Infant, NewbornPhase 3Surfactant 2NCT00005774
Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants
A Phase 3 study testing Early surfactant and Standard practice in people with Infant, Newborn and Respiratory Distress Syndrome, run by NICHD Neonatal Research Network at 13 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 12 hours
- Conditions the study is for
- Infant, Newborn, Respiratory Distress Syndrome, Respiratory Insufficiency
- What is being tested?
- Early surfactant and Standard practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 13 sitesUnited States
- Study dates
- May 2000to Jul 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Receiving mechanical ventilation
- Air leak
- Pulmonary hemorrhage
- Major congenital anomaly
- Congenital non-bacterial infection
- Parental refusal of consent
- Refusal of attending neonatologist
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Emory University
Atlanta, Georgia, 30303
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Wayne State University
Detroit, Michigan, 48201
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Tennessee
Memphis, Tennessee, 38163
University of Miami
Miami, Florida, 33136
Yale University
New Haven, Connecticut, 06504
Stanford University
Palo Alto, California, 94304
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
About this study
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
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.
Read the 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.
- Being tested
- Early surfactant, Standard practice
- Keywords
- NICHD Neonatal Research Network, Pulmonary ventilation, Respiratory distress syndrome, Respiratory insufficiency, Surfactant, pulmonary, Mechanical Ventilation, Survanta
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early surfactantDrug
Also called Survanta
Early surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP)
Standard practiceDrug
Surfactant according to current center practice, only after initiation of mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Early surfactant group | Experimental | Not described Receives: Drug: Early surfactant |
| Standard Practice group | Active comparator | Not described Receives: Drug: Standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for mechanical ventilation following randomization
Measured: Until hospital discharge or 120 days of life
Secondary outcomes (2)
Mean duration of mechanical ventilation
Measured: Until hospital discharge or 120 days of life
Risk morbidities associated with mechanical ventilation and/or early surfactant administration
Measured: Until hospital discharge or 120 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2000 (estimated)
- Study startMay 2000
- Primary completionJul 2002
- Study completionJul 2002
Why it stopped: The trial was stopped after 7 months for lack of recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Collaborators
- National Center for Research Resources (NCRR)
- Investigators
- Edward F. Donovan, MD, Study director, Children's Hospital Medical Center, CincinnatiDavid K. Stevenson, MD, Principal investigator, Stanford UniversityWaldemar A. Carlo, MD, Principal investigator, University of Alabama at BirminghamRichard A. Ehrenkranz, MD, Principal investigator, Yale UniversityBarbara J. Stoll, MD, Principal investigator, Emory UniversityJames A. Lemons, MD, Principal investigator, Indiana UniversityCharles R. Bauer, MD, Principal investigator, University of MiamiLu-Ann Papile, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005774
- Sponsor's protocol ID
- NICHD-NRN-0024
- Other IDs
- U10HD027856, U10HD021364, U10HD034216, U10HD034167, U10HD021397, U10HD027853, U10HD027871, U10HD021415
- Acronym
- Surfactant 2
- Status last verified
- Jun 2015
- First submitted
- 1 Jun 2000
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00005774
- Acronym / sponsor ID
- Surfactant 2 / NICHD-NRN-0024
- Keywords
- NICHD Neonatal Research Network, Pulmonary ventilation, Respiratory distress syndrome, Respiratory insufficiency, Surfactant, pulmonary, Mechanical Ventilation, Survanta
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was stopped after 7 months for lack of recruitment.
- Enrolment
- 61 participants (actual)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- May 2000
- Primary completion
- Jul 2002 (actual)
- Study completion
- Jul 2002 (actual)
- First posted
- 2 Jun 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early surfactant group | Experimental | Drug: Early surfactant |
| Standard Practice group | Active comparator | Drug: Standard practice |
Who may qualify
- Ages
- Up to 12 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Receiving mechanical ventilation
- Air leak
- Pulmonary hemorrhage
- Major congenital anomaly
- Congenital non-bacterial infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early surfactantAlso: SurvantaEarly surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP) | Drug | Early surfactant group |
| Standard practiceSurfactant according to current center practice, only after initiation of mechanical ventilation. | Drug | Standard Practice group |
Primary outcome
Need for mechanical ventilation following randomization
Time frame: Until hospital discharge or 120 days of life
2 secondary outcomes
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
Results and safety
The study was stopped early (reason given: The trial was stopped after 7 months for lack of recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- NICHD Neonatal Research NetworkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward F. Donovan, MD study director
Children's Hospital Medical Center, Cincinnati
David K. Stevenson, MD principal investigator
Stanford University
Waldemar A. Carlo, MD principal investigator
University of Alabama at Birmingham
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Early surfactant and Standard practice in people with Infant, Newborn and Respiratory Distress Syndrome, run by NICHD Neonatal Research Network at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The trial was stopped after 7 months for lack of recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for mechanical ventilation following randomization (time frame: Until hospital discharge or 120 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.