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Clinical trials for Apnea of prematurity

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    7 result(s) found for: Apnea of prematurity. Displaying page 1 of 1.
    EudraCT Number: 2015-003274-32 Sponsor Protocol Number: 2015/233 Start Date*: 2016-07-13
    Sponsor Name:Dra Maria Luz Couce [...]
    1. Dra Maria Luz Couce
    2. Dr. José Luis Fernández Trisac
    Full Title: Effect of caffeine citrate in acute bronchiolitis symptoms of apnea in neonates and infants during the first three months of life
    Medical condition: Children under 3 years with acute RSV bronchiolitis which present breaks apnea
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-003666-41 Sponsor Protocol Number: MEC2020-0078 Start Date*: 2020-04-21
    Sponsor Name:Erasmus MC University Medical Center
    Full Title: Doxapram versus placebo in preterm newborns: an international double blinded multicenter randomized controlled trial.
    Medical condition: Preterm infants are at high risk of respiratory failure due to immaturity of the respiratory system. Respiratory failure is caused by a comprised lung function and impaired control of breathing. Co...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077323 Infantile mixed apnea LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-005568-24 Sponsor Protocol Number: NL47657-044-14 Start Date*: 2014-05-28
    Sponsor Name:Medisch Spectrum Twente
    Full Title: The reduction of Apneas in Preterm Infants: Low-Flow versus Caffeine
    Medical condition: Apnea Of Prematurity
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-010381-30 Sponsor Protocol Number: 2.4 Start Date*: 2009-03-19
    Sponsor Name:Isala klinieken
    Full Title: Aerosolised salbutamol in two doses as a treatment for preterm infants with developing bronchopulmonary dysplasia.
    Medical condition: Preterm infants developing bronchopulmonary dysplasia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10006475 Bronchopulmonary dysplasia LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-023668-42 Sponsor Protocol Number: CRI 102194 Start Date*: 2011-02-03
    Sponsor Name:Southampton University Hospital NHS Trust
    Full Title: Pulmonary surfactant (S) biology in ventilated children on a paediatric intensive care unit with acute (A) hypoxic respiratory (R) failure- a pilot (P) study (S): (SARPS)
    Medical condition: acute hypoxic respiratory failure in children ventilated on paediatric intensive care
    Disease: Version SOC Term Classification Code Term Level
    12.1 10040047 Sepsis PT
    12.1 10018985 Haemorrhage intracranial PT
    12.1 10006093 Bradycardia PT
    12.1 10021097 Hypotension PT
    12.1 10006475 Bronchopulmonary dysplasia PT
    12.1 10035759 Pneumothorax PT
    12.1 10037394 Pulmonary haemorrhage PT
    12.1 10058490 Hyperoxia PT
    12.1 10011705 Cyanosis neonatal PT
    12.1 10002974 Apnoea PT
    12.1 10033318 Oxygen saturation decreased PT
    12.1 10014408 Electroencephalogram abnormal PT
    12.1 10063349 Endotracheal intubation complication PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2011-000811-23 Sponsor Protocol Number: Start Date*: 2012-06-22
    Sponsor Name:University Hospital Southampton NHS Foundation Trust
    Full Title: Treatment of neonatal chronic lung disease (nCLD). The Surfactant, Nutrition and Microorganism Interactions study in infants at risk of developing chronic lung disease - 2 (TSuNaMI-II)
    Medical condition: neonatal chronic lung disease bronchopulmonary dysplasia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10022117 - Injury, poisoning and procedural complications 10063349 Endotracheal intubation complication PT
    14.1 10042613 - Surgical and medical procedures 10044107 Total parenteral nutrition LLT
    14.1 10029205 - Nervous system disorders 10018985 Haemorrhage intracranial PT
    14.1 10021881 - Infections and infestations 10069719 Bacterial colonisation LLT
    14.1 10047065 - Vascular disorders 10021097 Hypotension PT
    14.1 10007541 - Cardiac disorders 10006093 Bradycardia PT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10002974 Apnoea PT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037395 Pulmonary haemorrhage of fetus or newborn LLT
    14.1 10021881 - Infections and infestations 10040047 Sepsis PT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10035759 Pneumothorax PT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10058490 Hyperoxia PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2012-001849-41 Sponsor Protocol Number: DOX-101 Start Date*: 2012-06-18
    Sponsor Name:Leids Universitair Medisch Centrum (LUMC)
    Full Title: Two-part, Randomized, Placebo-controlled, Repeated Stepped Infusion Dose Study of the Pharmacodynamics of Doxapram when Co-administered with Opioids (Protocol – doxapram-101).
    Medical condition: acute respiratory insufficiency, including such conditions as opioid and anesthetic-induced respiratory depression, post-anesthetic atelectasis, and central apneas (e.g., apnea of prematurity).
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10038738 Respiratory, thoracic and mediastinal disorders SOC
    Population Age: Adults Gender: Male
    Trial protocol: NL (Ongoing)
    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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