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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 : October 25, 2017
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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Infant, Newborn, Diseases
Other Preterm Infants
Infant, Small for Gestational Age
Premature Birth
Bronchopulmonary Dysplasia
Retinopathy of Prematurity
Interventions 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%
Enrollment 1316

Recruitment Details 3546 infants assessed for eligibility from 3127 pregnancies. 2230 were excluded for not meeting eligibility criteria or parental permission was not granted or other reasons.
Pre-assignment Details 235 did not meet eligiblity criteria 125 did not have personnel or equipment available 699 were eligible did not have consent sought 344 were eligible but parent or guardian was not available 748 were eligible but parent or guardian denied permission to enroll 68 were eligible and had permission but were not randomized 11 had other reasons
Arm/Group Title Early Surfactant and Lower Range Oxygen Early Surfactant and Higher Range Oxygen CPAP and Lower Range Oxygen CPAP and Higher Range Oxygen
Hide Arm/Group Description Early Surfactant and 85-89% target oxygen saturation Early Surfactant and 91-95% target oxygen saturation Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation
Period Title: Main Study
Started 318 335 336 327
Completed 250 275 274 280
Not Completed 68 60 62 47
Reason Not Completed
Death             68             60             62             47
Period Title: Follow up at 18-22 Months Corrected Age
Started 250 275 274 280
Completed 237 261 256 269
Not Completed 13 14 18 11
Reason Not Completed
Death             5             7             5             4
Undetermined retinopathy status             8             7             13             7
Arm/Group Title CPAP and Lower Range Oxygen CPAP and Higher Range Oxygen Early Surfactant and Lower Range Oxygen Early Surfactant and Higher Range Oxygen Total
Hide Arm/Group Description Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen administered in lower range (85-90%) Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen adminstered in higher range (91-95%) Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in lower range (85-90%) Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in higher range (91-95%) Total of all reporting groups
Overall Number of Baseline Participants 336 327 318 335 1316
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
>23 weeks and <28 weeks gestational age Number Analyzed 336 participants 327 participants 318 participants 335 participants 1316 participants
336 327 318 335 1316
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 336 participants 327 participants 318 participants 335 participants 1316 participants
Female
172
  51.2%
149
  45.6%
141
  44.3%
142
  42.4%
604
  45.9%
Male
164
  48.8%
178
  54.4%
177
  55.7%
193
  57.6%
712
  54.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 336 participants 327 participants 318 participants 335 participants 1316 participants
336 327 318 335 1316
1.Primary Outcome
Title Survival Without Bronchopulmonary Dysplasia (BPD)
Hide Description [Not Specified]
Time Frame 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPAP Surfactant
Hide Arm/Group Description:
Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
Intubation and administration of surfactant by 1 hour of age
Overall Number of Participants Analyzed 663 653
Measure Type: Number
Unit of Measure: Participants
346 320
2.Primary Outcome
Title Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery)
Hide Description [Not Specified]
Time Frame 55 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
49 infants in the lower oxygen saturation group and 46 infants in the higher oxygen saturation group that had unknown retinopathy of prematurity outcome
Arm/Group Title Lower Oxygen Saturation Target Higher Oxygen Saturation Target
Hide Arm/Group Description:
SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.
Overall Number of Participants Analyzed 605 616
Measure Type: Number
Unit of Measure: participants
434 418
3.Secondary Outcome
Title Death or Neurodevelopmental Impairment
Hide Description [Not Specified]
Time Frame 18-22 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPAP Surfactant Lower Oxygen Saturation Target Higher Oxygen Saturation Target
Hide Arm/Group Description:
Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
Intubation and administration of surfactant by 1 hour of age
SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.
