Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants
Primary Purpose
Premature Birth, Premature Lungs
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
surfactant prophylaxis
Sponsored by
About this trial
This is an interventional prevention trial for Premature Birth focused on measuring prophylactic, surfactant, premature, mechanical ventilation, mortality, morbidities
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Infants died at delivery room
Sites / Locations
- Ankara University Faculty of Medicine Department of PediatricsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
immediate bolus surfactant
post-resuscitation surfactant
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pneumothorax
Pulmonary hemorrhage
patent ductus arteriosus
necrotizing enterocolitis
retinopathy of prematurity
intraventricular hemorrhage
bronchopulmonary dysplasia
duration of hospitalization
mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01294852
Brief Title
Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants
Official Title
A Randomized Trial: Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Ankara University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, Premature Lungs
Keywords
prophylactic, surfactant, premature, mechanical ventilation, mortality, morbidities
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
immediate bolus surfactant
Arm Type
Experimental
Arm Title
post-resuscitation surfactant
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
surfactant prophylaxis
Intervention Description
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]).
Primary Outcome Measure Information:
Title
ventilatory requirement
Description
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.
Time Frame
within the first 5 days of life
Secondary Outcome Measure Information:
Title
Pneumothorax
Time Frame
first 72 hours of life
Title
Pulmonary hemorrhage
Time Frame
first 72 hours of life
Title
patent ductus arteriosus
Time Frame
first one week
Title
necrotizing enterocolitis
Time Frame
first one month
Title
retinopathy of prematurity
Time Frame
first two months
Title
intraventricular hemorrhage
Time Frame
first one week
Title
bronchopulmonary dysplasia
Time Frame
first two months
Title
duration of hospitalization
Time Frame
one year
Title
mortality
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Infants died at delivery room
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saadet Arsan, Professor
Phone
90 312 5956390
Email
Saadet.Arsan@medicine.ankara.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Emel Okulu, MD
Phone
90 312 5956390
Email
emelderelli@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saadet Arsan, Professor
Organizational Affiliation
Ankara University Faculty of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Emel Okulu, MD
Organizational Affiliation
Ankara University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara University Faculty of Medicine Department of Pediatrics
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saadet Arsan, Professor
Phone
90 312 5956390
Email
Saadet.Arsan@medicine.ankara.edu.tr
First Name & Middle Initial & Last Name & Degree
Emel Okulu, MD
Phone
90 312 5956390
Email
emelderelli@hotmail.com
First Name & Middle Initial & Last Name & Degree
Emel Okulu, MD
12. IPD Sharing Statement
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Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants
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