Video Recording in the Delivery Room in Very Preterm Infants (Video Apgar Trial)
Recruitment status was: Recruiting
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.
In preterm infants <32;0 weeks of gestational age a correlation exists between specific delivery room interventions and short term outcome.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Video Recording in the Delivery Room in Very Preterm Infants (Video Apgar Trial)|
- 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)) [ Time Frame: Outcome is measured at first discharge from your hospital ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||April 2012|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420107
|University Children's Hospital|
|Greifswald, Germany, 17475|
|Principal Investigator:||Helmut Küster, MD||University Children's Hospital of Greifswald, Germany|