Trials / Unknown
UnknownNCT01420107
Video Recording in the Delivery Room in Very Preterm Infants (Video Apgar Trial)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- University Medicine Greifswald · Academic / Other
- Sex
- All
- Age
- 32 Weeks
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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
Conditions
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2011-12-01
- Completion
- 2012-04-01
- First posted
- 2011-08-19
- Last updated
- 2011-08-19
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01420107. Inclusion in this directory is not an endorsement.