Surfactant Positive Airway Pressure and Pulse Oximetry Trial

NCT00233324 | Completed Phase 3 Results DMC

• 31 other identifiers: NICHD-NRN-0033U10HD021364U10HD021373U10HD021385U10HD027851U10HD027853U10HD027856U10HD027871U10HD027880U10HD027904U10HD034216U10HD036790U10HD040461U10HD040492U10HD040689U10HD053089U10HD053109U10HD053119U10HD053124UL1RR024128UL1RR024139UL1RR024979UL1RR024982UL1RR024989UL1RR025008M01RR000633M01RR000750M01RR008084U10HD021397U10HD040521U10HD040498
• Study Type: interventional
• Target: 1,316
• Locations: 1 country
• Sites: 22

Brief Summary

This study compared 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, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.

Conditions

Infant, Newborn, Diseases; Other Preterm Infants; Infant, Small for Gestational Age; Premature Birth; Bronchopulmonary Dysplasia; Retinopathy of Prematurity

Keywords

NICHD Neonatal Research Network; Extremely Low Birth Weight (ELBW); Very Low Birth Weight (VLBW); Prematurity; Mechanical ventilation; Surfactant; Intubation; Neurodevelopmental impairment; Pulse oximetry; Oxygen saturation; Positive-Pressure Respiration

Outcome Measures

Primary Outcomes (2)

• Survival Without Bronchopulmonary Dysplasia (BPD)

  36 weeks

• Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery)

  55 weeks

Secondary Outcomes (17)

• Death or Neurodevelopmental Impairment

  18-22 months

• Duration of Mechanical Ventilation

  Entire NICU stay, up to 120 days

• Survival Without Ventilation

  From birth through first 7 days of life.

• Received Surfactant Treatment

  From birth through 120 days of life.

• Number of Participants With Air Leaks

  From birth through first 14 days of life.

Other Outcomes (1)

• Apgar Scores at 5 Minutes

  5 minutes after birth.

Study Arms (4)

Surfactant and Low Oxygen

EXPERIMENTAL

Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%

Drug: Surfactant; Drug: Supplemental oxygen with target saturation of 85 to 89%

Surfactant and High Oxygen

EXPERIMENTAL

Administration of surfactant by endotracheal tube and supplemental oxygen with target saturationof 91% to 95%

Drug: Surfactant; Drug: Supplemental oxygen with target saturation of 91 to 95%

CPAP and Low Oxygen

EXPERIMENTAL

Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%

Device: Continuous Positive Airway Pressure (CPAP); Drug: Supplemental oxygen with target saturation of 85 to 89%

CPAP and High Oxygen

EXPERIMENTAL

Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%

Device: Continuous Positive Airway Pressure (CPAP); Drug: Supplemental oxygen with target saturation of 91 to 95%

Interventions

Surfactant DRUG

Intubation and administration of surfactant by 1 hour of age.

Surfactant and High Oxygen; Surfactant and Low Oxygen

Continuous Positive Airway Pressure (CPAP) DEVICE

Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU

Also known as: CPAP

CPAP and High Oxygen; CPAP and Low Oxygen

Supplemental oxygen with target saturation of 85 to 89% DRUG

Supplemental oxygen in the range of 85% to 89% until the infant is no longer requiring ventilatory support or oxygen

Also known as: Low oxygen

CPAP and Low Oxygen; Surfactant and Low Oxygen

Supplemental oxygen with target saturation of 91 to 95% DRUG

Supplemental oxygen in the range of 91% to 95% until the infant is no longer requiring ventilatory support or oxygen.

Also known as: High oxygen

CPAP and High Oxygen; Surfactant and High Oxygen

Eligibility Criteria

• Age: 24 Weeks - 27 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NICHD Neonatal Research Network: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Center for Research Resources (NCRR): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (22)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of California at San Diego

San Diego, California, 92103-8774, United States

Location

Yale University

New Haven, Connecticut, 06504, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Wake Forest University

Charlotte, North Carolina, 27157, United States

Location

RTI International

Durham, North Carolina, 27705, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (18)

• 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.

  PMID: 2674614 BACKGROUND

• 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.

  PMID: 20472937 RESULT

• 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.

  PMID: 20472939 RESULT

• 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.

  PMID: 20587676 RESULT

• 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.

  PMID: 22738947 RESULT

• 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.

  PMID: 22371462 RESULT

• 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.

  PMID: 25425651 RESULT

• 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.

  PMID: 27344218 RESULT

• 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.

  PMID: 24725582 RESULT

• 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.

  PMID: 23268664 RESULT

• 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.

  PMID: 37640232 DERIVED

• 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.

  PMID: 35715492 DERIVED

• 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.

  PMID: 30692613 DERIVED

• 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.

  PMID: 30292492 DERIVED

• 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.

  PMID: 28600154 DERIVED

• 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.

  PMID: 28279433 DERIVED

• 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.

  PMID: 25554820 DERIVED

• 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.

  PMID: 24876196 DERIVED

Related Links

• NICHD Neonatal Research Network site
• NICHD Pregnancy \& Perinatology Branch

MeSH Terms

Conditions

Infant, Newborn, Diseases; Premature Birth; Bronchopulmonary Dysplasia; Retinopathy of Prematurity

Interventions

Surface-Active Agents; Continuous Positive Airway Pressure; high-potential iron-sulfur protein oxygen oxidoreductase

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Waldemar A. Carlo, M.D
• Organization: University of Alabama

wcarlo@peds.uab.edu

(205) 934-4680

Study Officials

• Abbot R. Laptook, MD

  Brown University, Women & Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

• Michele C. Walsh, MD MS

  Case Western Reserve University, Rainbow Babies and Children's Hospital

  PRINCIPAL INVESTIGATOR

• Ronald N. Goldberg, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Barbara J. Stoll, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Brenda B. Poindexter, MD MS

  Indiana University

  PRINCIPAL INVESTIGATOR

• Abhik Das, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

• Krisa P. Van Meurs, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Ivan D. Frantz III, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

• Neil N. Finer, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Kurt Schibler, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Waldemar A. Carlo, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Edward F. Bell, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Kristi L. Watterberg, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Pablo J. Sanchez, MD

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

• Kathleen A. Kennedy, MD MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Roger G. Faix, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Seetha Shankaran, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Richard A. Ehrenkranz, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 5, 2005
• Study Start: February 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: August 1, 2016
• Last Updated: April 18, 2019
• Results First Posted: December 5, 2014

Record last verified: 2019-04

Locations

US (22)