Randomized trial of rG-CSF (Neupogen) versus Placebo to prevent of the premature nosocomial infections in neutropenic preterm infants
| DEC-NET Serial number FR511 | |
| Published online | 02/11/2005 14.10.00 |
| Last updated | 22/06/2006 15.19.25 |
| Other protocol ID number | PHRC N° 2712 |
| Current trial status | Open (actively recruiting new participants) |
| Major Disease (ICD9 class) | Other infection specific to the perinatal period. Incl. Septicemia [sepsis] of newborn |
| Experimental drug | |
| rG-CSF Filgrastim | |
| Gender | Both |
| Age (range) | <33-36 weeks of gestation age |
Eligibility criteria | |
| Inclusion criteria | |
| -Infant of less than 33 weeks or less than 36 weeks and less than 1500 g - Having less than 1500 PNN/mm3 during the first 3 weeks for at least 24 hours. -Written informed consent. | |
| Exclusion criteria | |
| -Neutropenia related with a ongoing bacterial infection (materno foetal or secondary infections or related to a viral foetopathy). -Infant with major malformation -Infant with life threatening neurological anomalies | |
Trial design/methodology | |
| Phase | 3 |
| Kind of study | Efficacy Prophylaxis |
| Design | Controlled Randomised Blinded Double blind |
| Purpose of study | |
| To correct the neutropenia of premature infants during the first 3 weeks of life by the administration of rG-CSF (Neupogen) and thus to reduce the appearance of nosocomial infections. | |
| Primary outcomes | |
| To decrease the number of nocosomial infections during the first weeks of life | |
| Secondary outcomes | |
| - | |
| Summary of study design, objectives, and ongoing research findings | |
| Multicentric, randomized,double blinded study of rG-csf (Neupogen) versus placebo, evaluating the effect of the rG-csf (Neupogen) to prevent the occurrence of early nosocomial infections in neutropenic extreme premature infant (<1500 neutrophiles/mm3 during at least 24 hours)during the first days of life. | |
| Principal investigator | |
| Name | Pr. Jean MESSER |
| Institution | Hôpital de hautepierre, Service de Pédiatrie 2 |
| Postal address | Avenue molière F-67098 Strasbourg |
| City | Strasbourg |
| Country | FRANCE |
| Phone | 00(33)(0)3.88.12.77.74 |
| Fax | 00(33)(0)3.88.12.71.32 |
| Promoter |
| CHU Strasbourg (University) |
| Participating centres |
| CHU Grenoble (Grenoble) |
| CHU Angers (Angers) |
| Hôpital de la Côte Basque (Bayonne) |
| CHU St Jacques (Besançon) |
| CHU Hôpital des Enfants (Bordeaux) |
| Hôpital Clémenceau (Caen) |
| CH de Calais (Calais) |
| CHU Hôtel-Dieu (Clermont-Ferrand) |
| Hôpital d'Enfants (Dijon) |
| Hôpital Jeanne de Flandre (Lille) |
| Hôpital Saint-Antoine (Lille) |
| CHU Dupuytren (Limoges) |
| Hôpital Edouard Herriot (Lyon) |
| CH Lyon-Sud (Lyon Pierre-Benite) |
| Hôpital de la Timone-Enfants (Marseille) |
| CH Arnaud de Villeneuve (Montpellier) |
| CH André Grégoire ( Paris Montreuil) |
| CH du Hasenrain (Mulhouse) |
| Maternité Régionale A. Pinard (Nancy) |
| CHRU de Nantes (Nantes) |
| CHU de Nice (Nice) |
| CHU Carémeau (Nîmes) |
| IPRPN (Paris) |
| Hôpital Robert Debré (Paris) |
| Hôpital de Port-Royal (Paris) |
| Hôpital Saint Vincent de Paul (Paris) |
| CH Poissy-Saint Germain (Poissy) |
| CHU Hôpital Jean-Bernard (Poitiers) |
| CH René Dubos (Pontoise) |
| CHU Reims (Reims) |
| CHU Rouen (Rouen) |
| CH la Beauchée (Saint-Brieuc) |
| Hôpital Nord (Saint-Etienne) |
| CHU Purpan (Toulouse) |
| CHRU Tours (Tours) |
| Hôpital Louis Mourier (Colombes) |
| CHI Créteil (Créteil) |
| Hôpital de Lens (Lens) |
| CHR d'Orléans (Orléans) |
| Hôpital Armand Trousseau (Paris) |
| Hôpital Sud (Rennes) |
| CHU Nord (Amiens) |
| ISRCTN | EudraCT |
