Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT)

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ClinicalTrials.gov Identifier: NCT00233324

Recruitment Status : Completed

First Posted : October 5, 2005

Results First Posted : December 5, 2014

Last Update Posted : April 18, 2019

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

National Heart, Lung, and Blood Institute (NHLBI)

National Center for Research Resources (NCRR)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party):

NICHD Neonatal Research Network

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Infant, Newborn, Diseases Other Preterm Infants Infant, Small for Gestational Age Premature Birth Bronchopulmonary Dysplasia Retinopathy of Prematurity	Drug: Surfactant Device: Continuous Positive Airway Pressure (CPAP) Drug: Supplemental oxygen with target saturation of 85 to 89% Drug: Supplemental oxygen with target saturation of 91 to 95%	Phase 3

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Detailed Description:

Study subjects were infants of 24 0/7ths to 27 6/7th weeks at birth for which a decision has been made to provide full resuscitation as required. Infants 27 weeks or less gestation (completed weeks by best obstetric estimate) were enrolled because more than 80% of such infants in the Network are intubated, usually early in their neonatal course. The feasibility trial demonstrated that the five NICHD centers involved could reduce intubation in the delivery room to less than 50% of such infants if they are not intubated for surfactant. We excluded infants of 23 weeks or less in view of their extremely high mortality and morbidity, and their almost universal need for delivery room intubation for resuscitation. Secondary studies included: neuroimaging/MRI, growth, and breathing outcomes.

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1316 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants
Study Start Date :	February 2005
Actual Primary Completion Date :	February 2009
Actual Study Completion Date :	August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Genetic and Rare Diseases Information Center resources: Retinopathy of Prematurity Bronchopulmonary Dysplasia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Surfactant and Low Oxygen Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%	Drug: Surfactant Intubation and administration of surfactant by 1 hour of age. Drug: 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 Other Name: Low oxygen
Experimental: Surfactant and High Oxygen Administration of surfactant by endotracheal tube and supplemental oxygen with target saturationof 91% to 95%	Drug: Surfactant Intubation and administration of surfactant by 1 hour of age. Drug: 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 Name: High oxygen
Experimental: CPAP and Low Oxygen Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%	Device: 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 Other Name: CPAP Drug: 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 Other Name: Low oxygen
Experimental: CPAP and High Oxygen Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%	Device: 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 Other Name: CPAP Drug: 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 Name: High oxygen

Outcome Measures

Primary Outcome Measures :

Survival Without Bronchopulmonary Dysplasia (BPD) [ Time Frame: 36 weeks ]
Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) [ Time Frame: 55 weeks ]

Secondary Outcome Measures :

Death or Neurodevelopmental Impairment [ Time Frame: 18-22 months ]
Duration of Mechanical Ventilation [ Time Frame: Entire NICU stay, up to 120 days ]
The length in days that an individual was on mechanical ventilation which includes high frequency and conventional ventilation.
Survival Without Ventilation [ Time Frame: From birth through first 7 days of life. ]
Surviving the first 7 days of life without any need for ventilation by day 7
Received Surfactant Treatment [ Time Frame: From birth through 120 days of life. ]
Received any surfactant treatment.
Number of Participants With Air Leaks [ Time Frame: From birth through first 14 days of life. ]
Number of participants with air leaks including pnemothorax, pulmonary interstitial emphysema (PIE), and pneumopericardium.
Physiological Bronchopulmonary Dysplasia [ Time Frame: 36 weeks post menstrual age. ]
Infants who received support via ventilator or CPAP at 36 weeks PMA. Alternatively, infants who received low levels of supplemental oxygen (<30%) at 36 weeks PMA may have been eligible for a physiologic challenge in which there was an attempt to wean the infant to room air. Specifically, infants were eligible for the challenge if at 36 weeks PMA if they were receiving effective oxygen <27% and had majority saturation >90%, or they were receiving effective oxygen 27-30% and had majority saturation >96%, or they were receiving room air by nasal cannula. The challenge took place between 36 and 37 weeks PMA. Those who were not challenged because their level of support increased (support with CPAP or ventilation or increased oxygen) were considered to have BPD, as were those who failed the challenge.
Death [ Time Frame: 18-22 months ]
Participants who died by their follow-up visit at 18-22 months.
Severe Intraventricular Hemorrhage (IVH) [ Time Frame: From birth through first 120 days of life. ]
There are four grades of intraventricular hemorrhage: Grade I - echodensity/hemorrhage is confied to the germinal matrix. Grade II - echodensity/hemorrhage in the lateral ventricle(s) without distention. Grade III - echodensity/hemorrhage in the lateral ventricle(s) with distention. Grade IV - echodense lesion in the parenchyma. Severe IVH is defined as having IVH grades of III or IV.
Periventricular Leukomalacia (PVL) [ Time Frame: From birth through first 120 days of life. ]
Increased echogenicity or cysts in periventricular region.
Threshold Retinopathy of Prematurity (ROP) Requiring Surgery [ Time Frame: From birth through first 120 days of life. ]
Diagnosis of retinopathy of prematurity which resulted in requiring surgery.
Endotracheal Intubation [ Time Frame: Delivery Room, post-delivery ]
Insertion of a tube into the trachea to allow positive pressure ventilation for breathing.
Duration of Oxygen Supplementation [ Time Frame: From birth through first 120 days of life. ]
The length of time in days that a participant had oxygen supplementation.
Pulse Oximetry Values > 90% [ Time Frame: From birth through first 120 days of life. ]
Percentage of time spent above 90% oxygen saturation.
Blindness in at Least One Eye [ Time Frame: 18-22 months ]
Blindness in at least one eye by 18-22 months of life.
Received Postnatal Steroids [ Time Frame: From birth through first 120 days of life. ]
Participant received any doses or courses of systemic steroids to prevent or treat bronchopulmonary dysplasia/chronic lung disease.
Necrotizing Enterocolitis (NEC) [ Time Frame: From birth through first 120 days of life. ]
Proven necrotizing enterocolitis (NEC) diagnosis using the Modified Bell's Staging Criteria for NEC.
Cerebral Palsy [ Time Frame: 18-22 months ]
Incidence of cerebral palsy.

