Respiratory Distress SyndromeNCT00208039
Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates
A study testing Infasurf in people with Respiratory Distress Syndrome and Bronchopulmonary Dysplasia, run by Children's Hospital of Philadelphia.
Trial summary
A research study that will evaluate if giving surfactant medication to premature babies weighing < 1250 gm at birth during the second and third weeks of life will help their lungs. We are enrolling those premature babies who continue to require the breathing tube and the mechanical ventilator at days 7-10 of life. Read more about this study
- Who is it for?
- Ages 7 to 10 days
- Conditions the study is for
- Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
- What is being tested?
- Infasurf
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Nov 2007
- Phase
- Interventional
- 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 7 to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Less than or equal to1250 gm birthweight
- Day 7-10 of life
- Intubated and mechanically ventilated at day 7-10 of life
Who cannot join
- Infants intubated solely for apnea
- Serious congenital malformations
- Life expectancy < 7 days from enrollment
- Pulmonary hemorrhage at time of enrollment
- Active air leak syndrome at time of enrollment
- Bilateral grade IV intracranial hemorrhage
- Postnatal systemic steroid therapy for lung disease
- Note: Prior surfactant therapy at birth is neither an inclusion nor exclusion criterion.
About this study
Official title: Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates Less Than or Equal to 1250 gm Birthweight Ver 4.0
A research study that will evaluate if giving surfactant medication to premature babies weighing < 1250 gm at birth during the second and third weeks of life will help their lungs. We are enrolling those premature babies who continue to require the breathing tube and the mechanical ventilator at days 7-10 of life.
Read the detailed description
Pulmonary surfactant is required for normal lung function. Data from a previous study suggest that as many as 75% of chronically ventilated extremely low birthweight premature infants have at least one episode of surfactant dysfunction beyond the first week of life, as measured in vitro, associated with a low surfactant protein B content. Furthermore, episodes of surfactant dysfunction are significantly associated with clinically significant respiratory decompensations. We hypothesize that booster doses of surfactant given during the second and third week of life to extremely low birth weight premature infants requiring persistent intubation and mechanical ventilation will improve their respiratory status during the first 28 days of life. We propose to enroll premature infants < 1250 gm birthweight, between days 7 and 10 of life who are intubated, and mechanically ventilated. Infants requiring persistent intubation and mechanical ventilation for respiratory support at 7-10 days of life will receive a total of 3 doses of Infasurf surfactant, 3 days apart, at the standard dose of 3 ml/kg. Primary outcome is the change in area under the respiratory severity score curve between days 7 and 28 of life. Total sample size is 88 infants, study duration is 36 months, and recruitment of study patients will occur at The Hospital of the University of Pennsylvania, in Philadelphia PA, Women and Children's Hospital in Buffalo, St. Louis Children's Hospital in St. Louis MO, Mercy Children's Hospital in Kansas City, Oakland Children's and Alta Bates Medical Center in Berkeley, CA and Long Island Jewish Medical Center, NY.
- Being tested
- Infasurf
- Keywords
- Prematurity, Lung Disease, Hyaline Membrane, Surfactant
- Medical subject headings
- Respiratory Distress Syndrome, Bronchopulmonary Dysplasia, Premature Birth, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfasurfDrug
Also called Infasurf (calfactant, manufactured for INOTherapeutics, Clinton NJ by ONY Inc., Amherst, NY)
Infasurf 3 cc/kg instilled via endotracheal tube, repeated 3 and 7 days later if infant stable and continues to meet criteria
What is being measured
The primary outcome is the main question the study is designed to answer.
Surfactant therapy will decrease the mean area under the curve(of the plots of daily respiratory severity scores between days 7 and 28 of life), by 33% from historic controls.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 2004
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Women & Children's Hospital of Buffalo, Children's Mercy Hospital Kansas City, St. Louis Children's Hospital, UCSF Benioff Children's Hospital Oakland, Alta Bates Summit Medical Center, Long Island Jewish Medical Center
- Investigators
- Michael Posencheg, MD, Principal investigator, University of Pennsylvania/Children's Hospital of PhiladelphiaRoberta A Ballard, MD, Principal investigator, University of California, San Francisco Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208039
- Sponsor's protocol ID
- 2004-9-3983
- Status last verified
- Nov 2007
- First submitted
- 13 Sep 2005
- Last updated
- 22 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Merrill JD, Ballard RA, Cnaan A, Hibbs AM, Godinez RI, Godinez MH, Truog WE, Ballard PL. Dysfunction of pulmonary surfactant in chronically ventilated premature infants. Pediatr Res. 2004 Dec;56(6):918-26. doi: 10.1203/01.PDR.0000145565.45490.D9. Epub 2004 Oct 20.
