
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands
Facility Name
Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
Country
Spain
Facility Name
La-Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
CHUS - Complejo Hospitalario Universitario de Santiago
City
Santiago
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
Country
Spain
Facility Name
Bradford Royal Infirmary
City
Bradford
Country
United Kingdom
Facility Name
University Hospital of Leicester NHS Trust- Royal Infirmary
City
Leicester
Country
United Kingdom
Facility Name
Queen's Medical College
City
Nottingham
Country
United Kingdom
Facility Name
Queens Medical Center
City
Nottingham
Country
United Kingdom
Facility Name
Portsmouth Hospitals NHS Trust
City
Portsmouth
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35226099
Citation
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.
Results Reference
derived

Learn more about this trial

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

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