Overall Number of Participants Analyzed 621 613 612 622
Measure Type: Number
Unit of Measure: participants
173 183 185 171
4.Secondary Outcome
Title Duration of Mechanical Ventilation
Hide Description [Not Specified]
Time Frame During entire NICU stay
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Survival Without Ventilation
Hide Description [Not Specified]
Time Frame By day 7
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Received Surfactant Treatment
Hide Description [Not Specified]
Time Frame 120 days
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Incidence of Air Leaks
Hide Description [Not Specified]
Time Frame 120 days
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Bronchopulmonary Disease (Using the Physiologic Definition of BPD)
Hide Description [Not Specified]
Time Frame 36 weeks
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Death
Hide Description [Not Specified]
Time Frame 18-22 months
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Severe Intraventricular Hemorrhage (IVH)
Hide Description [Not Specified]
Time Frame 120 days
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Periventricular Leukomalacia (PVL)
Hide Description [Not Specified]
Time Frame 120 days
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Threshold ROP Requiring Surgery
Hide Description [Not Specified]
Time Frame 120 days
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Endotracheal Intubation
Hide Description [Not Specified]
Time Frame Before 10 minutes of age
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Duration of Oxygen Supplementation
Hide Description [Not Specified]
Time Frame 120 days
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Pulse Oximetry Values > 90%
Hide Description [Not Specified]
Time Frame 120 days
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Blindness in at Least One Eye
Hide Description [Not Specified]
Time Frame 18-22 months
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Received Postnatal Steroids
Hide Description [Not Specified]
Time Frame 120 days
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Necrotizing Enterocolitis (NEC)
Hide Description [Not Specified]
Time Frame 120 days
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Cerebral Palsy
Hide Description [Not Specified]
Time Frame 18-22 months
Outcome Measure Data Not Reported
20.Other Pre-specified Outcome
Title Apgar Score
Hide Description [Not Specified]
Time Frame 5 minutes
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Surfactant and Lower Range Oxygen Surfactant and Higher Range Oxygen CPAP and Lower Range Oxygen CPAP and Higher Range Oxygen
Hide Arm/Group Description Early Surfactant and 85-89% target oxygen saturation Early Surfactant and 91-95% target oxygen saturation Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation
All-Cause Mortality
Surfactant and Lower Range Oxygen Surfactant and Higher Range Oxygen CPAP and Lower Range Oxygen CPAP and Higher Range Oxygen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Surfactant and Lower Range Oxygen Surfactant and Higher Range Oxygen CPAP and Lower Range Oxygen CPAP and Higher Range Oxygen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   204/318 (64.15%)   227/335 (67.76%)   231/336 (68.75%)   224/327 (68.50%) 
Cardiac disorders         
Chest compressions or drugs in the delivery room  [1]  22/318 (6.92%)  24/335 (7.16%)  19/333 (5.71%)  17/327 (5.20%) 
Patent Ductus Aretriosus  [2]  151/311 (48.55%)  160/325 (49.23%)  156/330 (47.27%)  164/323 (50.77%) 
Gastrointestinal disorders         
Necrotizing enterocolitis  [2]  36/311 (11.58%)  27/325 (8.31%)  40/330 (12.12%)  43/324 (13.27%) 
General disorders         
Death   68/318 (21.38%)  60/335 (17.91%)  62/336 (18.45%)  47/327 (14.37%) 
Nervous system disorders         
Intraventricular hemorrhage (IVH) Grade 3 or 4  [2]  34/307 (11.07%)  38/321 (11.84%)  49/323 (15.17%)  43/319 (13.48%) 
Respiratory, thoracic and mediastinal disorders         
Air leak during initial 14 days   26/318 (8.18%)  22/335 (6.57%)  25/336 (7.44%)  20/327 (6.12%) 
Pulmonary Hemorrhage  [2]  24/311 (7.72%)  21/325 (6.46%)  20/330 (6.06%)  13/324 (4.01%) 
Nasal Breakdown   0/318 (0.00%)  1/335 (0.30%)  0/336 (0.00%)  1/327 (0.31%) 
Indicates events were collected by systematic assessment
[1]
Number at risk is lower than total entered on this arm due to missing data because of early death or other reasons.
[2]
Number at risk is lower than total entered on this arm due to study withdrawal of some participants due to death or other reasons.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Surfactant and Lower Range Oxygen Surfactant and Higher Range Oxygen CPAP and Lower Range Oxygen CPAP and Higher Range Oxygen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/318 (1.26%)   5/335 (1.49%)   11/336 (3.27%)   7/327 (2.14%) 
General disorders         
Any other non-serious adverse event  [1]  0/318 (0.00%)  2/335 (0.60%)  1/336 (0.30%)  1/327 (0.31%) 
Respiratory, thoracic and mediastinal disorders         
Nasal Breakdown   4/318 (1.26%)  3/335 (0.90%)  10/336 (2.98%)  6/327 (1.83%) 
Indicates events were collected by systematic assessment
[1]
Additional adverse events are available only at the summary level.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Waldemar A. Carlo, M.D
Organization: University of Alabama
Phone: (205) 934-4680
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT00233324     History of Changes
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 Submitted: October 3, 2005
First Posted: October 5, 2005
Results First Submitted: November 16, 2014
Results First Posted: December 5, 2014
Last Update Posted: October 25, 2017