Pulmonary HemorrhageNCT01860014
Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage
A study testing Poractant alfa and Beractant in people with Pulmonary Hemorrhage, run by Dr. Sami Ulus Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
The incidence of pulmonary hemorrhage (PH) was about 1.3 per 1,000 live births. PH occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. Read more about this study
- Who is it for?
- Ages 1 hour to 1 week
- Conditions the study is for
- Pulmonary Hemorrhage
- What is being tested?
- Poractant alfa and Beractant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2010to Mar 2011
- 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 1 hour to 1 week
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature infants <1500 g
- Within first week of life
Who cannot join
- Major congenital abnormalities
- Without parental consent
Trial locations and contacts
1 site in 1 country.
About this study
The incidence of pulmonary hemorrhage (PH) was about 1.3 per 1,000 live births. PH occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. Although not clear, the cause of PH is thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow. Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising results in treating PH.In this study we aimed to evaluate the effect of two different natural surfactants in neonates with pulmonary hemorrhage.
Read the detailed description
The incidence of PH was about 1.3 per 1,000 live births. Formerly,the risk factors associated with PH included the severity of the associated illness, intrauterine growth restriction, patent ductus arteriosus (PDA), coagulopathy, and the need for assisted ventilation. Currently, PH occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. Currently, PH complicates the hospital course of 3-5% of preterm infants with RDS. The cause of PH is thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow. Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising results in treating PH.In this study we aimed to evaluate the effect of two different natural surfactants in neonates with pulmonary hemorrhage.
- Conditions
- Pulmonary Hemorrhage
- Being tested
- Poractant alfa, Beractant
- Keywords
- Pulmonary hemorrhage, Mortality, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poractant alfaDrug
Also called Curosurf
Curosurf: 100 mg/kg-intratracheal, just after pulmonary hemorrhage
BeractantDrug
Also called Survanta
Survanta: 100 mg/kg-intratracheal, just after pulmonary hemorrhage
| Study group | Role | What they receive |
|---|---|---|
| Beractant | Active comparator | Beractant (Survanta): 100 mg/kg-intratracheal, just after pulmonary hemorrhage Receives: Drug: Poractant alfa |
| Poractant alfa | Active comparator | Poractant alfa (Curosurf): 100 mg/kg-intratracheal, just after pulmonary hemorrhage Receives: Drug: Beractant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen requirement
We will evaluate the need of oxygen support within 6 hour after surfactant
Measured: 6 hour
Secondary outcomes (1)
Mortality
We will compare the rate of mortality between the groups during neonatal period
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startMar 2010
- Primary completionJan 2011
- Study completionMar 2011
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 Pulmonary HemorrhageStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Sami Ulus Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Dilli, Dr. Sami Ulus Children's Hospital
- Investigators
- Şenol Bozdağ, MD, Principal investigator, Zekai Tahir Burak Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860014
- Sponsor's protocol ID
- 306/29 March 2010
- Other IDs
- 306/29 March 2010
- Status last verified
- May 2013
- First submitted
- 20 May 2013
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rogers D. Pulmonary haemorrhage, surfactant, and low-birthweight babies. Lancet. 1993 Mar 13;341(8846):698. doi: 10.1016/0140-6736(93)90469-w. No abstract available.
PubMed 8095608
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage
- ClinicalTrials.gov ID
- NCT01860014
- Acronym / sponsor ID
- 306/29 March 2010
- Conditions
- Pulmonary Hemorrhage
- Keywords
- Pulmonary hemorrhage, Mortality, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dr. Sami Ulus Children's HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 May 2013 (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.
The incidence of pulmonary hemorrhage (PH) was about 1.3 per 1,000 live births. PH occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. Although not clear, the cause of PH is thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow. Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising results in treating PH.In this study we aimed to evaluate the effect of two different natural surfactants in neonates with pulmonary hemorrhage.
Detailed description
The incidence of PH was about 1.3 per 1,000 live births. Formerly,the risk factors associated with PH included the severity of the associated illness, intrauterine growth restriction, patent ductus arteriosus (PDA), coagulopathy, and the need for assisted ventilation. Currently, PH occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. Currently, PH complicates the hospital course of 3-5% of preterm infants with RDS. The cause of PH is thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow. Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising results in treating PH.In this study we aimed to evaluate the effect of two different natural surfactants in neonates with pulmonary hemorrhage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beractant | Active comparator | Drug: Poractant alfaBeractant (Survanta): 100 mg/kg-intratracheal, just after pulmonary hemorrhage |
| Poractant alfa | Active comparator | Drug: BeractantPoractant alfa (Curosurf): 100 mg/kg-intratracheal, just after pulmonary hemorrhage |
Who may qualify
- Ages
- 1 hour to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Premature infants <1500 g
- Within first week of life
Key exclusion criteria (2 listed)
- Major congenital abnormalities
- Without parental consent
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 |
|---|---|---|
| Poractant alfaAlso: CurosurfCurosurf: 100 mg/kg-intratracheal, just after pulmonary hemorrhage | Drug | Beractant |
| BeractantAlso: SurvantaSurvanta: 100 mg/kg-intratracheal, just after pulmonary hemorrhage | Drug | Poractant alfa |
Primary outcome
Oxygen requirement
Time frame: 6 hour
We will evaluate the need of oxygen support within 6 hour after surfactant
1 secondary outcome
Mortality
Time frame: 4 weeks
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 22 May 2013.
- Results publication: PubMed 8095608Rogers D. Pulmonary haemorrhage, surfactant, and low-birthweight babies. Lancet. 1993 Mar 13;341(8846):698. doi: 10.1016/0140-6736(93)90469-w. No abstract available.
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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.
Şenol Bozdağ, MD principal investigator
Zekai Tahir Burak 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 Poractant alfa and Beractant in people with Pulmonary Hemorrhage, run by Dr. Sami Ulus Children's 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 2 inclusion and 2 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 22 May 2013. 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?
Oxygen requirement (time frame: 6 hour). 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 NCT01860014, 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 22 May 2013.