Surfactant Positive Airway Pressure and Pulse Oximetry Trial
NCT ID: NCT00233324
Last Updated: 2019-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1316 participants
INTERVENTIONAL
2005-02-28
2016-08-31
Brief Summary
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Detailed Description
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Strata: There were two randomization strata, infants of 24 0/7ths to 25 6/7ths weeks, and infants of 26 0/7ths-27 6/7ths weeks by best obstetrical estimate.
Randomization:
Randomization was stratified by gestational age group, occurred prior to delivery for consented deliveries, and was performed by utilizing specially prepared double-sealed envelopes. Deliveries were randomized as a unit, thus multiples, twins, triplets, etc. were randomized to the same arm of the trial.
Informed Consent:
Parents were approached prior to delivery for informed consent, and their infants enrolled at delivery.
Study Intervention: Mode of Ventilatory Support The intervention began after birth when the infant was given to the resuscitation team. The conduct of the resuscitation followed usual guidelines, and once stabilized, all Control infants in both strata received prophylactic/early surfactant (within one hour of age), whereas all Treatment infants were placed on CPAP/PEEP following stabilization, and were intubated only for resuscitation indications.
Pulse Oximeter Allocation:
Infants were randomized to receive either a high- or low-saturation of peripheral oxygen (SpO2) as monitored by a study oximeter immediately following NICU admission, with a maximum allowable delay of two hours following admission.
The SUPPORT Trial recruitment was temporarily paused on November 23, 2005 based on concern regarding pulse oximeter readings \> 95% and due to concern regarding separation of the two arms of the oximetry portion of the study. Further analyses were performed which showed that infants on room air accounted for a significant portion of pulse oximetry saturations above 95%. Separation of the two groups was reanalyzed based on time spent in room air and the duration of time spent at individual SpO2 values, which both showed group differences. The trial was restarted on February 6, 2006.
Follow-up: Subjects will be seen for a follow-up visit at 18-22 months corrected age to look at neurodevelopment.
Extended follow-up: Subjects enrolled in the Neuroimaging/MRI secondary study will also be seen for a follow-up visit at 6-7 years to look at later school-age development. Subjects attending the 6-7 year follow-up visit will be invited to participate in this secondary study which will analyze the relationship of salivary cortisol and dehydroepiandrosterone (DHEA) to: (a) blood pressure and adiposity; (b) prenatal and postnatal growth; and (c) DNA methylation patterns.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Surfactant and Low Oxygen
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Surfactant
Intubation and administration of surfactant by 1 hour of age.
Supplemental oxygen with target saturation of 85 to 89%
Supplemental oxygen in the range of 85% to 89% until the infant is no longer requiring ventilatory support or oxygen
Surfactant and High Oxygen
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturationof 91% to 95%
Surfactant
Intubation and administration of surfactant by 1 hour of age.
Supplemental oxygen with target saturation of 91 to 95%
Supplemental oxygen in the range of 91% to 95% until the infant is no longer requiring ventilatory support or oxygen.
CPAP and Low Oxygen
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Continuous Positive Airway Pressure (CPAP)
Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
Supplemental oxygen with target saturation of 85 to 89%
Supplemental oxygen in the range of 85% to 89% until the infant is no longer requiring ventilatory support or oxygen
CPAP and High Oxygen
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Continuous Positive Airway Pressure (CPAP)
Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
Supplemental oxygen with target saturation of 91 to 95%
Supplemental oxygen in the range of 91% to 95% until the infant is no longer requiring ventilatory support or oxygen.
Interventions
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Surfactant
Intubation and administration of surfactant by 1 hour of age.
Continuous Positive Airway Pressure (CPAP)
Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
Supplemental oxygen with target saturation of 85 to 89%
Supplemental oxygen in the range of 85% to 89% until the infant is no longer requiring ventilatory support or oxygen
Supplemental oxygen with target saturation of 91 to 95%
Supplemental oxygen in the range of 91% to 95% until the infant is no longer requiring ventilatory support or oxygen.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
24 Weeks
27 Weeks
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Center for Research Resources (NCRR)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
NICHD Neonatal Research Network
NETWORK
Responsible Party
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Principal Investigators
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Abbot R. Laptook, MD
Role: PRINCIPAL_INVESTIGATOR
Brown University, Women & Infants Hospital of Rhode Island
Michele C. Walsh, MD MS
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University, Rainbow Babies and Children's Hospital
Ronald N. Goldberg, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Barbara J. Stoll, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Brenda B. Poindexter, MD MS
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Abhik Das, PhD
Role: PRINCIPAL_INVESTIGATOR
RTI International
Krisa P. Van Meurs, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Ivan D. Frantz III, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Neil N. Finer, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Kurt Schibler, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Waldemar A. Carlo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Edward F. Bell, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Kristi L. Watterberg, MD
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico
Pablo J. Sanchez, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas, Southwestern Medical Center at Dallas
Kathleen A. Kennedy, MD MPH
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Roger G. Faix, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Seetha Shankaran, MD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Richard A. Ehrenkranz, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
University of California at San Diego
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Tufts Medical Center
Boston, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
University of New Mexico
Albuquerque, New Mexico, United States
University of Rochester
Rochester, New York, United States
Wake Forest University
Charlotte, North Carolina, United States
RTI International
Durham, North Carolina, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
University of Tennessee
Memphis, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Deuticke B. Monocarboxylate transport in red blood cells: kinetics and chemical modification. Methods Enzymol. 1989;173:300-29. doi: 10.1016/s0076-6879(89)73020-2. No abstract available.
SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Carlo WA, Finer NN, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Schibler K, Newman NS, Ambalavanan N, Frantz ID 3rd, Piazza AJ, Sanchez PJ, Morris BH, Laroia N, Phelps DL, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Ehrenkranz RA, Watterberg KL, Higgins RD. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1959-69. doi: 10.1056/NEJMoa0911781. Epub 2010 May 16.
SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Finer NN, Carlo WA, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Donovan EF, Newman NS, Ambalavanan N, Frantz ID 3rd, Buchter S, Sanchez PJ, Kennedy KA, Laroia N, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Bhandari V, Watterberg KL, Higgins RD. Early CPAP versus surfactant in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1970-9. doi: 10.1056/NEJMoa0911783. Epub 2010 May 16.
Rich WD, Auten KJ, Gantz MG, Hale EC, Hensman AM, Newman NS, Finer NN; National Institute of Child Health and Human Development Neonatal Research Network. Antenatal consent in the SUPPORT trial: challenges, costs, and representative enrollment. Pediatrics. 2010 Jul;126(1):e215-21. doi: 10.1542/peds.2009-3353. Epub 2010 Jun 29.
Di Fiore JM, Walsh M, Wrage L, Rich W, Finer N, Carlo WA, Martin RJ; SUPPORT Study Group of Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Low oxygen saturation target range is associated with increased incidence of intermittent hypoxemia. J Pediatr. 2012 Dec;161(6):1047-52. doi: 10.1016/j.jpeds.2012.05.046. Epub 2012 Jun 26.
Rich W, Finer NN, Gantz MG, Newman NS, Hensman AM, Hale EC, Auten KJ, Schibler K, Faix RG, Laptook AR, Yoder BA, Das A, Shankaran S; SUPPORT and Generic Database Subcommittees of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Enrollment of extremely low birth weight infants in a clinical research study may not be representative. Pediatrics. 2012 Mar;129(3):480-4. doi: 10.1542/peds.2011-2121. Epub 2012 Feb 27.
Ambalavanan N, Carlo WA, Wrage LA, Das A, Laughon M, Cotten CM, Kennedy KA, Laptook AR, Shankaran S, Walsh MC, Higgins RD; SUPPORT Study Group of the NICHD Neonatal Research Network. PaCO2 in surfactant, positive pressure, and oxygenation randomised trial (SUPPORT). Arch Dis Child Fetal Neonatal Ed. 2015 Mar;100(2):F145-9. doi: 10.1136/archdischild-2014-306802. Epub 2014 Nov 25.
Navarrete CT, Wrage LA, Carlo WA, Walsh MC, Rich W, Gantz MG, Das A, Schibler K, Newman NS, Piazza AJ, Poindexter BB, Shankaran S, Sanchez PJ, Morris BH, Frantz ID 3rd, Van Meurs KP, Cotten CM, Ehrenkranz RA, Bell EF, Watterberg KL, Higgins RD, Duara S; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Growth Outcomes of Preterm Infants Exposed to Different Oxygen Saturation Target Ranges from Birth. J Pediatr. 2016 Sep;176:62-68.e4. doi: 10.1016/j.jpeds.2016.05.070. Epub 2016 Jun 22.
Stevens TP, Finer NN, Carlo WA, Szilagyi PG, Phelps DL, Walsh MC, Gantz MG, Laptook AR, Yoder BA, Faix RG, Newman JE, Das A, Do BT, Schibler K, Rich W, Newman NS, Ehrenkranz RA, Peralta-Carcelen M, Vohr BR, Wilson-Costello DE, Yolton K, Heyne RJ, Evans PW, Vaucher YE, Adams-Chapman I, McGowan EC, Bodnar A, Pappas A, Hintz SR, Acarregui MJ, Fuller J, Goldstein RF, Bauer CR, O'Shea TM, Myers GJ, Higgins RD; SUPPORT Study Group of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Respiratory outcomes of the surfactant positive pressure and oximetry randomized trial (SUPPORT). J Pediatr. 2014 Aug;165(2):240-249.e4. doi: 10.1016/j.jpeds.2014.02.054. Epub 2014 Apr 13.
