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

NCT ID: NCT01420107

Last Updated: 2011-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-04-30

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

Conditions

Premature Birth

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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

• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: collaborator

University Medicine Greifswald

OTHER

Sponsor Role: lead

Responsible Party

University Children's Hospital, Greifswald

Principal Investigators

Helmut Küster, MD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital of Greifswald, Germany

Locations

University Children's Hospital

Greifswald, , Germany

Site Status: RECRUITING

Countries

Germany

Facility Contacts

Helmut Küster, MD

Role: primary

kuester@uni-greifswald.de

-49-3834-86-22476

Other Identifiers

123456789

Identifier Type: -

Identifier Source: org_study_id