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Clinical trials for Newborn screening

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   44335   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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    48 result(s) found for: Newborn screening. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2017-004958-42 Sponsor Protocol Number: MOM-M281-003 Start Date*: 2019-01-11
    Sponsor Name:Momenta Pharmaceuticals, Inc.
    Full Title: A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease ...
    Medical condition: Early onset Severe Hemolytic Disease of the fetus and newborn (HDFN)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10019512 Hemolytic disease due to Rh isoimmunization of fetus or newborn LLT
    Population Age: In utero, Under 18, Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) NL (Completed) SE (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-016248-37 Sponsor Protocol Number: A1481276 Start Date*: 2010-07-15
    Sponsor Name:Pfizer Ltd., Ramsgate Road, Sandwich, Kent. CT13 9NJ UNITED KINGDOM
    Full Title: A SINGLE ARM SINGLE CENTRE STUDY TO INVESTIGATE SAFETY AND EFFICACY OF SILDENAFIL IN NEAR TERM AND TERM NEWBORNS WITH PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN)
    Medical condition: Persistent pulmonary hypertension of the newborn (PPHN)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10053592 Newborn persistent pulmonary hypertension LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-002619-24 Sponsor Protocol Number: A1481316 Start Date*: 2013-03-04
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A MULTI-CENTRE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, TWO-ARMED, PARALLEL GROUP STUDY TO EVALUATE EFFICACY AND SAFETY OF IV SILDENAFIL IN THE TREATMENT OF NEONATES WITH PERSISTENT PULMONA...
    Medical condition: Persistent pulmonary hypertension of the newborn
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053592 Newborn persistent pulmonary hypertension LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) SE (Completed) ES (Prematurely Ended) AT (Completed) DE (Completed) NO (Completed) IT (Completed) NL (Completed) DK (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-002696-34 Sponsor Protocol Number: 150/2020 Start Date*: 2021-07-19
    Sponsor Name:University of Oulu
    Full Title: Prevention Of Group G/C Streptococcus Infections during labour and postpartum - a randomized controlled multicenter trial (POGSI)
    Medical condition: Participants are pregnant women found to carry group G or C Streptococcus as part of their vaginal-rectal flora in the late pregnancy vaginal-rectal culture routinely taken as GBS screening
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10004038 Bacterial infection due to streptococcus, group C LLT
    20.1 100000004862 10004040 Bacterial infection due to streptococcus, group G LLT
    Population Age: Adults Gender: Female
    Trial protocol: FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-004478-80 Sponsor Protocol Number: Issue1 Start Date*: 2014-01-08
    Sponsor Name:University Hospital Bristol NHS Foundation Trust
    Full Title: XENON AND COOLING THERAPY IN BABIES AT HIGH RISK OF BRAIN INJURY FOLLOWING POOR CONDITION AT BIRTH: A RANDOMISED OUTCOME STUDY (COOLXENON3 STUDY)
    Medical condition: Neonatal hypoxia-ischaemia (HI). There is no exact MedDRA term for this. The closest MedDRA terms matching this are neonatal asphyxia and neonatal hypoxia.
    Disease: Version SOC Term Classification Code Term Level
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    16.1 100000004868 10028946 Neonatal hypoxia and asphyxia HLT
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10050081 Neonatal hypoxia PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2013-003215-21 Sponsor Protocol Number: DGD-44-063 Start Date*: Information not available in EudraCT
    Sponsor Name:GUERBET
    Full Title: DOTAREM® Pharmacokinetics, Safety and Efficacy Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)
    Medical condition: Pediatric subject aged <2 years (term newborn infants to toddlers 23 months of age inclusive) scheduled to undergo routine gadolinium-enhanced Magnetic Resonance Imaging of any body region
    Disease: Version SOC Term Classification Code Term Level
    16.1 10022891 - Investigations 10058644 Nuclear magnetic resonance imaging whole body PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) HU (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-005397-34 Sponsor Protocol Number: Issue1 Start Date*: 2012-02-24
    Sponsor Name:University Hospital Bristol NHS Foundation Trust
    Full Title: Xenon and cooling therapy in babies at high risk of brain injury following poor condition at birth: Randomised pilot study. (CoolXenon2 study)
    Medical condition: Neonatal hypoxia-ischaemia (HI). There is no exact MedDRA term for this. The closest MedDRA terms matching this are neonatal asphyxia and neonatal hypoxia.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10050081 Neonatal hypoxia PT
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10028946 Neonatal hypoxia and asphyxia HLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-017434-45 Sponsor Protocol Number: 64,185-202 Start Date*: Information not available in EudraCT
    Sponsor Name:InfaCare Pharmaceutical Corporation
    Full Title: A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates with Hyperbilirubinemia
    Medical condition: Neonatal hyperbilirubinemia Hiperbilirubinemia neonatal
    Disease: Version SOC Term Classification Code Term Level
    14.0 10019805 - Hepatobiliary disorders 10020580 Hyperbilirubinaemia neonatal PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-002215-26 Sponsor Protocol Number: M13-563 Start Date*: 2013-07-18
    Sponsor Name:Abbott Laboratories GmbH
    Full Title: A Double-Blind, Double-Dummy, Randomized, Two-arm, Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg daily versus Intravaginal Micronized Progesterone C...
