Clinical trial NCT02510560: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Premature Birth of Newborn
Intestinal Malabsorption
Lead sponsor: Elgan Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-29
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Numbers of Days to Achieve Complete Enteral Feeding
timeFrame: 28 days or discharge from hospital
Secondary outcomes:
measure: Number of Days to Achieve Discharge From Hospital or Readiness to Discharge
timeFrame: 28 days or discharge from hospital
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Vidant Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Brussel
country: Belgium
facility: UZ Brussel
city: Liege
country: Belgium
facility: CHR de la Citadelle
city: Rocourt
country: Belgium
facility: CHC Cliniques Saint-Vincent
city: Wilrijk
country: Belgium
facility: GZA Sint-Augustinus
city: Nancy
country: France
facility: CHRU Nancy, Maternité Régionale
city: Paris
country: France
facility: CHU Necker-Enfants Malades
city: Rennes
country: France
facility: CHU - Hôpital Sud
city: Berlin
country: Germany
facility: Kinderklinik, Evangelisches Waldkrankenhaus Spandau
city: Dresden
country: Germany
facility: Klinik und Poliklinik fur Kinder-und Jugendmedizin, Universitaetsklinikum Carl Gustav Carus Dresden
city: Nürnberg
country: Germany
facility: Klinik fur Neugeborene, Kinder und Jugendliche, Universitatsklinik der Paracelsus Medizinischen Privatuniversitat
city: Pforzheim
country: Germany
facility: Klinik fuer Kinder und Jugendliche, Helios Klinikum Pforzheim
city: Spandau
country: Germany
facility: Kinderklinik, Evangelisches Waldkrankenhaus
city: Debrecen
country: Hungary
facility: DE KK Gyermekklinika
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent Gyorgyi Albert Klinikai Kozpont Gyermekgyogyaszati klinika Koraszulott Intenzív Osztaly
city: Székesfehérvár
country: Hungary
facility: Fejéktató Kórhz Újszülött, Csecsemő és Gyermekosztály - Megyei Szent György Egyetemi
city: Veszprém
country: Hungary
facility: Csolnoky Ferenc Korhaz
city: Ashqelon
country: Israel
facility: Barzilai MC
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Bnai Zion MC
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Netanya
country: Israel
facility: Laniado
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center
city: Ramat Gan
country: Israel
facility: Sheba MC
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky MC
city: Ancona
country: Italy
facility: Presidio Ospedaliero G. Salesi - AOUI Ospedali Riuniti di Ancona
city: Milan
country: Italy
facility: Granda Ospedale Maggiore Policlinico
city: Milan
country: Italy
facility: Ospedale dei Bambini "V.Buzzi"- Azienda ICP
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
city: Rome
country: Italy
facility: Policlinico Gemelli
city: Udine
country: Italy
facility: Azienda Ospedaliero Universitaria
city: Varese
country: Italy
facility: Ospedale F. Del Ponte - Azienda Ospedaliera di Varese
city: Amsterdam
country: Netherlands
facility: AMC - Academic Medical Center
city: Groningen
country: Netherlands
facility: UMC Groningen (UMCG), Beatrix Kinderziekenhuis
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Barcelona
country: Spain
facility: Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: La-Paz
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Santiago
country: Spain
facility: CHUS - Complejo Hospitalario Universitario de Santiago
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Leicester
country: United Kingdom
facility: University Hospital of Leicester NHS Trust- Royal Infirmary
city: Nottingham
country: United Kingdom
facility: Queen's Medical College
city: Nottingham
country: United Kingdom
facility: Queens Medical Center
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
Study officials:
References:
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.