Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants (Surfactant 2)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.
| Condition | Intervention | Phase |
|---|---|---|
|
Infant, Newborn Respiratory Distress Syndrome Respiratory Insufficiency |
Drug: Early surfactant Drug: Standard practice |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Need for mechanical ventilation following randomization [ Time Frame: Until hospital discharge or 120 days of life ] [ Designated as safety issue: Yes ]
- Mean duration of mechanical ventilation [ Time Frame: Until hospital discharge or 120 days of life ] [ Designated as safety issue: Yes ]
- Risk morbidities associated with mechanical ventilation and/or early surfactant administration [ Time Frame: Until hospital discharge or 120 days of life ] [ Designated as safety issue: Yes ]
| Enrollment: | 61 |
| Study Start Date: | May 2000 |
| Study Completion Date: | July 2002 |
| Primary Completion Date: | July 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | up to 12 Hours |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 | Cincinnati Children's Medical Center |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Edward F. Donovan, Lead Principal Investigator, Cincinnati Children's Hospital Medical Center |
| ClinicalTrials.gov Identifier: | NCT00005774 History of Changes |
| Other Study ID Numbers: | NICHD-NRN-0024, U10HD027856, U10HD021364, U10HD034216, U10HD034167, U10HD021397, U10HD027853, U10HD027871, U10HD021415, U10HD027904, U10HD027881, U10HD021385, U10HD027851, U10HD027880, U01HD036790, M01RR008084, M01RR006022, M01RR000750, M01RR000997, M01RR000070, M01RR001032 |
| Study First Received: | June 1, 2000 |
| Last Updated: | January 9, 2011 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
NICHD Neonatal Research Network Pulmonary ventilation Respiratory distress syndrome Respiratory insufficiency |
Surfactant, pulmonary Mechanical Ventilation Survanta |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases |
Infant, Newborn, Diseases Pulmonary Surfactants Beractant Respiratory System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013