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Clinical trials for Infants

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44365   clinical trials with a EudraCT protocol, of which   7389   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    941 result(s) found for: Infants. Displaying page 1 of 48.
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    EudraCT Number: 2016-004325-16 Sponsor Protocol Number: RC31/16/8407 Start Date*: 2016-12-22
    Sponsor Name:University Hospital of Toulouse
    Full Title: Long term evaluation of infants aged from 3 to 4 years old included in the OTBB2 study (repeated administrations of oxytocin in infants with PWS aged from 0 to 6 months) and comparison with not tre...
    Medical condition: Prader Willi Syndrom
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-001458-24 Sponsor Protocol Number: VAC-264 Start Date*: 2012-09-03
    Sponsor Name:RIVM
    Full Title: Cross-sectional surveillance study on pneumococcal serotypes and other pathogens in nasopharyngeal samples from infants and parents performed 6.5 years after introduction of pneumococcal vaccinatio...
    Medical condition: The study investigates the presence of nasopharyngeal vaccine- and non-vaccine pneumococcal serotypes in 11- and 24-month-old infants and parents, 6.5 years after implementation of a pneumococcal v...
    Disease:
    Population Age: Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (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: 2011-005456-33 Sponsor Protocol Number: Start Date*: 2012-01-26
    Sponsor Name:Med. Univ. Wien, Universitätsklinik für Kinder- und Jugendheilkunde
    Full Title: PREVENTING CHOLESTASIS IN PREMATURE INFANTS USING SMOFLIPID
    Medical condition: • To compare a mixed parenteral lipid emulsion containing fish oil (SMOFlipid®) with a soybean oil based lipid emulsion (Intralipid®) for its effect on the occurrence of parenteral nutrition associ...
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2007-000851-33 Sponsor Protocol Number: 27112001 Start Date*: 2008-04-28
    Sponsor Name:Medizinische Unversität Wien, Abteilung für Kinder- und Jugendheilkunde
    Full Title: Impact of oral application of Gastrografin on the meconium evacuation in very low birth weight infants
    Medical condition: Evacuation of inspissated meconium in very low birth weight infants (infants with a birthweight below 1500 grams)
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2022-004195-42 Sponsor Protocol Number: FIT-05 Start Date*: 2023-04-13
    Sponsor Name:Elgan Pharma Ltd
    Full Title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Populations of Interest
    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) SE (Ongoing) ES (Ongoing) NL (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-000499-24 Sponsor Protocol Number: 200722 Start Date*: 2015-02-16
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
    Medical condition: preterm labour and improve neonatal health
    Disease: Version SOC Term Classification Code Term Level
    20.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036595 Premature delivery PT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) ES (Completed) SE (Completed) DE (Completed) IT (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2014-005032-34 Sponsor Protocol Number: MK-0991-058 Start Date*: 2015-02-27
    Sponsor Name:Merck & Co., Inc.
    Full Title: A Multicenter, Sequential-Panel, Open-Label, Noncomparative Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Caspofungin Acetate in Neonates and Infants Less Than 3 Months of ...
    Medical condition: Empirical therapy for fungal infections
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-000069-41 Sponsor Protocol Number: THCHOG-2008-01 Start Date*: 2008-04-09
    Sponsor Name:Erasmus MC
    Full Title: Regulation of colloid osmotic pressure during cardiopulmonary bypass in infants: prospective randomised trial
    Medical condition: Regulation of COP during CPB in infants
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-000221-39 Sponsor Protocol Number: M15-539 Start Date*: 2017-12-14
    Sponsor Name:AbbVie Inc
    Full Title: A Prospective, International, Multicenter, Open-Label, Non-Controlled Study of Safety and Effectiveness of Palivizumab, in Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infectio...
    Medical condition: Severe Respiratory Syncytial Virus (RSV) Infection
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-003516-29 Sponsor Protocol Number: KKSK-251 Start Date*: 2006-08-18
    Sponsor Name:Universität zu Köln
    Full Title: Prospective, randomized, double-blinded clinical trial on remifentanil for analgesia and sedation of ventilated neonates and infants
    Medical condition: Meanwhile it is widely accepted, that ventilated newborns and infants should receive analgesia and sedation for ethical and medical reasons. In this context fentanyl belongs to the mosten often use...
