Respiratory Distress Syndrome, NewbornNCT03165305
The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants
A study testing Sustained Inflation in people with Respiratory Distress Syndrome, Newborn and Transient Tachypnea of the Newborn, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Sustained inflation (SI) has been reported to be effective for reducing the need for intubation and/or invasive ventilation in preterm infants. However, it has also an important role to support the initial breaths and liquid removal from the airways. Read more about this study
- Who is it for?
- Ages Up to 2 minutesHealthy volunteers can take part
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Transient Tachypnea of the Newborn, Respiratory Morbidity
- What is being tested?
- Sustained Inflation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 1 Jun 2019
- Phase
- Interventional
- 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 2 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- term newborns
- parental informed consent
- inborn infants
Who cannot join
- major congenital/chromosomal abnormalities
- lack of informed consent
- outborn infants
- Premature infants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul
About this study
Sustained inflation (SI) has been reported to be effective for reducing the need for intubation and/or invasive ventilation in preterm infants. However, it has also an important role to support the initial breaths and liquid removal from the airways. Therefore, the investigators hypothesized that SI performed just after birth may help to facilitate the transitional period and decrease the incidence of early respiratory morbidities such as transient tachypnea in term infants.
- Conditions
- Respiratory Distress Syndrome, Newborn, Transient Tachypnea of the Newborn, Respiratory Morbidity
- Being tested
- Sustained Inflation
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Transient Tachypnea of the Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained InflationOther
Administering a pressure of 30 cm H20 by a T-piece resuscitator for 5 seconds immediately after birth.
| Study group | Role | What they receive |
|---|---|---|
| Sustained Inflation Group | Experimental | Includes the infants who administered sustained inflation for 5 seconds with a pressure of 30cm H20 immediately after the delivery. Receives: Other: Sustained Inflation |
| No Intervention group | No intervention | Includes routine neonatal care in the delivery room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Morbidity
RDS, TTN, requirement for supplemental oxygen, intubation or mechanical ventilation support
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Apr 2018
- Primary completion5 May 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merih Cetinkaya, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Merih Cetinkaya, Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165305
- Sponsor's protocol ID
- 123
- Status last verified
- Aug 2019
- First submitted
- 23 May 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants
- ClinicalTrials.gov ID
- NCT03165305
- Acronym / sponsor ID
- 123
- Conditions
- Respiratory Distress Syndrome, Newborn, Transient Tachypnea of the Newborn, Respiratory Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sustained inflation (SI) has been reported to be effective for reducing the need for intubation and/or invasive ventilation in preterm infants. However, it has also an important role to support the initial breaths and liquid removal from the airways. Therefore, the investigators hypothesized that SI performed just after birth may help to facilitate the transitional period and decrease the incidence of early respiratory morbidities such as transient tachypnea in term infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sustained Inflation Group | Experimental | Other: Sustained InflationIncludes the infants who administered sustained inflation for 5 seconds with a pressure of 30cm H20 immediately after the delivery. |
| No Intervention group | No intervention | –Includes routine neonatal care in the delivery room |
Who may qualify
- Ages
- Up to 2 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- term newborns
- parental informed consent
- inborn infants
Key exclusion criteria (4 listed)
- major congenital/chromosomal abnormalities
- lack of informed consent
- outborn infants
- Premature infants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustained InflationAdministering a pressure of 30 cm H20 by a T-piece resuscitator for 5 seconds immediately after birth. | Other | Sustained Inflation Group |
Primary outcome
Respiratory Morbidity
Time frame: 2 hours
RDS, TTN, requirement for supplemental oxygen, intubation or mechanical ventilation support
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merih Cetinkaya principal investigator
Kanuni Sultan Suleyman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sustained Inflation in people with Respiratory Distress Syndrome, Newborn and Transient Tachypnea of the Newborn, run by Kanuni Sultan Suleyman Training and Research Hospital 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 13 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Morbidity (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2019.