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

NCT01420107 | Unknown DMC

• 1 other identifier: 123456789
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

Infant, Premature; Delivery Rooms; Video Recording; Outcome Assessment (Health Care)

Outcome Measures

Primary Outcomes (1)

• 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))

  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.

  Outcome is measured at first discharge from your hospital

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

preterm infants \<32;0 weeks of gestational age

You may qualify if:

• preterm infants \<32;0 weeks of gestational age

You may not qualify if:

• Infants in whom no life support is being planned - e.g. those with lethal malformations

Sponsors & Collaborators

• University Medicine Greifswald: lead
• Technische Universität Dresden: collaborator

Study Sites (1)

University Children's Hospital

Greifswald, 17475, Germany

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Helmut Küster, MD

  University Children's Hospital of Greifswald, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: August 19, 2011
• Study Start: August 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2012
• Last Updated: August 19, 2011

Record last verified: 2011-08

Locations

DE (1)