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-003402-29 Sponsor Protocol Number: vitA Start Date*: 2005-10-21
    Sponsor Name:Greater Glasgow NHS Board, Yorkhill Division
    Full Title: Does additional vitamin A supplementation improve retinal function and conjunctival health in very low birth weight infants?
    Medical condition: Presumed vitamin A deficiency in preterm infants
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-002146-33 Sponsor Protocol Number: PSK00008 Start Date*: 2021-10-04
    Sponsor Name:Sanofi Pasteur Inc.
    Full Title: Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine when Administered Concomitantly with Routine Pediatric Vaccines in Healthy Toddlers and Infants
    Medical condition: Pneumococcal infection
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10069578 Pneumococcal immunisation PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-002812-24 Sponsor Protocol Number: Start Date*: 2007-10-15
    Sponsor Name:AKH Wien, Universitätsklinik für Physikalische Medizin und Rehabilitation
    Full Title: Behandlung mit Botulinum Toxin A bei Kindern mit Morbus Perthes (Treatment with Botulinum Toxin A in Infants with Perthes Disease)
    Medical condition: therapy-resistent reduction of range of motion in infants with perthes disease
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-001986-34 Sponsor Protocol Number: T151/2019 Start Date*: 2019-11-19
    Sponsor Name:Turku University Hospital
    Full Title: Exploring the impact of pertussis immunization during pregnancy on the differences in immune response of infants after primary immunization with an acellular pertussis containing vaccine: an open l...
    Medical condition: Pertussis Infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10034738 Pertussis PT
    Population Age: In utero, Newborns, Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-003140-56 Sponsor Protocol Number: D200 Probørn Start Date*: 2006-02-10
    Sponsor Name:Department of Human Nutrition, The Royal Veterinary and Agricultural University
    Full Title: Probiotics to infants with atopic dermatitis; an investigation of the effect on eczema, immune system and intestinal microflora, inflammation and permeability. DK-titel Probiotiske bakterier til ...
    Medical condition: Infants participating in the clinical trial are suffering from atopic dermatitis
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-003293-18 Sponsor Protocol Number: RGHT000470 Start Date*: 2009-03-16
    Sponsor Name:Belfast Health and Social Care Trust [...]
    1. Belfast Health and Social Care Trust
    2. Queen's University Belfast
    Full Title: Pharmacokinetics of ketamine in infants
    Medical condition: Pharmacokinetics of ketamine in infants
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021723 Induction and maintenance of anaesthesia LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-005495-19 Sponsor Protocol Number: pro.LISA_01_21 Start Date*: 2022-01-19
    Sponsor Name:University Hospital Schleswig-Holstein
    Full Title: A randomized controlled trial in preterm infants comparing prophylactic with selective “Less Invasive Surfactant Administration” (PRO-LISA)
    Medical condition: Respiratory distress syndrome of premature infants
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-005091-26 Sponsor Protocol Number: SANNI-project:02 Start Date*: 2018-02-13
    Sponsor Name:Skåne University Hospital
    Full Title: Clonidine for analgesia to preterm infants during neonatal intensive care – a prospective pharmacokinetic/pharmacodynamic/pharmacogenetic observational study. Cohort 2 in The SANNI project.
    Medical condition: Sick preterm infants undergoing neonatal intensive care.
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002470-20 Sponsor Protocol Number: SANNI-project:01 Start Date*: 2017-04-11
    Sponsor Name:Skåne University Hospital
    Full Title: Fentanyl and Clonidine for analgesia during hypothermia in term asphyxiated infants – a prospective pharmacokinetic/ pharmacodynamic/ pharmacogenetic observational study. Cohort 1 in The SANNI proj...
    Medical condition: Infants with induced hypothermic treatment after perinatal asphyxia
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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