Clinical trial NCT01420107: Video Recording in the Delivery Room in Very Preterm Infants (Video Apgar Trial)
Official title: Video Recording in the Delivery Room in Very Preterm Infants (Video Apgar Trial)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Birth
Keywords: Infant, Premature
Delivery Rooms
Video Recording
Outcome Assessment (Health Care)
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Technische Universität Dresden
First posted: 2011-08-19
Enrollment: 200
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: preterm infants \<32;0 weeks of gestational age

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: 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))
timeFrame: Outcome is measured at first discharge from your hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Children's Hospital
Study officials:
affiliation: University Children's Hospital of Greifswald, Germany
name: Helmut Küster, MD
role: PRINCIPAL_INVESTIGATOR
References: