Video Recording in the Delivery Room in Very Preterm Infants (Video Apgar Trial)
A video of the delivery room management will be taken using standardized conditions. The video will be evaluated either locally by those directly involved in the delivery room care of this specific infant or anonymously at the main study center. Using a standardized evaluation form a set of predefined interventions is rated regarding at what time they took place and at what time they should have taken place. The difference in time for all interventions is summed up to a score. This score should allow to assess the delivery room management in comparison to the desired standard as well as between hospitals. The evaluation forms of all centers will be analyzed at the main study center to define correlations between certain delivery room interventions and short term outcome.
Aim of the study is to
- gather data on how delivery room care is currently done,
- come closer to an agreement between different NICUs towards what should be done in the delivery room under what circumstances in which way,
- find those interventions with potential influence on short term outcome. Those aspects of management that are different between centers and show correlation with short term outcome will be the focus of future prospective intervention trials in order to find the best way how to take care of preterm infants in the delivery room.
Hypothesis:
In preterm infants <32;0 weeks of gestational age a correlation exists between specific delivery room interventions and short term outcome.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Delivery room interventions measured are: Stimulation, Ventilation, Oxygen, Cardiac massage, Suctioning, ven / art access, fluid and drugs given
Short term outcome measurements are: IVH, PVL, Pneumothorax, BPD, DOL when first time 120mL/kg oral feeds, NEC, ROP, death, Head circumference at discharge
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Greifswald, Allemagne, 17475
- Recrutement
- University Children's Hospital
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Contact:
- Helmut Küster, MD
- Numéro de téléphone: -49-3834-86-22476
- E-mail: kuester@uni-greifswald.de
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- preterm infants <32;0 weeks of gestational age
Exclusion Criteria:
- Infants in whom no life support is being planned - e.g. those with lethal malformations
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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The Delivery Room Management Score (DRMS) negatively correlates with short term outcome (none of (death, IVH °3 or 4, PVL, pneumothorax, BPD, NEC °2 or 3, ROP °3 to 5))
Délai: Outcome is measured at first discharge from your hospital
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On special request by the PRS-Team: this is any time between 1 Minute of life in case of delivery room death and up to 2 and more years in case of several complications during the hospital stay.
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Outcome is measured at first discharge from your hospital
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Helmut Küster, MD, University Children's Hospital of Greifswald, Germany
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 123456789 (Bandirma Onyedi Eylul University)
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