Other Outcome Measures:

Apgar Scores at 5 Minutes [ Time Frame: 5 minutes after birth. ]
Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration" and scores range from 1 (worst) to 10 (best) indicating a baby's condition 5 minutes after birth.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	24 Weeks to 27 Weeks (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233324

Locations

Show 22 study locations

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
Stanford University
Palo Alto, California, United States, 94304
University of California at San Diego
San Diego, California, United States, 92103-8774
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06504
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest University
Charlotte, North Carolina, United States, 27157
RTI International
Durham, North Carolina, United States, 27705
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108

Sponsors and Collaborators

NICHD Neonatal Research Network

National Heart, Lung, and Blood Institute (NHLBI)

National Center for Research Resources (NCRR)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

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Principal Investigator:	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

More Information

Additional Information:

NICHD Neonatal Research Network site This link exits the ClinicalTrials.gov site

NICHD Pregnancy & Perinatology Branch This link exits the ClinicalTrials.gov site

Publications of Results:

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. Erratum In: N Engl J Med. 2010 Jun 10;362(23):2235.

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.

Other Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	NICHD Neonatal Research Network
ClinicalTrials.gov Identifier:	NCT00233324
Other Study ID Numbers:	NICHD-NRN-0033 U10HD021364 ( U.S. NIH Grant/Contract ) U10HD021373 ( U.S. NIH Grant/Contract ) U10HD021385 ( U.S. NIH Grant/Contract ) U10HD027851 ( U.S. NIH Grant/Contract ) U10HD027853 ( U.S. NIH Grant/Contract ) U10HD027856 ( U.S. NIH Grant/Contract ) U10HD027871 ( U.S. NIH Grant/Contract ) U10HD027880 ( U.S. NIH Grant/Contract ) U10HD027904 ( U.S. NIH Grant/Contract ) U10HD034216 ( U.S. NIH Grant/Contract ) U10HD036790 ( U.S. NIH Grant/Contract ) U10HD040461 ( U.S. NIH Grant/Contract ) U10HD040492 ( U.S. NIH Grant/Contract ) U10HD040689 ( U.S. NIH Grant/Contract ) U10HD053089 ( U.S. NIH Grant/Contract ) U10HD053109 ( U.S. NIH Grant/Contract ) U10HD053119 ( U.S. NIH Grant/Contract ) U10HD053124 ( U.S. NIH Grant/Contract ) UL1RR024128 ( U.S. NIH Grant/Contract ) UL1RR024139 ( U.S. NIH Grant/Contract ) UL1RR024979 ( U.S. NIH Grant/Contract ) UL1RR024982 ( U.S. NIH Grant/Contract ) UL1RR024989 ( U.S. NIH Grant/Contract ) UL1RR025008 ( U.S. NIH Grant/Contract ) M01RR000633 ( U.S. NIH Grant/Contract ) M01RR000750 ( U.S. NIH Grant/Contract ) M01RR008084 ( U.S. NIH Grant/Contract ) U10HD021397 ( U.S. NIH Grant/Contract ) U10HD040521 ( U.S. NIH Grant/Contract ) U10HD040498 ( U.S. NIH Grant/Contract )
First Posted:	October 5, 2005 Key Record Dates
Results First Posted:	December 5, 2014
Last Update Posted:	April 18, 2019
Last Verified:	April 2019

Keywords provided by NICHD Neonatal Research Network:


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

Additional relevant MeSH terms:

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Bronchopulmonary Dysplasia Retinopathy of Prematurity Premature Birth Infant, Newborn, Diseases Birth Weight Retinal Diseases Eye Diseases Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications	Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Body Weight Ventilator-Induced Lung Injury Lung Injury Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases Pulmonary Surfactants Respiratory System Agents

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