Premature Birth Clinical Trial
Official title:
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.
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
;
Observational Model: Case-Only, Time Perspective: Prospective
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