Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Ankara University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Ankara University
Information provided by:
Ankara University
ClinicalTrials.gov Identifier:
NCT01294852
First received: February 11, 2011
Last updated: June 21, 2011
Last verified: December 2009
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 11, 2011 | ||||||||
| Last Updated Date | June 21, 2011 | ||||||||
| Start Date ICMJE | January 2010 | ||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
ventilatory requirement [ Time Frame: within the first 5 days of life ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01294852 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants | ||||||||
| Official Title ICMJE | A Randomized Trial: Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants | ||||||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Other: surfactant prophylaxis
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]). |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | June 2012 | ||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 2 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Turkey | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01294852 | ||||||||
| Other Study ID Numbers ICMJE | Ankara University-01, Ankara University | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Ankara University Faculty of Medicine, Ankara University | ||||||||
| Study Sponsor ICMJE | Ankara University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Ankara University | ||||||||
| Verification Date | December 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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