- Trials with a EudraCT protocol (200)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (110)
200 result(s) found for: Neonates.
Displaying page 1 of 10.
| EudraCT Number: 2015-000486-31 | Sponsor Protocol Number: HD201 | Start Date*: 2015-05-27 |
| Sponsor Name:Department of Anaesthesiology and Intensive Care, University of Tartu | ||
| Full Title: The effect of milrinone on central and regional blood flow in preterm neonates undergoing patent ductus arteriosus ligation. | ||
| Medical condition: Acute cardiorespiratory deterioration in preterm neonates 6-12 hours after open arterial duct ligation that is called post ligation cardiac syndrome (PLCS). | ||
| Disease: | ||
| Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: EE (Completed) | ||
| Trial results: (No results available) | ||
| EudraCT Number: 2009-011753-41 | Sponsor Protocol Number: 0902-127 | Start Date*: 2010-12-23 |
| Sponsor Name:Neonatal intensive care unit, VU medical center Amsterdam | ||
| Full Title: Pain treatment of newborns: paracetamol rectal versus intraveneous administration, an open randomised clinical trial. | ||
| Medical condition: Pain treatment of neonates and premature neonates. | ||
| Disease: | ||
| Population Age: Preterm newborn infants, Newborns, Under 18 | Gender: Male, Female | |
| Trial protocol: NL (Ongoing) | ||
| Trial results: (No results available) | ||
| 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: 2015-004836-36 | Sponsor Protocol Number: HD202 | Start Date*: 2016-02-03 |
| Sponsor Name:Department of Anaesthesiology and Intensive Care, University of Tartu | ||
| Full Title: Dose dependent effects of dobutamine on central and regional blood flow in preterm and term neonates | ||
| Medical condition: Hypoperfusion status of preterm and term newborns during the first days of life. | ||
| Disease: | ||
| Population Age: Preterm newborn infants, Newborns, Under 18 | Gender: Male, Female | |
| Trial protocol: EE (Prematurely Ended) | ||
| Trial results: (No results available) | ||
| EudraCT Number: 2005-004151-35 | Sponsor Protocol Number: PK-1 | Start Date*: Information not available in EudraCT |
| Sponsor Name:Universität Heidelberg | ||
| Full Title: Pharmacokinetics of oral cefuroxime-axetil compared to intravenous cefuroxime in term neonates and possible adjustment of the oral therapy | ||
| Medical condition: 12 Patients (full term neonates with 7 to 28 days of age) with infections of the skin, the nails or the respiratory tract. | ||
| Disease: | ||
| Population Age: Newborns, Under 18 | Gender: Male, Female | |
| Trial protocol: DE (Ongoing) | ||
| Trial results: (No results available) | ||
| EudraCT Number: 2010-019955-23 | Sponsor Protocol Number: LWH 0852 | Start Date*: 2010-12-29 |
| Sponsor Name:Liverpool Women's NHS Foundation Trust [...] | ||
| Full Title: To evaluate the pharmakcokinetics, tolerability and short term safety of ciprofloxacin in neonates and infants with suspected (or proven) Gram Negative Infection Open Label pilot PK study - TINN T... | ||
| Medical condition: Pharmacokinetics of ciprofloxacin used for suspected or proven gram negative sepsis. | ||
| Disease: | ||
| Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: GB (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2009-013456-76 | Sponsor Protocol Number: roofthooft/paracetamol | Start Date*: 2010-04-22 |
| Sponsor Name: | ||
| Full Title: Pharmakokinetics and Pharmacodynamics of Acetaminophen( paracetamol i.v) in Neonates | ||
| Medical condition: We want to determine the optimal loading dose of intravenous Acetaminophen in neonates of different gestational age subgroups. To this effect a loading dose of 10mg/kg, 15mg/kg or 20mg/kg Acetam... | ||
| Disease: | ||
| Population Age: Preterm newborn infants, Newborns, Under 18 | Gender: Male, Female | |
| Trial protocol: NL (Ongoing) | ||
| Trial results: (No results available) | ||
| EudraCT Number: 2012-001916-41 | Sponsor Protocol Number: C11-11 | Start Date*: 2014-11-24 |
| Sponsor Name:Inserm | ||
