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PrematureFRONWTNCT04497740

Follow-up Results of Newborns With Tracheostomy

An observational study of Premature and Tracheostomy Complication, run by Hacettepe University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 15 years
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Aug 2020to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • Newborns whose file and follow-up information required for the study are not available

Trial locations and contacts

1 site in 1 country.

Hasan T Celik, Ass Prof. contact

+905305925584

htcelik@gmail.com

Turkey (Türkiye)1 site
  • Hacettepe University

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Retrospective Evaluation of Follow-up Results of Newborns Who Underwent Tracheostomy

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.).

Read the 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.

Medical subject headings
Premature Birth, Bronchopulmonary Dysplasia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. follow up after tracheostomy

    Follow-up of patients who have been in our NICU for the last fifteen years and discharged with tracheostomy.

    Measured: 15 years

Secondary outcomes (1)
  1. evaluation of tracheostomy opening indications

    indications of tracheostomy in the last fifteen years in our unit

    Measured: 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2020
  2. Study start10 Aug 2020 (estimated)
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04497740
Sponsor's protocol ID
GO20529
Acronym
FRONWT
Status last verified
Aug 2020
First submitted
30 Jul 2020
Last updated
6 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tandircioglu UA, Dogan O, Gunaydin RO, Yigit S, Celik HT. Outcomes of newborns with tracheostomy: single center experience. Turk J Pediatr. 2023;65(4):555-561. doi: 10.24953/turkjped.2023.185.

    PubMed 37661670

Questions about this trial

What is this clinical trial studying?

An observational study of Premature and Tracheostomy Complication, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hasan T Celik, Ass Prof. (+905305925584, htcelik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

follow up after tracheostomy (time frame: 15 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04497740, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.

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