Premature BirthNCT01294852
Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants
A study testing surfactant prophylaxis in people with Premature Birth and Premature Lungs, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine whether the immediate bolus strategy combined with early nasal CPAP (nCPAP) treatment could decrease the subsequent need for ventilation compared to the administration of surfactant prophylaxis at 15 minutes after birth with early nCPAP in premature infants. Read more about this study
- Who is it for?
- Ages 1 minute to 2 years
- Conditions the study is for
- Premature Birth, Premature Lungs
- What is being tested?
- surfactant prophylaxis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2010to Jun 2012
- 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 minute to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature infants born before 28 weeks' gestation
- Premature infants born at 29 to 30 weeks' gestation who did not receive antenatal steroid were randomized before delivery
Who cannot join
- Infants died at delivery room
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University Faculty of Medicine Department of Pediatrics
Ankara, 06620
Saadet Arsan, Professor, 90 312 5956390, Saadet.Arsan@medicine.ankara.edu.tr
Emel Okulu, MD, 90 312 5956390, emelderelli@hotmail.com
About this study
Official title: A Randomized Trial: Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants
The purpose of this study is to determine whether the immediate bolus strategy combined with early nasal CPAP (nCPAP) treatment could decrease the subsequent need for ventilation compared to the administration of surfactant prophylaxis at 15 minutes after birth with early nCPAP in premature infants.
Read the detailed description
Respiratory distress syndrome (RDS) is a syndrome in premature infants caused by developmental insufficiency of surfactant production and structural immaturity in the lungs. Exogenous surfactant therapy has become well established in newborn infants with RDS. Surfactant replacement therapy, either as a rescue treatment or a prophylactic, reduces mortality and several aspects of morbidity in babies with RDS. It is known that infants who are at a significant risk of RDS should receive prophylactic surfactant therapy, but the optimal timing and strategy for prophylactic surfactant therapy remains controversial. When administered immediately after delivery, surfactant mixes with the fetal lung fluid and reaches the alveoli before the onset of lung injury potentially created by the first applied positive pressure ventilation. As another approach, surfactant prophylaxis may be administered after resuscitation and stabilization.
- Conditions
- Premature Birth, Premature Lungs
- Being tested
- surfactant prophylaxis
- Keywords
- prophylactic, surfactant, premature, mechanical ventilation, mortality, morbidities
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surfactant prophylaxisOther
Premature infants born before 28 weeks' gestation and infants born at 29 to 30 weeks' gestation who did not receive antenatal steroid were randomized before delivery to receive either immediate bolus or post-resuscitation surfactant prophylaxis at 15 minutes after birth. Those infants who were randomized to immediate bolus surfactant were intubated as rapidly as possible after birth, were administered 100 mg/kg surfactant (Curosurf[Chiesi, Farmaceutici, Parma, Italy]), and received standard resuscitation measures as indicated. Those infants who were randomized to post-resuscitation surfactant received standard resuscitation measures first, were intubated electively at 15 minutes after birth and received 100 mg/kg surfactant (Curosurf[Chiesi, Farmaceutici, Parma, Italy]).
| Study group | Role | What they receive |
|---|---|---|
| immediate bolus surfactant | Experimental | Not described Receives: Other: surfactant prophylaxis |
| post-resuscitation surfactant | Experimental | Not described Receives: Other: surfactant prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilatory requirement
Infants with RDS may require mechanical ventilation. Mechinal ventilation causes volu- and barotrauma in the lungs and associated morbidities. The earlier surfactant is given, the better it works. So immediate surfactant prophylaxis given before the first breath may decrease the requirement for mechanical ventilation compared with surfactant prophylaxis given at 15 minutes of age after resuscitation and stabilization.
