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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University Medicine Greifswald.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Technische Universität Dresden
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT01420107
First received: February 16, 2011
Last updated: August 18, 2011
Last verified: August 2011
  Purpose

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.


Condition
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)

Resource links provided by NLM:


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 ] [ 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.


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

  Eligibility

Ages Eligible for Study:   up to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

preterm infants <32;0 weeks of gestational age

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420107

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

No publications provided

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

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

ClinicalTrials.gov processed this record on July 23, 2014