Brief Title
Follow-up Results of Newborns With Tracheostomy
Official Title
Retrospective Evaluation of Follow-up Results of Newborns Who Underwent Tracheostomy
Brief Summary
The chances of survival in premature babies, especially in babies born under 28 weeks, have
increased in recent years, and comorbidities also increase. Bronchopulmonary dysplasia (BPD),
one of the premature problems, is one of them. After a while, babies with heavy BPD are
discharged with the support of a home-type mechanical ventilator by opening a tracheostomy.
Tracheostomy procedure is performed by specialist doctors of otolaryngology under general
anesthesia in the operating room conditions in newborns. Complications of this procedure such
as bleeding, skin necrosis, decanulation, trachea laceration and infection in the early
period can be seen. In the long term, in addition to complications such as formation of
tracheal granulation tissue, ulceration, laceration due to the procedure, babies with
tracheostomy may develop nutrition and speech problems and neurodevelopmental problems.
In the literature, there is no comprehensive clinical follow-up study involving early and
late clinical results related to newborns undergoing tracheostomy. In this study, early and
late follow-up results (indications, anthropometric measurements, mechanical ventilation and
oxygen deposition times, complications, tracheostomy closure times, tracheostomy closure
times, neurodevelopmental patients in the Neonatal Intensive Care Unit of Hacettepe
University Ihsan Dogramaci Children's Hospital. results, accompanying other comorbidities,
etc.).
Detailed Description
With the advances in science and technology in recent years, the rate of survival of
high-risk newborns has increased in neonatal intensive care units. Some of these babies are
left in the neonatal intensive care unit for a long time, and because of the need for
respiratory support, tracheostomy is opened and discharged with home mechanical ventilator
devices.
Especially babies with severe BPD cannot be extubated and they may be exposed to trauma of
long-term intubation. Subglottic stenosis is the most common result of this trauma. Some of
the babies with severe BPD are discharged by the otolaryngology specialist doctor before
discharge, to prevent both long-term intubation complications, airway obstruction or tracheal
stenosis and adaptation to the home mechanical ventilator.
In addition to babies with BPD, tracheostomy is opened to babies in the early period due to
various developmental tracheal anomalies in our unit. Some of these are congenital tracheal
stenosis, congenital laryngeal atresia, laryngeal web.
In the following process, the growth of the baby, the development of the lungs and auxiliary
respiratory muscles and the need for mechanical ventilator support are eliminated and the
patient can wean from the ventilator support. In addition, the tracheostomy procedure secures
the patient's airway and allows it to be fed easily by mouth and the comfort of the patient.
When the tracheostomy requirement of the patient disappears (mechanical ventilator, when
oxygen is not needed), tracheostomy closure can be performed to ensure the patient has normal
larynx functions (sounding, speech, airway protection reflexes).
In the literature, there is no comprehensive clinical follow-up study involving early and
late clinical results related to newborns undergoing tracheostomy. In this study, early and
late follow-up results (indications, anthropometric measurements, mechanical ventilation and
oxygen deposition times, complications, tracheostomy closure times, tracheostomy closure
times, neurodevelopmental patients in the Neonatal Intensive Care Unit of Hacettepe
University Ihsan Dogramaci Children's Hospital results, accompanying other comorbidities,
etc.). This study is planned as a retrospective study. Participants planned to determine the
results of the study whether these babies should be careful in the follow-up and to take
precautions in order to lead a better and healthier life, and what participants can do in
order to provide these babies and their families with better health care support.
Study Type
Observational
Primary Outcome
follow up after tracheostomy
Secondary Outcome
evaluation of tracheostomy opening indications
Condition
Premature
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
80
Start Date
August 10, 2020
Completion Date
December 31, 2020
Primary Completion Date
December 31, 2020
Eligibility Criteria
Inclusion Criteria:
- These are the babies who stayed in Hacettepe University Ihsan Dogramaci Children's
Hospital Neonatal Intensive Care Unit between 01.01.2005-31.12.2019, underwent
tracheostomy procedure and followed up at risky neonatal outpatient clinic.
Exclusion Criteria:
- Newborns whose file and follow-up information required for the study are not available
Gender
All
Ages
N/A - 15 Years
Accepts Healthy Volunteers
No
Contacts
, +905305925584, [email protected]
Location Countries
Turkey
Location Countries
Turkey
Administrative Informations
NCT ID
NCT04497740
Organization ID
GO20529
Responsible Party
Principal Investigator
Study Sponsor
Hacettepe University
Study Sponsor
, ,
Verification Date
August 2020