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Clinical trials for Necrotizing Enterocolitis

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    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    42 result(s) found for: Necrotizing Enterocolitis. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2019-002548-26 Sponsor Protocol Number: 0139 Start Date*: 2020-12-16
    Sponsor Name:Royal College of Surgeons in Irlenad
    Full Title: Can Pentoxifylline improve long-term outcomes in preterm infants with late-onset sepsis or necrotizing enterocolitis? A pragmatic, randomised, placebo controlled trial
    Medical condition: Late onset sepsis & necrotising enterocolitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10053598 Late onset neonatal sepsis LLT
    20.1 100000004856 10028884 Necrotising enterocolitis LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-000754-22 Sponsor Protocol Number: IBP-9414-020 Start Date*: 2019-10-14
    Sponsor Name:Infant Bacterial Therapeutics AB (IBT)
    Full Title: A randomized, double blind, parallel-group, placebo controlled study to evaluate the efficacy and safety of IBP-9414 in premature infants 500-1500g birth weight in the prevention of necrotizing ent...
    Medical condition: Necrotizing Enterocolitis (NEC)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10052818 Necrotizing enterocolitis neonatal LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) HU (Completed) ES (Ongoing) BG (Completed) PL (Completed) RO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-000453-41 Sponsor Protocol Number: BMBF-Fz01KG1602 Start Date*: 2018-05-29
    Sponsor Name:University Hospital Tuebingen
    Full Title: Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants – a randomized controlled parallel group multicenter trial for safety...
    Medical condition: Extremely low gestational age neonates (ELGANs), i.e. those who are born at <28 weeks gestation and who uniformly suffer from intermittent hypoxemic episodes.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    20.1 10015919 - Eye disorders 10038933 Retinopathy of prematurity PT
    20.1 10017947 - Gastrointestinal disorders 10055667 Necrotising enterocolitis neonatal PT
    20.1 10018065 - General disorders and administration site conditions 10011912 Death neonatal PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10071101 Primary apnoea of premature newborns LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-003177-14 Sponsor Protocol Number: IBUPAR-Trial Start Date*: 2016-04-06
    Sponsor Name:
    Full Title: Paracetamol versus ibuprofen in preterm infants with a hemodynamically significant patent ductus arteriosus: a randomized clinical trial.
    Medical condition: Persistent ductus arteriosus haemodynamically significant
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-004228-70 Sponsor Protocol Number: IBP-9414-010 Start Date*: 2015-12-28
    Sponsor Name:Infant Bacterial Therapeutics AB
    Full Title: A randomized, double blind, parallel-group, dose escalation placebo-controlled multicentre study to investigate the safety and tolerability of IBP-9414 administered in preterm infants
    Medical condition: Prevention of necrotizing enterocolitis in preterm infants with birth weight less than or equal to 1,500 grams
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-003202-77 Sponsor Protocol Number: NEOKOFF22 Start Date*: 2023-04-04
    Sponsor Name:
    Full Title: The effect of additional pre-extubational loading dose of caffeine-citrate
    Medical condition: Extubation failure and bronchopulmonary dysplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10002973 Apnea neonatal LLT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10071132 Primary apnea of premature newborns LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077322 Infantile apnea LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077325 Infantile obstructive apnea LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077328 Infantile central apnea LLT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028975 Neonatal respiratory failure PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    20.0 100000004868 10076729 Very preterm infant LLT
    23.1 100000004868 10084217 Extremely preterm (less than 28 weeks) LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: HU (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2004-002170-34 Sponsor Protocol Number: 2004-002170-34 Start Date*: 2006-03-29
    Sponsor Name:Cambridge University Hospital (Addenbrookes Hospital)
    Full Title: "Ensayo clínico controlado randomizado sobre el tratamiento precoz con insulina en recién nacidos de muy bajo peso"
    Medical condition: Very low birth weight infants requiring intensive care have relative insulin deficiency often leading to hyperglycaemia during the first week of life. There is increasing evidence that the early po...
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-004890-29 Sponsor Protocol Number: FIT-PIV Start Date*: 2023-03-09
    Sponsor Name:Elgan Pharma Ltd
    Full Title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
    Medical condition: Gastro-intestinal malabsorption due to gastro-intestinal immaturity in preterm infants.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10025479 Malabsorption syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) SE (Trial now transitioned) NL (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-005987-15 Sponsor Protocol Number: The Triple P study Start Date*: 2009-10-22
    Sponsor Name:AMC Amsterdam
    Full Title: Preventing preterm birth: Costs and effects of screening of healthy women with a singleton pregnancy for a short cervical length.
