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Video Recording in the Delivery Room in Very Preterm Infants (Video Apgar Trial)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by University Medicine Greifswald.
Recruitment status was:  Recruiting
Technische Universität Dresden
Information provided by:
University Medicine Greifswald Identifier:
First received: February 16, 2011
Last updated: August 18, 2011
Last verified: August 2011

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.

Premature Birth

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Video Recording in the Delivery Room in Very Preterm Infants (Video Apgar Trial)

Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • 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 ]
    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.

Estimated Enrollment: 200
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)
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


Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
preterm infants <32;0 weeks of gestational age

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01420107

University Children's Hospital Recruiting
Greifswald, Germany, 17475
Contact: Helmut Küster, MD    -49-3834-86-22476   
Sponsors and Collaborators
University Medicine Greifswald
Technische Universität Dresden
Principal Investigator: Helmut Küster, MD University Children's Hospital of Greifswald, Germany
  More Information

Responsible Party: Helmut Küster, MD, University Children's Hospital, Greifswald Identifier: NCT01420107     History of Changes
Other Study ID Numbers: 123456789
Study First Received: February 16, 2011
Last Updated: August 18, 2011

Keywords provided by University Medicine Greifswald:
Infant, Premature
Delivery Rooms
Video Recording
Outcome Assessment (Health Care)

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications processed this record on September 20, 2017