Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00233324
First received: October 3, 2005
Last updated: November 28, 2014
Last verified: May 2013
Results First Received: November 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: 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
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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     205     203     229     215  
NOT COMPLETED     45     72     45     65  
Retinopathy of Prematurity                 22                 43                 19                 48  
Undetermined retinopathy status                 23                 29                 26                 17  



  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  
Number of Participants  
[units: participants]
  336     327     318     335     1316  
Age, Customized  
[units: participants]
         
>24 weeks and <28 weeks gestational age     336     327     318     335     1316  
Gender  
[units: participants]
         
Female     172     149     141     142     604  
Male     164     178     177     193     712  
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.   Safety Issue:   Yes

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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:

Publications automatically indexed to this study:


Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00233324     History of Changes
Other Study ID Numbers: NICHD-NRN-0033, U10HD021364, U10HD021373, U10HD021385, U10HD027851, U10HD027853, U10HD027856, U10HD027871, U10HD027880, U10HD027904, U10HD034216, U10HD036790, U10HD040461, U10HD040492, U10HD040689, U10HD053089, U10HD053109, U10HD053119, U10HD053124, UL1RR024128, UL1RR024139, UL1RR024979, UL1RR024982, UL1RR024989, UL1RR025008, M01RR000030, M01RR000633, M01RR000064, M01RR000070, M01RR000750, M01RR000080, M01RR008084, U10HD021397, U10HD040521, U10HD040498
Study First Received: October 3, 2005
Results First Received: November 16, 2014
Last Updated: November 28, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board