PubMed 15496605
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates Less Than or Equal to 1250 gm Birthweight Ver 4.0
- ClinicalTrials.gov ID
- NCT00208039
- Acronym / sponsor ID
- 2004-9-3983
- Keywords
- Prematurity, Lung Disease, Hyaline Membrane, Surfactant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Women & Children's Hospital of Buffalo, Children's Mercy Hospital Kansas City, St. Louis Children's Hospital, UCSF Benioff Children's Hospital Oakland, Alta Bates Summit Medical Center, Long Island Jewish Medical Center
- Study start
- Sep 2004
- Study completion
- Nov 2007 (actual)
- First posted
- 21 Sep 2005 (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.
A research study that will evaluate if giving surfactant medication to premature babies weighing < 1250 gm at birth during the second and third weeks of life will help their lungs. We are enrolling those premature babies who continue to require the breathing tube and the mechanical ventilator at days 7-10 of life.
Detailed description
Pulmonary surfactant is required for normal lung function. Data from a previous study suggest that as many as 75% of chronically ventilated extremely low birthweight premature infants have at least one episode of surfactant dysfunction beyond the first week of life, as measured in vitro, associated with a low surfactant protein B content. Furthermore, episodes of surfactant dysfunction are significantly associated with clinically significant respiratory decompensations. We hypothesize that booster doses of surfactant given during the second and third week of life to extremely low birth weight premature infants requiring persistent intubation and mechanical ventilation will improve their respiratory status during the first 28 days of life. We propose to enroll premature infants < 1250 gm birthweight, between days 7 and 10 of life who are intubated, and mechanically ventilated. Infants requiring persistent intubation and mechanical ventilation for respiratory support at 7-10 days of life will receive a total of 3 doses of Infasurf surfactant, 3 days apart, at the standard dose of 3 ml/kg. Primary outcome is the change in area under the respiratory severity score curve between days 7 and 28 of life. Total sample size is 88 infants, study duration is 36 months, and recruitment of study patients will occur at The Hospital of the University of Pennsylvania, in Philadelphia PA, Women and Children's Hospital in Buffalo, St. Louis Children's Hospital in St. Louis MO, Mercy Children's Hospital in Kansas City, Oakland Children's and Alta Bates Medical Center in Berkeley, CA and Long Island Jewish Medical Center, NY.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 7 to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Less than or equal to1250 gm birthweight
- Day 7-10 of life
- Intubated and mechanically ventilated at day 7-10 of life
Key exclusion criteria (8 listed)
- Infants intubated solely for apnea
- Serious congenital malformations
- Life expectancy < 7 days from enrollment
- Pulmonary hemorrhage at time of enrollment
- Active air leak syndrome at time of enrollment
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 |
|---|---|---|
| InfasurfAlso: Infasurf (calfactant, manufactured for INOTherapeutics, Clinton NJ by ONY Inc., Amherst, NY)Infasurf 3 cc/kg instilled via endotracheal tube, repeated 3 and 7 days later if infant stable and continues to meet criteria | Drug | – |
Primary outcome
Surfactant therapy will decrease the mean area under the curve(of the plots of daily respiratory severity scores between days 7 and 28 of life), by 33% from historic controls.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2007.
- Background: PubMed 15496605Merrill JD, Ballard RA, Cnaan A, Hibbs AM, Godinez RI, Godinez MH, Truog WE, Ballard PL. Dysfunction of pulmonary surfactant in chronically ventilated premature infants. Pediatr Res. 2004 Dec;56(6):918-26. doi: 10.1203/01.PDR.0000145565.45490.D9. Epub 2004 Oct 20.
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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.
Michael Posencheg, MD principal investigator
University of Pennsylvania/Children's Hospital of Philadelphia
Roberta A Ballard, MD principal investigator
University of California, San Francisco Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Infasurf in people with Respiratory Distress Syndrome and Bronchopulmonary Dysplasia, run by Children's Hospital of Philadelphia.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 22 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Surfactant therapy will decrease the mean area under the curve(of the plots of daily respiratory severity scores between days 7 and 28 of life), by 33% from historic controls. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00208039, which also lists 1 linked publication.
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 22 Nov 2007.