David K. Stevenson, M.D.
Continuous Positive Airway Pressure (CPAP) Versus Surfactant, and a Lower Versus a Higher Oxygen Saturation in 24 to 27 Week Preterm Infants
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This study will compare the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, will have a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study will determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Procedure: Continuous positive airway pressure versus early surfactant
- Procedure: Higher versus lower range of oxygen saturation
Phase:
Phase 3Eligibility
Ages Eligible for Study:
24 weeks to 27 weeksGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Infants with a minimal gestational age of 24 weeks 0 days to 27 completed weeks (up to 27 6/7ths) by best obstetrical estimate
- Infants who will receive full resuscitation as necessary, i.e., no parental request or physician decision to forego resuscitation
- Infants whose parents/legal guardians have provided consent for enrollment, or
- Infants without known major congenital malformations
Key Exclusion Criteria:
- Any infant transported to the center after delivery
- Infants whose parents/legal guardians refuse consent
- Infants born during a time when the research apparatus/study personnel are not available
- Infants < 24 weeks 0 days or > 28 weeks 0 days, completed weeks of gestation
Additional Study Details
Official Title:
The Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants. The SUPPORT Trial. A Protocol for the NICHD Neonatal Research Network.Anticipated start date:
3/31/2005Lead Sponsor:
National Institute of Child Health and Human Development (NICollaborator(s):
- National Heart, Lung, and Blood Institute (NHLBI)
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Single BlindControl:
noneAssignment:
FactorialEndpoints:
EfficacyPrimary Outcomes:
- survival without bronchopulmonary dysplasia (BPD) at 36 weeks
- survival without the occurrence of threshold retinopathy of prematurity (ROP) and/or the need for surgical intervention
- mortality/neurodevelopmental outcome at 18-22 months corrected age
Secondary Outcomes:
- endotracheal intubation before 10 minutes of age
- duration of mechanical ventilation
- surfactant treatment
- air leaks
- intubation
- duration of mechanical ventilation
- duration of oxygen supplementation
- oximetry values > 90%
- blindness of at least one eye at 18-22 months
- use of postnatal steroids
- the physiologic definition of BPD
- necrotizing enterocolitis (NEC)
- intraventricular hemorrhage (IVH) and severe IVH
- periventricular leukomalacia
- cerebral palsy
Total Number to be Enrolled:
1310Total Number to be Enrolled at Stanford:
56More Information
Publications About this Study:
- 15342835: Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK; National Institute of Child Health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics. 2004 Sep;114(3):651-7.
Secondary ID(s):
- U10 HD27880
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
3/9/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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