- Trials with a EudraCT protocol (474)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (20)

These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. |
Study title: Ambroxol in hyaline membrane disease. |
Active substance: AMBROXOL |
Study summary document link (including results): Ambroxol Hydrochloride_U90-0228_Synopsis.pdf |
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Document reference: 46545 |
Study title: Effects of endotracheal and intravenous administration of Ambroxol (NA-872) on the clinical course of hyaline membrane disease. |
Active substance: AMBROXOL |
Study summary document link (including results): Ambroxol Hydrochloride_U84-0675_Synopsis.pdf |
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Document reference: 46527 |
Study title: Bucci G, Cook CD. Studies of respiratory physiology in children. VI. Lung diffusing capacity, diffusing capacity of the pulmonary membrane and pulmonary capillary blood volume in congenital heart disease. J Clin Invest 1961 Aug;40(8 Pt 1-2):1431-41.Bucci G, Cook CD. Studies of respiratory physiology in children. VI. Lung diffusing capacity, diffusing capacity of the pulmonary membrane and pulmonary capillary blood volume in congenital heart disease. J Clin Invest 1961 Aug;40(8 Pt 1-2):1431-41. |
Active substance: CARBON MONOXIDE HELIUM OXYGEN |
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Document reference: 23360 |
Study title: Antimicrobial therapy in preterm premature rupture of membranes: results of a prospective, double−blind, placebo−controlled trial of erythromycin. McGregor JA, French JI, Seo K. American journal of obstetrics and gynecology, Sep 1991, vol. 165, no. 3, p 632−40. |
Active substance: ERYTHROMYCIN |
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Document reference: 26487 |
Study title: Erytromycine bij prematuur gebroken vliezen gunstig voor de gezondheid van het kind. (Erythromycin for premature rupture of membranes is beneficial for infant).Buitendijk S E. Nederlands tijdschrift voor geneeskunde, {Ned Tijdschr Geneeskd}, 22 Sep 2001, vol. 145, no. 38, p.1828 31 |
Active substance: ERYTHROMYCIN |
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Document reference: 26429 |
Study title: ORACLE antibiotics for preterm prelabour rupture of the membranes: short term and long term outcomes. Kenyon S, Taylor D J, Tarnow Mordi W O. Acta paediatrica (Oslo Norway : 1992). Supplement, 2002, vol. 91, no. 437, p.12 5 |
Active substance: ERYTHROMYCIN |
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Document reference: 26426 |
Study title: Bucci G, Cook CD. Studies of respiratory physiology in children. VI. Lung diffusing capacity, diffusing capacity of the pulmonary membrane and pulmonary capillary blood volume in congenital heart disease. J Clin Invest 1961 Aug;40(8 Pt 1-2):1431-41.Bucci G, Cook CD. Studies of respiratory physiology in children. VI. Lung diffusing capacity, diffusing capacity of the pulmonary membrane and pulmonary capillary blood volume in congenital heart disease. J Clin Invest 1961 Aug;40(8 Pt 1-2):1431-41. |
Active substance: HELIUM AND OXYGEN |
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Document reference: 29070 |
Study title: Lochan S.R. et al., Coadministration of theophylline enhances diuretic response to furosemide in infants during extracoproreal membrane oxygenation:a a randomized controlled pilot study; J.Pediatr. 133, 86-89(1998)Lochan S.R. et al., Coadministration of theophylline enhances diuretic response to furosemide in infants during extracoproreal membrane oxygenation:a a randomized controlled pilot study; J.Pediatr. 133, 86-89(1998) |
Active substance: FUROSEMIDE |
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Document reference: 28636 |
Study title: Safety and Immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (TdcP) Vaccine Compared to Tetanus and Diphtheria Toxoids Adsorbed (Td) in Adolescents and Adults 11-64 Years of Age |
Active substance: purif tetan toxoid,purif dipht toxoid,purif pert toxoid,purif filamentous haemaggl,purif fimbriae (agglutinogens 2 & 3),purif pertactin (69kda membrane protein)-inact polio vacc |
