Follow-up Results of Newborns With Tracheostomy

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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