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Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT)

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00233324
First received: October 3, 2005
Last updated: June 19, 2017
Last verified: June 2017
Results First Received: November 16, 2014  
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%

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Reporting Groups
  Description
Early Surfactant and Lower Range Oxygen Early Surfactant and 85-89% target oxygen saturation
Early Surfactant and Higher Range Oxygen Early Surfactant and 91-95% target oxygen saturation
CPAP and Lower Range Oxygen Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation
CPAP and Higher Range Oxygen Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation

Participant Flow for 2 periods

Period 1:   Main Study
    Early Surfactant and Lower Range Oxygen   Early Surfactant and Higher Range Oxygen   CPAP and Lower Range Oxygen   CPAP and Higher Range Oxygen
STARTED   318   335   336   327 
COMPLETED   250   275   274   280 
NOT COMPLETED   68   60   62   47 
Death                68                60                62                47 

Period 2:   Follow up at 18-22 Months Corrected Age
    Early Surfactant and Lower Range Oxygen   Early Surfactant and Higher Range Oxygen   CPAP and Lower Range Oxygen   CPAP and Higher Range Oxygen
STARTED   250   275   274   280 
COMPLETED   237   261   256   269 
NOT COMPLETED   13   14   18   11 
Death                5                7                5                4 
Undetermined retinopathy status                8                7                13                7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CPAP and Lower Range Oxygen 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%)
CPAP and Higher Range Oxygen 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%)
Early Surfactant and Lower Range Oxygen Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in lower range (85-90%)
Early Surfactant and Higher Range Oxygen Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in higher range (91-95%)
Total Total of all reporting groups

Baseline Measures
   CPAP and Lower Range Oxygen   CPAP and Higher Range Oxygen   Early Surfactant and Lower Range Oxygen   Early Surfactant and Higher Range Oxygen   Total 
Overall Participants Analyzed 
[Units: Participants]
 336   327   318   335   1316 
Age, Customized 
[Units: Participants]
         
>23 weeks and <28 weeks gestational age   336   327   318   335   1316 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
         
United States   336   327   318   335   1316 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Survival Without Bronchopulmonary Dysplasia (BPD)   [ Time Frame: 36 weeks ]

2.  Primary:   Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery)   [ Time Frame: 55 weeks ]

3.  Secondary:   Death or Neurodevelopmental Impairment   [ Time Frame: 18-22 months ]

4.  Secondary:   Duration of Mechanical Ventilation   [ Time Frame: During entire NICU stay ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Survival Without Ventilation   [ Time Frame: By day 7 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Received Surfactant Treatment   [ Time Frame: 120 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Incidence of Air Leaks   [ Time Frame: 120 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Bronchopulmonary Disease (Using the Physiologic Definition of BPD)   [ Time Frame: 36 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Death   [ Time Frame: 18-22 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Severe Intraventricular Hemorrhage (IVH)   [ Time Frame: 120 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Secondary:   Periventricular Leukomalacia (PVL)   [ Time Frame: 120 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Secondary:   Threshold ROP Requiring Surgery   [ Time Frame: 120 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

13.  Secondary:   Endotracheal Intubation   [ Time Frame: Before 10 minutes of age ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

14.  Secondary:   Duration of Oxygen Supplementation   [ Time Frame: 120 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

15.  Secondary:   Pulse Oximetry Values > 90%   [ Time Frame: 120 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

16.  Secondary:   Blindness in at Least One Eye   [ Time Frame: 18-22 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

17.  Secondary:   Received Postnatal Steroids   [ Time Frame: 120 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

18.  Secondary:   Necrotizing Enterocolitis (NEC)   [ Time Frame: 120 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

19.  Secondary:   Cerebral Palsy   [ Time Frame: 18-22 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

20.  Other Pre-specified:   Apgar Score   [ Time Frame: 5 minutes ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: wcarlo@peds.uab.edu


Publications of Results:

Other Publications:
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 )
Study First Received: October 3, 2005
Results First Received: November 16, 2014
Last Updated: June 19, 2017