Quality Study in Neonatal Resuscitation
Background
This is a request to you about participating in a quality study in neonatal resuscitation where we aim
to develop an educational program that will ensure newborns optimal treatment if they require
resuscitation immediately after birth. International guidelines for neonatal resuscitation have a
strong focus on maintaining high quality of care to ensure optimal treatment for newborns. Health
care providers are regularly trained, but we know skills start declining short time after training. Our
goal is to assess frequency and quality of newborn resuscitation in order to develop an educational
program that will ensure best possible outcome for newborns. The study will be conducted at the
delivery departments at Oslo University Hospital, Ullevål.
What does the study involve?
The only way to assess the quality of health care provider performance is to observe how actual
emergencies are handled. We will evaluate the quality of neonatal resuscitation and define
educational needs by video recording events where newborns need assistance after birth. Video
recording is an internationally recognised method used to evaluate and improve quality of care. The
videos will be used to review some events with the health care providers that were present, and will
always be evaluated to identify areas in need of improvement. Education and training can then be
tailored to ensure health care providers perform even better resuscitation to the sickest newborns.
The outcome will be evaluated by assessing performance in both real-life situations and during
simulation training. Additional information about the delivery and the newborns health before,
during and after delivery will be collected from patient records.
Possible benefits or disadvantages for you
You and your baby will not have any direct benefit from participating in this study, but experiences
from this study will increase the knowledge in neonatal resuscitation. There are few disadvantages of
participating in the study except that some may find it discomforting that their baby is video
recorded if it needs resuscitation. Resuscitation is performed in a separate room where advanced
equipment is available; the camera will be placed so that only the newborn, health care workers and
patient monitors are captured. The mother or other family members will not be filmed. The filming
will not be associated with any risk. The providers will always do their best to take care of the
newborn and give the best treatment regardless if the event are video recorded or not.
How will the information about the baby be recorded and stored?
The registered information will only be used for the purposes described for the study. The video
records will be deleted as soon as they have been reviewed, normally within a week and will only
been shown to authorized study personnel. All information will be handled without name, date of
birth/directly identifiable patient information. A coded list will be used to link registered information
to names and date of birth. Only study personnel will have access to the coded list. When publishing
the results of this study, it will not be possible to identify you or your baby. You have the right to see
any information we have registered for you or your baby. The information will be deleted in 2017.
Furthermore, you have the right to have registered information corrected if anything is wrong. If you
wish to withdraw your child from the study, you can have the information deleted. You can also have
the video recording deleted before evaluation. Oslo University Hospital is responsible for all data
handling.
Volunteer participating
Participating in the study is voluntary. If you consent, no further action is necessary. If you do NOT
want your baby to be enrolled in the study, please fill out the exclusion form and bring it along to the
hospital. You do not have to give any reason to why you do not wish to participate, and there will be
no consequences for you or your baby. If you change your mind, you can withdraw from the study at
any time.
If you want more information, contact project manager Theresa Mariero Olasveengen, mobile phone
41419930
Request to be excluded from participating in a quality
study in neonatal resuscitation at Oslo University Hospital,
Ullevål.
This request may be used if you do NOT want your newborn baby to participate in a quality study.
Please give the name and date of birth of the mother and sign the form with name and date.
Name (mother):…………………………………………...
Date of birth(mother):…………………………………
Date: ………………
Signature: ……………………………………………
Bring this form along to the hospital.