Vaucher YE, Peralta-Carcelen M, Finer NN, Carlo WA, Gantz MG, Walsh MC, Laptook AR, Yoder BA, Faix RG, Das A, Schibler K, Rich W, Newman NS, Vohr BR, Yolton K, Heyne RJ, Wilson-Costello DE, Evans PW, Goldstein RF, Acarregui MJ, Adams-Chapman I, Pappas A, Hintz SR, Poindexter B, Dusick AM, McGowan EC, Ehrenkranz RA, Bodnar A, Bauer CR, Fuller J, O'Shea TM, Myers GJ, Higgins RD; SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network. Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial. N Engl J Med. 2012 Dec 27;367(26):2495-504. doi: 10.1056/NEJMoa1208506.
Lowe J, Bann CM, Dempsey AG, Fuller J, Taylor HG, Gustafson KE, Watson VE, Vohr BR, Das A, Shankaran S, Yolton K, Ball MB, Hintz SR; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Do Bayley-III Composite Scores at 18-22 Months Corrected Age Predict Full-Scale IQ at 6-7 Years in Children Born Extremely Preterm? J Pediatr. 2023 Dec;263:113700. doi: 10.1016/j.jpeds.2023.113700. Epub 2023 Aug 26.
Lowe J, Fuller JF, Dempsey AG, Do B, Bann CM, Das A, Gustafson KE, Vohr BR, Hintz SR, Watterberg KL; SUPPORT NEURO School-Age Study Subcommittee of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Cortisol awakening response and developmental outcomes at 6-7 years in children born extremely preterm. Pediatr Res. 2023 Feb;93(3):689-695. doi: 10.1038/s41390-022-02113-9. Epub 2022 Jun 17.
Duncan AF, Bann CM, Dempsey AG, Adams-Chapman I, Heyne R, Hintz SR; Eunice Kennedy Shriver National Institute of Child Health and Development Neonatal Research Network. Neuroimaging and Bayley-III correlates of early hand function in extremely preterm children. J Perinatol. 2019 Mar;39(3):488-496. doi: 10.1038/s41372-019-0314-0. Epub 2019 Jan 28.
Duncan AF, Bann CM, Dempsey A, Peralta-Carcelen M, Hintz S; Eunice Kennedy Shriver National Institute of Child Health and Development Neonatal Research Network. Behavioral Deficits at 18-22 Months of Age Are Associated with Early Cerebellar Injury and Cognitive and Language Performance in Children Born Extremely Preterm. J Pediatr. 2019 Jan;204:148-156.e4. doi: 10.1016/j.jpeds.2018.08.059. Epub 2018 Oct 3.
Chawla S, Natarajan G, Shankaran S, Carper B, Brion LP, Keszler M, Carlo WA, Ambalavanan N, Gantz MG, Das A, Finer N, Goldberg RN, Cotten CM, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Markers of Successful Extubation in Extremely Preterm Infants, and Morbidity After Failed Extubation. J Pediatr. 2017 Oct;189:113-119.e2. doi: 10.1016/j.jpeds.2017.04.050. Epub 2017 Jun 7.
Di Fiore JM, Martin RJ, Li H, Morris N, Carlo WA, Finer N, Walsh M; SUPPORT Study Group of the Eunice Kennedy Shriver National Institute of Child Health, and Human Development Neonatal Research Network. Patterns of Oxygenation, Mortality, and Growth Status in the Surfactant Positive Pressure and Oxygen Trial Cohort. J Pediatr. 2017 Jul;186:49-56.e1. doi: 10.1016/j.jpeds.2017.01.057. Epub 2017 Mar 6.
Hintz SR, Barnes PD, Bulas D, Slovis TL, Finer NN, Wrage LA, Das A, Tyson JE, Stevenson DK, Carlo WA, Walsh MC, Laptook AR, Yoder BA, Van Meurs KP, Faix RG, Rich W, Newman NS, Cheng H, Heyne RJ, Vohr BR, Acarregui MJ, Vaucher YE, Pappas A, Peralta-Carcelen M, Wilson-Costello DE, Evans PW, Goldstein RF, Myers GJ, Poindexter BB, McGowan EC, Adams-Chapman I, Fuller J, Higgins RD; SUPPORT Study Group of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neuroimaging and neurodevelopmental outcome in extremely preterm infants. Pediatrics. 2015 Jan;135(1):e32-42. doi: 10.1542/peds.2014-0898. Epub 2014 Dec 1.
LeVan JM, Brion LP, Wrage LA, Gantz MG, Wyckoff MH, Sanchez PJ, Heyne R, Jaleel M, Finer NN, Carlo WA, Das A, Stoll BJ, Higgins RD; Eunice Kennedy Shriver NICHD Neonatal Research Network. Change in practice after the Surfactant, Positive Pressure and Oxygenation Randomised Trial. Arch Dis Child Fetal Neonatal Ed. 2014 Sep;99(5):F386-90. doi: 10.1136/archdischild-2014-306057. Epub 2014 May 29.
Related Links
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NICHD Neonatal Research Network site
NICHD Pregnancy \& Perinatology Branch
Other Identifiers
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NICHD-NRN-0033
Identifier Type: -
Identifier Source: org_study_id
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