Meconium Aspiration SyndromePhase 4NCT02041546
Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome
A Phase 4 study testing Lung lavage with surfactant and Bolus surfactant in people with Meconium Aspiration Syndrome, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Meconium aspiration syndrome (MAS) is an important cause of severe respiratory failure in newborn infants. Treatment for MAS is mainly supportive but surfactant therapy might change the course of the disease. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Meconium Aspiration Syndrome
- What is being tested?
- Lung lavage with surfactant and Bolus surfactant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2013to Dec 2014
- Phase
- Phase 4
- 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 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with a gestational age ≥ 36 weeks, birth weight ≥ 2.0 kg, evidence of passage of meconium at or before delivery, typical chest radiology findings and mechanically ventilated infants with a mean airway pressure ≥ 12 cm H2O were enrolled.
Who cannot join
- Congenital cardiac anomalies
- Major congenital anomalies
- Hemodynamically unstable infants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, 06230
About this study
Official title: Zekai Tahir Burak Maternity Teaching Hospital
Meconium aspiration syndrome (MAS) is an important cause of severe respiratory failure in newborn infants. Treatment for MAS is mainly supportive but surfactant therapy might change the course of the disease. Aim of the study to evaluate whether lung lavage with dilute or bolus poractant alfa changes the duration of mechanical respiratory support or other outcomes in MAS.
- Conditions
- Meconium Aspiration Syndrome
- Being tested
- Lung lavage with surfactant, Bolus surfactant
- Keywords
- Lung lavage,, Surfactant,, Duration of mechanical, ventilation
- Medical subject headings
- Meconium Aspiration Syndrome, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung lavage with surfactantDrug
Also called Poractant alfa
Bolus surfactantDrug
Also called Poractant alfa
| Study group | Role | What they receive |
|---|---|---|
| Bolus surfactant | Active comparator | Bolus surfactant 100 mg/kg proctant alfa Receives: Drug: Bolus surfactant |
| Lung lavage with surfactant | Active comparator | Lung lavage with surfactant Receives: Drug: Lung lavage with surfactant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation
Total duration of mechanical ventilation, mode and ventilator parameters are noted till the baby is on mechanical ventilation.
Measured: up to 2 weeks
Secondary outcomes (3)
Complications
Incidence of Persistent Pulmonary Hypertension by Echocardiography and Pneumothorax by transillumination confirmed by chest x-ray.
Measured: up to 4 weeks
Duration of Hospital Stay
We will record length of stay in a level III neonatal intensive care unit.
Measured: Up to 8 weeks or till discharge
Mortality
We will record who died until discharge.
Measured: Up to 3 months or till discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meconium Aspiration SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041546
- Sponsor's protocol ID
- ZTB0607
- Status last verified
- Aug 2016
- First submitted
- 15 Jan 2014
- Last updated
- 3 Aug 2016
- Results posted
- No
Publications
Arayici S, Sari FN, Kadioglu Simsek G, Yarci E, Alyamac Dizdar E, Uras N, Canpolat FE, Oguz SS. Lung Lavage with Dilute Surfactant vs. Bolus Surfactant for Meconium Aspiration Syndrome. J Trop Pediatr. 2019 Oct 1;65(5):491-497. doi: 10.1093/tropej/fmy081.
PubMed 30690595
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zekai Tahir Burak Maternity Teaching Hospital
- ClinicalTrials.gov ID
- NCT02041546
- Acronym / sponsor ID
- ZTB0607
- Conditions
- Meconium Aspiration Syndrome
- Keywords
- Lung lavage,, Surfactant,, Duration of mechanical, ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Jan 2014 (estimated)
- 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.
Meconium aspiration syndrome (MAS) is an important cause of severe respiratory failure in newborn infants. Treatment for MAS is mainly supportive but surfactant therapy might change the course of the disease. Aim of the study to evaluate whether lung lavage with dilute or bolus poractant alfa changes the duration of mechanical respiratory support or other outcomes in MAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bolus surfactant | Active comparator | Drug: Bolus surfactantBolus surfactant 100 mg/kg proctant alfa |
| Lung lavage with surfactant | Active comparator | Drug: Lung lavage with surfactantLung lavage with surfactant |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants with a gestational age ≥ 36 weeks, birth weight ≥ 2.0 kg, evidence of passage of meconium at or before delivery, typical chest radiology findings and mechanically ventilated infants with a mean airway pressure ≥ 12 cm H2O were enrolled.
Key exclusion criteria (3 listed)
- Congenital cardiac anomalies
- Major congenital anomalies
- Hemodynamically unstable 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 |
|---|---|---|
| Lung lavage with surfactantAlso: Poractant alfa | Drug | Lung lavage with surfactant |
| Bolus surfactantAlso: Poractant alfa | Drug | Bolus surfactant |
Primary outcome
Duration of mechanical ventilation
Time frame: up to 2 weeks
Total duration of mechanical ventilation, mode and ventilator parameters are noted till the baby is on mechanical ventilation.
3 secondary outcomes
Complications
Time frame: up to 4 weeks
Duration of Hospital Stay
Time frame: Up to 8 weeks or till discharge
Mortality
Time frame: Up to 3 months or till discharge
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 3 Aug 2016.
- Derived from this study: PubMed 30690595Arayici S, Sari FN, Kadioglu Simsek G, Yarci E, Alyamac Dizdar E, Uras N, Canpolat FE, Oguz SS. Lung Lavage with Dilute Surfactant vs. Bolus Surfactant for Meconium Aspiration Syndrome. J Trop Pediatr. 2019 Oct 1;65(5):491-497. doi: 10.1093/tropej/fmy081.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lung lavage with surfactant and Bolus surfactant in people with Meconium Aspiration Syndrome, run by Zekai Tahir Burak Women's Health Research and Education 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 1 inclusion and 3 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 3 Aug 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Duration of mechanical ventilation (time frame: up to 2 weeks). 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 NCT02041546, 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 3 Aug 2016.