    Medical condition: Female infertility
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004865 10003540 Assisted fertilization LLT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed) AT (Completed) ES (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2022-000382-41 Sponsor Protocol Number: PFL2021 Start Date*: 2022-10-05
    Sponsor Name:Reproducción Bilbao. Ginegorama S.L.
    Full Title: Protection of the luteal phase by means of progesterone in assisted reproduction procedures. Comparison of different routes of administration and study of predictive parameters of reproductive succ...
    Medical condition: In this project, we propose the performance of a comparative study of different patterns of gestagenic coverage in in vitro fertilization (IVF) cycles with deferred transfer of genetically selected...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-003913-36 Sponsor Protocol Number: REFSAL Start Date*: Information not available in EudraCT
    Sponsor Name:Warszawski Uniwersytet Medyczny
    Full Title: Evaluation of frequency occurrence persistent pulmonary hypertension of newborns in group of newborns born between 32 and 42 weeks of pregnancy treated by salbutamol
    Medical condition: Persistent pulmonary hypertension of newborns in group of newborns born between 32 and 42 weeks of pregnancy
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2023-001028-40 Sponsor Protocol Number: RIV-PN-201 Start Date*: 2024-01-15
    Sponsor Name:United Therapeutics Corp
    Full Title: Intravenous Remodulin (Treprostinil) as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn: A Randomized, Placebo-Controlled, Safety and Efficacy Study
    Medical condition: Persistant Pulmonary Hypertension of the Newborn (PPHN)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-003949-32 Sponsor Protocol Number: A6281287 Start Date*: 2007-12-21
    Sponsor Name:Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
    Full Title: A two-year multi-centre, randomized two arm study of Genotropin treatment in very young children born small for gestational age: Early Growth and Neurodevelopment (EGN)
    Medical condition: Short Stature children born small for Gestational Age (SGA)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10041093 Small for gestational age LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) CZ (Completed) BE (Completed) ES (Completed) AT (Completed) GB (Completed) FR (Completed) IT (Completed) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2021-003777-63 Sponsor Protocol Number: 202100482 Start Date*: Information not available in EudraCT
    Sponsor Name:University Medical Center Groningen
    Full Title: Tetrahydrobiopterin (BH4) treatment in Phenylketonuria - comparing different practices of dosing regimen
    Medical condition: Phenylketonuria (PKU; OMIM 261600)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-020840-36 Sponsor Protocol Number: V98_04 Start Date*: 2011-08-08
    Sponsor Name:Novartis Vaccines and Diagnostics GmbH
    Full Title: A Phase II Randomized, Observer-Blind, Multi-Center, Controlled Study of a Trivalent group B Streptococcus Vaccine in Healthy Pregnant Women
    Medical condition: Invasive group B streptococcus disease
    Disease: Version SOC Term Classification Code Term Level
    13.1 10021881 - Infections and infestations 10053588 Group B streptococcus neonatal sepsis PT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-002962-19 Sponsor Protocol Number: SKA 001 Start Date*: 2011-10-04
    Sponsor Name:University College Dublin
    Full Title: CHLORHEXIDINE VERSUS POVIDONE-IODINE FOR SKIN ANITSEPSIS PRIOR TO CENTRAL VENOUS CATHETER INSERTION IN PRETERM INFANTS: PROTOCOL FOR A RANDOMISED TRIAL (THE SKA TRIAL)
    Medical condition: Blood stream infections in neonates
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2020-002726-84 Sponsor Protocol Number: SHP607-203 Start Date*: Information not available in EudraCT
    Sponsor Name:Premacure AB
    Full Title: Long-Term Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment with SHP607 in Extremely Premature Infants
    Medical condition: Chronic Lung Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10066204 Chronic lung disease of prematurity LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-003136-25 Sponsor Protocol Number: CTD-TCNPC-301 Start Date*: 2021-10-25
    Sponsor Name:Cyclo Therapeutics, Inc.
    Full Title: A Phase 3, Double blind, Randomized, Placebo controlled, Parallel group, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of 2000 mg/kg of Trappsol® Cyclo™ (Hydroxypropyl β cycl...
    Medical condition: Niemann Pick Disease Type C1
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10029403 Niemann-Pick disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Ongoing) DE (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-004692-19 Sponsor Protocol Number: 963 Start Date*: 2007-12-19
    Sponsor Name:Biotest AG
    Full Title: Prevention of congenital cytomegalovirus infection in infants of mothers with primary cytomegalovirus infection during pregnancy. A randomised, open, controlled, multicentre and multinational study...
    Medical condition: Congenital CMV infection after primary CMV infection during pregnancy
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10010420 Congenital CMV infection LLT
    Population Age: In utero, Newborns, Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) HU (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-021343-41 Sponsor Protocol Number: ME040 Start Date*: 2014-03-21
    Sponsor Name:University Medical Center Groningen
    Full Title: Effect of sapropterin on variations of blood phenylalanine and tyrosine over 24 hours and from day to day in children with phenylketonuria
    Medical condition: Phenylketonuria (PKU) is an autosomal recessive metabolic genetic disorder by a mutation in the gene for the enzyme phenylalanine hydroxylase (PAH), rendering it nonfunctional. Left untreated, the ...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
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