| Full Title: Fluconazole versus Micafungin in neonates with suspected or culture-proven Candidiasis: a randomized pharmacokinetic and safety study | ||
| Medical condition: Neonates with suspected or culture-proven candidiasis | ||
| Disease: | ||
| Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: BE (Completed) IT (Prematurely Ended) NL (Completed) ES (Ongoing) | ||
| Trial results: (No results available) | ||
| EudraCT Number: 2010-020103-70 | Sponsor Protocol Number: 1 | Start Date*: 2012-08-14 |
| Sponsor Name:University of Tartu | ||
| Full Title: Pharmacokinetics of intravenous phenobarbital and lidocaine in the treatment of neonatal seizures of term neonates requireing therapeutic hypothermia | ||
| Medical condition: Neonatal seizures | ||
| Disease: | ||
| Population Age: Newborns, Under 18 | Gender: Male, Female | |
| Trial protocol: EE (Prematurely Ended) | ||
| Trial results: (No results available) | ||
| EudraCT Number: 2012-002648-26 | Sponsor Protocol Number: S54472 | Start Date*: 2013-10-16 | ||||||||||||||||||||||||||
| Sponsor Name:UZ Leuven | ||||||||||||||||||||||||||||
| Full Title: Exploratory Propofol Dose Finding Study In Neonates. | ||||||||||||||||||||||||||||
| Medical condition: Investigation of the most effective intravenously administered single propofol dose for successful INSURE prodecure and for (semi-)elective intubation of neonates in non-INSURE conditions (e.g. sur... | ||||||||||||||||||||||||||||
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| Population Age: Preterm newborn infants, Newborns, Under 18 | Gender: Male, Female | |||||||||||||||||||||||||||
| Trial protocol: BE (Completed) | ||||||||||||||||||||||||||||
| Trial results: View results | ||||||||||||||||||||||||||||
| EudraCT Number: 2016-000134-22 | Sponsor Protocol Number: MDCO-CAN-15-01 | Start Date*: 2021-01-14 |
| Sponsor Name:Chiesi Farmaceutici S.p.A. | ||
| Full Title: A Prospective, Open-Label, Single-Arm, Multi-Center Study to Assess The Pharmacokinetics/Pharmacodynamics (PK/PD) AND Safety Of Different Cangrelor Doses In Neonatal Subjects At Risk Of Thrombosis. | ||
| Medical condition: Postoperative neonatal cardiac subjects who are undergoing surgery for placement of systemic-to pulmonary artery palliative shunts (e.g., Blalock-Taussig or central shunt), right ventricle to pulmo... | ||
| Disease: | ||
| Population Age: Newborns, Under 18 | Gender: Male, Female | |
| Trial protocol: Outside EU/EEA | ||
| Trial results: View results | ||
| EudraCT Number: 2004-001841-14 | Sponsor Protocol Number: PICOLO | Start Date*: 2005-01-10 |
| Sponsor Name:SANOFI-SYNTHELABO | ||
| Full Title: Dose-ranging pharmacodynamic assessment of platelet aggregation inhibition with clopidogrel in children of Blalock-Taussig shunt age categories (neonates and infants/toddlers) | ||
| Medical condition: neonates or infants/toddlers at risk of thrombosis | ||
| Disease: | ||
| Population Age: Newborns, Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: IT (Completed) BE (Completed) Outside EU/EEA | ||
| Trial results: View results | ||
| EudraCT Number: 2014-005577-36 | Sponsor Protocol Number: neopopgen_v1.0 | Start Date*: 2015-04-02 |
| Sponsor Name:Teijo Saari | ||
| Full Title: Individualising propofol and oxycodone therapy in neonates using pharmacogenomic profiling, population based modeling and simulations. | ||
| Medical condition: Neonates, who need to be intubated and ventilated with a ventilator. | ||
| Disease: | ||
| Population Age: Preterm newborn infants, Newborns, Under 18 | Gender: Male, Female | |
| Trial protocol: FI (Completed) | ||
| Trial results: (No results available) | ||
| EudraCT Number: 2016-004447-36 | Sponsor Protocol Number: ZonMw848015005 | Start Date*: 2017-06-23 |
| Sponsor Name:Stichting Rotterdams Onderzoeksconsortium Kindergeneeskunde | ||
| Full Title: INTRAVENOUS-TO-ORAL ANTIBIOTIC SWITCH THERAPY FOR SUSPECTED NEONATAL BACTERIAL INFECTIONS: CLINICAL EFFICACY, SAFETY AND COST-EFFECTIVENESS | ||
| Medical condition: Neonatal probable bacterial infection | ||
| Disease: | ||