Measured: within the first 5 days of life
Secondary outcomes (9)
Pneumothorax
Measured: first 72 hours of life
Pulmonary hemorrhage
Measured: first 72 hours of life
patent ductus arteriosus
Measured: first one week
necrotizing enterocolitis
Measured: first one month
retinopathy of prematurity
Measured: first two months
intraventricular hemorrhage
Measured: first one week
bronchopulmonary dysplasia
Measured: first two months
duration of hospitalization
Measured: one year
mortality
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startJan 2010
- Primary completionJan 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Investigators
- Saadet Arsan, Professor, Study director, Ankara University Faculty of MedicineEmel Okulu, MD, Principal investigator, Ankara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294852
- Sponsor's protocol ID
- Ankara University-01
- Other IDs
- Ankara University
- Status last verified
- Dec 2009
- First submitted
- 11 Feb 2011
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial: Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants
- ClinicalTrials.gov ID
- NCT01294852
- Acronym / sponsor ID
- Ankara University-01
- Conditions
- Premature Birth, Premature Lungs
- Keywords
- prophylactic, surfactant, premature, mechanical ventilation, mortality, morbidities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 14 Feb 2011 (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 purpose of this study is to determine whether the immediate bolus strategy combined with early nasal CPAP (nCPAP) treatment could decrease the subsequent need for ventilation compared to the administration of surfactant prophylaxis at 15 minutes after birth with early nCPAP in premature infants.
Detailed description
Respiratory distress syndrome (RDS) is a syndrome in premature infants caused by developmental insufficiency of surfactant production and structural immaturity in the lungs. Exogenous surfactant therapy has become well established in newborn infants with RDS. Surfactant replacement therapy, either as a rescue treatment or a prophylactic, reduces mortality and several aspects of morbidity in babies with RDS. It is known that infants who are at a significant risk of RDS should receive prophylactic surfactant therapy, but the optimal timing and strategy for prophylactic surfactant therapy remains controversial. When administered immediately after delivery, surfactant mixes with the fetal lung fluid and reaches the alveoli before the onset of lung injury potentially created by the first applied positive pressure ventilation. As another approach, surfactant prophylaxis may be administered after resuscitation and stabilization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate bolus surfactant | Experimental | Other: surfactant prophylaxis |
| post-resuscitation surfactant | Experimental | Other: surfactant prophylaxis |
Who may qualify
- Ages
- 1 minute to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Premature infants born before 28 weeks' gestation
- Premature infants born at 29 to 30 weeks' gestation who did not receive antenatal steroid were randomized before delivery
Key exclusion criteria (1 listed)
- Infants died at delivery room
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 |
|---|---|---|
| surfactant prophylaxisPremature infants born before 28 weeks' gestation and infants born at 29 to 30 weeks' gestation who did not receive antenatal steroid were randomized before delivery to receive either immediate bolus or post-resuscitation surfactant prophylaxis at 15 minutes after birth. Those infants who were randomized to immediate bolus surfactant were intubated as rapidly as possible after birth, were administered 100 mg/kg surfactant (Curosurf[Chiesi, Farmaceutici, Parma, Italy]), and received standard resuscitation measures as indicated. Those infants who were randomized to post-resuscitation surfactant received standard resuscitation measures first, were intubated electively at 15 minutes after birth and received 100 mg/kg surfactant (Curosurf[Chiesi, Farmaceutici, Parma, Italy]). | Other | immediate bolus surfactant, post-resuscitation surfactant |
Primary outcome
ventilatory requirement
Time frame: within the first 5 days of life
Infants with RDS may require mechanical ventilation. Mechinal ventilation causes volu- and barotrauma in the lungs and associated morbidities. The earlier surfactant is given, the better it works. So immediate surfactant prophylaxis given before the first breath may decrease the requirement for mechanical ventilation compared with surfactant prophylaxis given at 15 minutes of age after resuscitation and stabilization.
9 secondary outcomes
Pneumothorax
Time frame: first 72 hours of life
Pulmonary hemorrhage
Time frame: first 72 hours of life
patent ductus arteriosus
Time frame: first one week
necrotizing enterocolitis
Time frame: first one month
retinopathy of prematurity
Time frame: first two months
intraventricular hemorrhage
Time frame: first one week
bronchopulmonary dysplasia
Time frame: first two months
duration of hospitalization
Time frame: one year
mortality
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
Related trials for Premature Birth
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nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
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Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Saadet Arsan, Professor study director
Ankara University Faculty of Medicine
Emel Okulu, MD principal investigator
Ankara University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surfactant prophylaxis in people with Premature Birth and Premature Lungs, run by Ankara 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 2 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 22 Jun 2011. 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 Saadet Arsan, Professor (90 312 5956390, Saadet.Arsan@medicine.ankara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventilatory requirement (time frame: within the first 5 days of life). 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 22 Jun 2011.