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Document reference: 41432 |
Study title: Safety of four acellular pertussis combination vaccines (Infantrix-IPV, Boostrix, Covaxis and repevax) given a booster dose to six-year-old Finnish children |
Active substance: purif tetan toxoid,purif dipht toxoid,purif pert toxoid,purif filamentous haemaggl,purif fimbriae (agglutinogens 2 & 3),purif pertactin (69kda membrane protein)-inact polio vacc |
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Document reference: 41433 |
Study title: Wells TG, Heulitt MJ, Taylor BJ, Fasules JW, Kearns GL. Pharmacokinetics and pharmacodynamics of ranitidine in neonates treated with extracorporeal membrane oxygenation. J Clin Pharmacol. 1998 May;38(5):402-7.Wells TG, Heulitt MJ, Taylor BJ, Fasules JW, Kearns GL. Pharmacokinetics and pharmacodynamics of ranitidine in neonates treated with extracorporeal membrane oxygenation. J Clin Pharmacol. 1998 May;38(5):402-7. |
Active substance: RANITIDINE |
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Document reference: 35280 |
Study title: DRUG TREATMENT VERSUS EXPECTANT MANAGEMENT OF PRETERM PREMATURE RUPTURE OF MEMBRANES |
Active substance: SULBACTAM |
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Document reference: 42652 |
Study title: Use of Octenisept for pre-operative skin and mucous membrane antisepsis and for supportive wound and suture treatment in small children and babies. UNIV-KLINIK FUR CHIRURGIE.1998. |
Active substance: OCTENIDINE |
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Document reference: 32737 |
Study title: UK Collaborative ECMO Trial Group. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation. Lancet 1996; 348: 75-82UK Collaborative ECMO Trial Group. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation. Lancet 1996; 348: 75-82 |
Active substance: OXYGEN |
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Document reference: 45413 |
Study title: A PLACEBO-CONTROLLED DOUBLE-BLIND PROSPECTIVE STUDY OF THE EFFICACY OF UNASYN IN MANAGING PRETERM PREMATURE RUPTURE OF THE MEMBRANES |
Active substance: SULBACTAM |
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Document reference: 42663 |
Study title: AMPICILLIN/SULBACTAM VERSUS PLACEBO FOR THE INHIBITION OF PREMATURE LABOR OF PATIENTS ON TOCOLYSIS AND IN THE PROLONGATION OF THE LATENT PERIOD AFTER PREMATURE RUPTURE OF THE FETAL MEMBRANES |
Active substance: SULBACTAM |
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Document reference: 42650 |
Study title: UK Collaborative ECMO Trial Group. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation. Lancet 1996; 348: 75-82UK Collaborative ECMO Trial Group. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation. Lancet 1996; 348: 75-82 |
Active substance: OXITRIPTAN |
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Document reference: 32950 |
Study title: Surgical repair of congenital diaphragmatic hernia during extracorporeal membrane oxygenation: hemorrhagic complications and the effect of tranexamic acid. J Pediatr Surg. 1997 Apr;32(4):594-9Surgical repair of congenital diaphragmatic hernia during extracorporeal membrane oxygenation: hemorrhagic complications and the effect of tranexamic acid. J Pediatr Surg. 1997 Apr;32(4):594-9 |
Active substance: TRAXENAMIC ACID |
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Document reference: 46718 |
Study title: An open, prospective study to investigate the respiratory membrane permeability to plasma proteins and its relatio to bronchial hyperreactivity. In addition, the effect of therapy with inhaled glucocorticosteroids in 14 patients with stable bronchial asthma and eight healthy volunteers (range, 16 to 68 yr). |
Active substance: BUDESONIDE |
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Document reference: 48418 |
Study title: B. Romański - ,,Comparative clinical trial of the prep. Xylogel 0.05% and 0.1% in the form of nasal gel and Xylometazolin 0.05% and 0.1% in the form of nasal drops manufactured by WPW Polfa in patients with rhinitis of nose mucous membrane" |
Active substance: XYLOMETAZOLINE |
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Document reference: 45637 |