| Population Age: Preterm newborn infants, Newborns, Under 18 | Gender: Male, Female | |
| Trial protocol: NL (Completed) | ||
| Trial results: (No results available) | ||
| EudraCT Number: 2016-001974-14 | Sponsor Protocol Number: CCD-050000-01 | Start Date*: 2023-08-11 |
| Sponsor Name:Chiesi Farmaceutici S.p.A. | ||
| Full Title: An Open-Label, Multicenter, Randomized, Controlled Study in Spontaneously Breathing Preterm Neonates with Respiratory Distress Syndrome to Compare Two Procedures for Porcine Surfactant (poractant a... | ||
| Medical condition: Treatment of Respiratory Distress Syndrome (RDS) in spontaneously breathing preterm neonates. | ||
| Disease: | ||
| Population Age: Preterm newborn infants, Under 18 | Gender: Male, Female | |
| Trial protocol: Outside EU/EEA | ||
| Trial results: View results | ||
| EudraCT Number: 2008-008012-98 | Sponsor Protocol Number: sl2008-1 | Start Date*: 2009-12-18 |
| Sponsor Name:Stefan Lundeberg | ||
| Full Title: Pharmacokinetic study of the opioid ketobemidone in neonates after an intravenous administration | ||
| Medical condition: Pain treatment with opioids in children | ||
| Disease: | ||
| Population Age: Newborns, Under 18 | Gender: Male, Female | |
| Trial protocol: SE (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2017-000953-38 | Sponsor Protocol Number: MK-1986-014 | Start Date*: 2018-02-07 | |||||||||||
| Sponsor Name:Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. | |||||||||||||
| Full Title: A Phase 1, Single-and Multiple-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old | |||||||||||||
| Medical condition: Treatment or prophylaxis against Gram-positive infections | |||||||||||||
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| Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||
| Trial protocol: BG (Completed) GB (GB - no longer in EU/EEA) NO (Completed) Outside EU/EEA | |||||||||||||
| Trial results: View results | |||||||||||||
| EudraCT Number: 2010-023155-28 | Sponsor Protocol Number: AGO/2010/006 | Start Date*: 2011-02-14 | |||||||||||
| Sponsor Name:Ghent University Hospital | |||||||||||||
| Full Title: Dexmedetomidine pharmacokinetics-pharmacodynamics in mechanically ventilated neonates with single-organ respiratory failure (NEODEX) | |||||||||||||
| Medical condition: Patients admitted to the neonatal intensive care unit with single-organ respiratory failure | |||||||||||||
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| Population Age: Preterm newborn infants, Newborns, Under 18 | Gender: Male, Female | ||||||||||||
| Trial protocol: BE (Completed) | |||||||||||||
| Trial results: View results | |||||||||||||
| EudraCT Number: 2019-000608-14 | Sponsor Protocol Number: 1.0/170119 | Start Date*: Information not available in EudraCT |
| Sponsor Name:Tartu University Hospital | ||
| Full Title: Prospective validation of individualized Bayesian dose optimization tool DosOpt for Vancomycin treatment in neonates. | ||
| Medical condition: In neonatal population wide inter-and intra-individual variability of pharmacokinetics makes extremely difficult to ensure optimal exposure of vancomycin with standard regimens. On average >50% of ... | ||
| Disease: | ||
| Population Age: Preterm newborn infants, Newborns, Under 18 | Gender: Male, Female | |
| Trial protocol: EE (Ongoing) | ||
| Trial results: (No results available) | ||
| EudraCT Number: 2017-000406-38 | Sponsor Protocol Number: DEX-09-08 | Start Date*: 2017-02-27 |
| Sponsor Name:Hospira Inc | ||
| Full Title: A Phase II/III, Open-Label, Multicenter, Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Neonates Ages ≥ 28 Weeks to ≤ 44 Weeks Gestational Age | ||
| Medical condition: Initially intubated and mechanically ventilated preterm neonates ≥ 28 weeks through < 36 weeks gestational age and term neonates born at ≥ 36 weeks through ≤ 44 weeks gestational age in an intens... | ||
| Disease: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: Outside EU/EEA | ||
| Trial results: View results | ||
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