    Medical condition: Preterm birth with healthy singleton pregnancies
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036600 Premature labour LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-005717-36 Sponsor Protocol Number: 1645-CI-057 Start Date*: 2012-06-14
    Sponsor Name:Instituto de Investigación Sanitaria La Fe
    Full Title: Extremely low gestational age neonates randomly an assigned to be blindly resuscitated with 21% vs. 60% oxygen: influence upon mortality and chronic conditions in the neonatal period.
    Medical condition: Preterm infants aged 30 weeks or less, who need resuscitation / stabilization maneuvers with positive pressure ventilation immediately after birth
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-000735-80 Sponsor Protocol Number: 2010-382 Start Date*: 2011-05-16
    Sponsor Name:Lene Drasbek Huusom
    Full Title: Administration of antenatal magnesium sulphate for prevention of cerebral palsy in preterm infants (MASP-STUDY)
    Medical condition: Moderate to severe cerebral palsy
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005791-35 Sponsor Protocol Number: SHP633-302 Start Date*: 2020-12-23
    Sponsor Name:Shire
    Full Title: A 24-week Safety, Efficacy, Pharmacodynamic, and Pharmacokinetic Study of Teduglutide in Japanese Pediatric Subjects, Aged 4 Months Through 15 Years, With Short Bowel Syndrome Who Are Dependent on ...
    Medical condition: Treatment of short bowel syndrome dependent on parenteral support
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-003220-31 Sponsor Protocol Number: 54463 Start Date*: 2016-06-21
    Sponsor Name:VU medical center, Amsterdam
    Full Title: Low dose aspirin in the Prevention of Recurrent Spontaneous Preterm Labour – the APRIL study
    Medical condition: Prevention of recurrent spontaneous preterm birth
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-007498-19 Sponsor Protocol Number: COL-1620-302 Start Date*: 2009-09-17
    Sponsor Name:Columbia Laboratories, Inc
    Full Title: The Effect of Vaginal Progesterone Administration in the prevention of Preterm Birth in Women with Short Cervix, [also Known as: Vaginal progesterone bioadhesive gel (Prochieve)® Extending Gestatio...
    Medical condition: Preterm birth (less than or equal to 32 6/7 weeks gestation)
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-000896-30 Sponsor Protocol Number: Uni-Koeln-439 Start Date*: 2009-02-09
    Sponsor Name:University of Cologne
    Full Title: Surfactant application during spontaneous breathing with CPAP or during mechanical ventilation in the therapy of IRDS in premature infants <27 weeks
    Medical condition: Idiopathic Respiratory Distress Syndrome (IRDS) in preterm infants
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10021735 Infant respiratory distress syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-004526-33 Sponsor Protocol Number: PDARCT1 Start Date*: Information not available in EudraCT
    Sponsor Name:Royal College of Surgeons in Ireland
    Full Title: A Randomised Controlled Trial of Early Targeted Patent Ductus Arteriosus Treatment Using a Risk Based Severity Score
    Medical condition: Patent Ductus Arteriosus
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10034130 Patent ductus arteriosus PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2017-001007-72 Sponsor Protocol Number: 80-84800-98-41027 Start Date*: 2017-07-06
    Sponsor Name:Amsterdam UMC location AMC
    Full Title: Atosiban versus placebo in the treatment of late threatened preterm birth (APOSTEL VIII).
    Medical condition: Neonatal outcome in threatened preterm birth between 30 and 34 weeks of gestation.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-004482-14 Sponsor Protocol Number: P160917 Start Date*: 2019-08-14
    Sponsor Name:ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS (AP-HP)
    Full Title: Tocolysis in the management of preterm premature rupture of membranes before 34 weeks of gestation: a double-blinded randomized controlled trial
    Medical condition: Pregnant women with PPROM at 22 to 33 weeks gestation
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-020464-38 Sponsor Protocol Number: PRENU Start Date*: 2010-06-08
    Sponsor Name:University of Oslo
    Full Title: Nutrition, growth and development among very preterm infants
    Medical condition: The main purpose of this study is to evaluate the effect of increased supply of energy, protein, vitamin A and the long chain polyunsaturated fatty acids DHA and AA to Very Low Birth Weight Infants...
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: NO (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-004297-26 Sponsor Protocol Number: C19-29 Start Date*: 2020-04-17
    Sponsor Name:Institut National de la Santé et de la Recherche Médicale (INSERM)
    Full Title: Prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen
    Medical condition: Patent ductus arteriosus
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) EE (Completed) IE (Completed) FI (Completed) BE (Completed) PT (Completed) SE (Completed) HU (Completed) DK (Completed) GB (Not Authorised) NO (Completed) AT (Completed) GR (Completed) PL (Ongoing) IT (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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