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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 : April 18, 2019
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
Hide 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
Hide 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
Hide 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 The length in days that an individual was on mechanical ventilation which includes high frequency and conventional ventilation.
Time Frame Entire NICU stay, up to 120 days
Hide Outcome Measure Data
Hide Analysis Population Description
1078 participants survived to discharge and they all had information available for regarding use of mechanical ventilation.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 249 275 274 280
Median (Inter-Quartile Range)
Unit of Measure: days
11
(2 to 32)
13
(2 to 37)
7
(1 to 29)
11.5
(2 to 32.5)
5.Secondary Outcome
Title Survival Without Ventilation
Hide Description Surviving the first 7 days of life without any need for ventilation by day 7
Time Frame From birth through first 7 days of life.
Hide Outcome Measure Data
Hide Analysis Population Description
1307 participants had known survival and ventilation statuses. 9 participants were excluded due to unknown ventilation status from birth through 7 days of life: 6 infants in the lower oxygen group, 3 infants in the high oxygen group.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 317 335 331 324
Measure Type: Count of Participants
Unit of Measure: Participants
161
  50.8%
157
  46.9%
190
  57.4%
172
  53.1%
6.Secondary Outcome
Title Received Surfactant Treatment
Hide Description Received any surfactant treatment.
Time Frame From birth through 120 days of life.
Hide Outcome Measure Data
Hide Analysis Population Description
1312 participants had known surfactant treatment. 4 were excluded due to unknown surfactant treatment: 2 infants in the low oxygen group, 2 infants in the high oxygen group.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 317 335 335 325
Measure Type: Count of Participants
Unit of Measure: Participants
159
  50.2%
176
  52.5%
42
  12.5%
51
  15.7%
7.Secondary Outcome
Title Number of Participants With Air Leaks
Hide Description Number of participants with air leaks including pnemothorax, pulmonary interstitial emphysema (PIE), and pneumopericardium.
Time Frame From birth through first 14 days of life.
Hide Outcome Measure Data
Hide Analysis Population Description
All 1316 participants had data on incidence of air leaks.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 318 335 336 327
Measure Type: Count of Participants
Unit of Measure: Participants
26
   8.2%
22
   6.6%
25
   7.4%
20
   6.1%
8.Secondary Outcome
Title Physiological Bronchopulmonary Dysplasia
Hide Description 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.
Time Frame 36 weeks post menstrual age.
Hide Outcome Measure Data
Hide Analysis Population Description
1108 participants survived to 36 weeks and had BPD information. 208 participants did not survive to 36 weeks and were excluded: 114 from the low oxygen group, 94 from the high oxygen group.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 258 281 282 287
Measure Type: Count of Participants
Unit of Measure: Participants
102
  39.5%
117
  41.6%
103
  36.5%
120
  41.8%
9.Secondary Outcome
Title Death
Hide Description Participants who died by their follow-up visit at 18-22 months.
Time Frame 18-22 months
Hide Outcome Measure Data
Hide Analysis Population Description
1281 participants with confirmed deaths or survivals by follow-up. 35 were excluded due to incomplete follow-up visits: 21 in low oxygen group, 14 in high oxygen group.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 310 328 323 320
Measure Type: Count of Participants
Unit of Measure: Participants
73
  23.5%
67
  20.4%
67
  20.7%
51
  15.9%
10.Secondary Outcome
Title Severe Intraventricular Hemorrhage (IVH)
Hide Description 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.
Time Frame From birth through first 120 days of life.
Hide Outcome Measure Data
Hide Analysis Population Description
1270 participants had known IVH grades. 46 were excluded due to unknown IVH status: 24 infants from the low oxygen group, 22 infants from high oxygen group.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 307 321 323 319
Measure Type: Count of Participants
Unit of Measure: Participants
34
  11.1%
38
  11.8%
49
  15.2%
43
  13.5%
11.Secondary Outcome
Title Periventricular Leukomalacia (PVL)
Hide Description Increased echogenicity or cysts in periventricular region.
Time Frame From birth through first 120 days of life.
Hide Outcome Measure Data
Hide Analysis Population Description
1272 participants had known PVL statuses. 44 were excluded due to unknown PVL status: 23 infants in the low oxygen group, 21 infants in the high oxygen group.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 307 322 324 319
Measure Type: Count of Participants
Unit of Measure: Participants
10
   3.3%
16
   5.0%
14
   4.3%
14
   4.4%
12.Secondary Outcome
Title Threshold Retinopathy of Prematurity (ROP) Requiring Surgery
Hide Description Diagnosis of retinopathy of prematurity which resulted in requiring surgery.
Time Frame From birth through first 120 days of life.
Hide Outcome Measure Data
Hide Analysis Population Description
997 surviving participants with ROP data were included. 319 total participants were excluded due to death (N=224) or missing ROP data (N=95): 171 in the low oxygen group, 148 in the high oxygen group.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 230 250 253 264
Measure Type: Count of Participants
Unit of Measure: Participants
19
   8.3%
44
  17.6%
17
   6.7%
47
  17.8%
13.Secondary Outcome
Title Endotracheal Intubation
Hide Description Insertion of a tube into the trachea to allow positive pressure ventilation for breathing.
