Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants (Surfactant 2)
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| ClinicalTrials.gov Identifier: NCT00005774 |
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Recruitment Status :
Terminated
(The trial was stopped after 7 months for lack of recruitment.)
First Posted : June 2, 2000
Last Update Posted : June 8, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infant, Newborn Respiratory Distress Syndrome Respiratory Insufficiency | Drug: Early surfactant Drug: Standard practice | Phase 3 |
Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. The role of surfactant therapy in the management of larger infants with respiratory distress syndrome (RDS) was unclear. In many neonatal intensive care units, these infants were routinely managed with continuous positive airway pressure (CPAP) alone.
This trial tested whether early use of surfactant combined with CPAP would ameliorate the course of RDS without an increased risk of death. Primary study outcomes were measures of use of mechanical ventilation, and thereby likely reduction in risk of ventilator-associated morbidity.
Eligible infants were randomized before the infant is 12 hours of age to receive either: early surfactant followed by extubation within 30 minutes and application of CPAP (intervention group); or surfactant according to current center practice, only after initiation of mechanical ventilation (control group).
The trial was stopped after 7 months for lack of recruitment.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 61 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Early Surfactant Followed by Nasal CPAP to Reduce the Use of Mechanical Ventilation Without Additional Morbidity in Infants 1250- 2000 Grams With RDS |
| Study Start Date : | May 2000 |
| Actual Primary Completion Date : | July 2002 |
| Actual Study Completion Date : | July 2002 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Early surfactant group |
Drug: Early surfactant
Early surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP)
Other Name: Survanta |
| Active Comparator: Standard Practice group |
Drug: Standard practice
Surfactant according to current center practice, only after initiation of mechanical ventilation. |
- Need for mechanical ventilation following randomization [ Time Frame: Until hospital discharge or 120 days of life ]
- Mean duration of mechanical ventilation [ Time Frame: Until hospital discharge or 120 days of life ]
- Risk morbidities associated with mechanical ventilation and/or early surfactant administration [ Time Frame: Until hospital discharge or 120 days of life ]
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| Ages Eligible for Study: | up to 12 Hours (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Infants born at 1,250-2g000 grams birth weight
- <12 hours of age
- Clinical and radiographic diagnosis of respiratory distress syndrome (RDS)
- Receiving supplemental oxygen with head-hood Fi02 of 0.35 to 0.50 or CPAP Fi02 of 0.25 to 0.50 to maintain oxygen saturation less than 90 percent and more than 96 percent
Exclusion Criteria:
- Receiving mechanical ventilation
- Air leak
- Pulmonary hemorrhage
- Major congenital anomaly
- Congenital non-bacterial infection
- Parental refusal of consent
- Refusal of attending neonatologist
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): NCT00005774
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| 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, 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, 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 Health Science Center at Houston | |
| Houston, Texas, United States, 77030 | |
| Study Director: | Edward F. Donovan, MD | Children's Hospital Medical Center, Cincinnati | |
| Principal Investigator: | David K. Stevenson, MD | Stanford University | |
| Principal Investigator: | Waldemar A. Carlo, MD | University of Alabama at Birmingham | |
| Principal Investigator: | Richard A. Ehrenkranz, MD | Yale University | |
| Principal Investigator: | Barbara J. Stoll, MD | Emory University | |
| Principal Investigator: | James A. Lemons, MD | Indiana University | |
| Principal Investigator: | Charles R. Bauer, MD | University of Miami | |
| Principal Investigator: | Lu-Ann Papile, MD | University of New Mexico | |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University | |
| Principal Investigator: | Avroy A. Fanaroff, MD | Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Principal Investigator: | William Oh, MD | Brown University, Women & Infants Hospital of Rhode Island | |
| Principal Investigator: | Sheldon B. Korones, MD | University of Tennessee | |
| Principal Investigator: | Jon E. Tyson, MD MPH | The University of Texas Health Science Center, Houston |
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NICHD Neonatal Research Network Pulmonary ventilation Respiratory distress syndrome Respiratory insufficiency |
Surfactant, pulmonary Mechanical Ventilation Survanta |
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Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Insufficiency Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Pulmonary Surfactants Respiratory System Agents |