Time Frame Delivery Room, post-delivery
Hide Outcome Measure Data
Hide Analysis Population Description
1312 participants had non-missing data on whether they experienced endotracheal intubation. 4 participants were excluded due to missing information: 2 infants in the low oxygen group, 2 infants in the high oxygen group.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 317 335 335 325
Measure Type: Count of Participants
Unit of Measure: Participants
294
  92.7%
315
  94.0%
110
  32.8%
117
  36.0%
14.Secondary Outcome
Title Duration of Oxygen Supplementation
Hide Description The length of time in days that a participant had oxygen supplementation.
Time Frame From birth through first 120 days of life.
Hide Outcome Measure Data
Hide Analysis Population Description
1078 participants survived to discharge and they all had information available regarding the duration of their oxygen supplementation.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 249 275 274 280
Median (Inter-Quartile Range)
Unit of Measure: days
46
(21 to 87)
60
(33 to 93)
43
(15 to 71)
59
(28.5 to 88)
15.Secondary Outcome
Title Pulse Oximetry Values > 90%
Hide Description Percentage of time spent above 90% oxygen saturation.
Time Frame From birth through first 120 days of life.
Hide Outcome Measure Data
Hide Analysis Population Description
90 were excluded due to incomplete data: 48 from the low oxygen saturation group and 42 from the high oxygen saturation group.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 302 314 304 306
Median (Inter-Quartile Range)
Unit of Measure: percentage of time
62
(53 to 73)
76
(70 to 81)
63
(55 to 73)
77
(71 to 83)
16.Secondary Outcome
Title Blindness in at Least One Eye
Hide Description Blindness in at least one eye by 18-22 months of life.
Time Frame 18-22 months
Hide Outcome Measure Data
Hide Analysis Population Description
990 participants survived and were seen at the 18-22 month follow-up. 326 were excluded: 175 in the low oxygen group, 151 in the high oxygen group.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 225 254 254 257
Measure Type: Count of Participants
Unit of Measure: Participants
4
   1.8%
3
   1.2%
1
   0.4%
5
   1.9%
17.Secondary Outcome
Title Received Postnatal Steroids
Hide Description Participant received any doses or courses of systemic steroids to prevent or treat bronchopulmonary dysplasia/chronic lung disease.
Time Frame From birth through first 120 days of life.
Hide Outcome Measure Data
Hide Analysis Population Description
1280 participants had information regarding whether they received postnatal steroids. 36 participants were excluded due to missing data: 18 infants in the low oxygen group, 18 infants in the high oxygen group.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 308 323 328 321
Measure Type: Count of Participants
Unit of Measure: Participants
42
  13.6%
41
  12.7%
19
   5.8%
28
   8.7%
18.Secondary Outcome
Title Necrotizing Enterocolitis (NEC)
Hide Description Proven necrotizing enterocolitis (NEC) diagnosis using the Modified Bell's Staging Criteria for NEC.
Time Frame From birth through first 120 days of life.
Hide Outcome Measure Data
Hide Analysis Population Description
1290 participants had known NEC statuses. 26 were excluded due to missing NEC data: 13 infants in the low oxygen group, 13 infants in the high oxygen group.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 311 325 330 324
Measure Type: Count of Participants
Unit of Measure: Participants
36
  11.6%
27
   8.3%
40
  12.1%
43
  13.3%
19.Secondary Outcome
Title Cerebral Palsy
Hide Description Incidence of cerebral palsy.
Time Frame 18-22 months
Hide Outcome Measure Data
Hide Analysis Population Description
990 participants survived and were seen at the 18-22 month follow-up. 326 were excluded: 175 in the low oxygen group, 151 in the high oxygen group.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 225 254 254 257
Measure Type: Count of Participants
Unit of Measure: Participants
17
   7.6%
17
   6.7%
26
  10.2%
24
   9.3%
20.Other Pre-specified Outcome
Title Apgar Scores at 5 Minutes
Hide Description 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.
Time Frame 5 minutes after birth.
Hide Outcome Measure Data
Hide Analysis Population Description
All 1316 participants had APGAR scores at 5 minutes.
Arm/Group Title Surfactant and Low Oxygen Surfactant and High Oxygen CPAP and Low Oxygen CPAP and High Oxygen
Hide Arm/Group Description:
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 85% to 89%
Administration of surfactant by endotracheal tube and supplemental oxygen with target saturation of 91% to 95%
Administration of continuous positive airway pressure (CPAP) and supplemental oxygen with target saturation of 85% to 89%
Administration of continuous positive airway pressure (CPAP)and supplemental oxygen with target saturation of 91% to 95%
Overall Number of Participants Analyzed 318 335 336 327
Median (Inter-Quartile Range)
Unit of Measure: scores on a scale
7
(6 to 8)
7
(6 to 8)
7
(6 to 8)
7
(6 to 8)
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
Layout table for Results Point of Contact information
Name/Title: Waldemar A. Carlo, M.D
Organization: University of Alabama
Phone: (205) 934-4680
EMail: wcarlo@peds.uab.edu
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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: April 18, 2019