Respiratory Distress SyndromeNCT00165074
Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With Respiratory Decompensation
A study testing Infasurf (drug) in people with Respiratory Distress Syndrome, run by Children's Hospital of Philadelphia.
Trial summary
The purpose of the study is to determine whether additional surfactant(Infasurf) doses at 7 to 10 days of life time will improve lung function in premature infants, allowing a decrease in required oxygen concentration and ventilator settings. Read more about this study
- Who is it for?
- Ages 7 to 10 days
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Infasurf (drug)
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Jun 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 1250 gm birthweight
- Day 5-21 of life
- Intubated and mechanically ventilated, with respiratory decompensation, defined as the majority of daily severity scores (calculated every 6 hr from average of respiratory settings over 3-4 hour period) rising from baseline < 1.8, to > 3.5, sustained for >24hr. Note: Prior surfactant therapy at birth is neither an inclusion nor exclusion criterion.
Who cannot join
- Serious congenital malformations
- Life expectancy < 7 days from enrollment
- Patent ductus arteriosus at time of decompensation
- Pulmonary hemorrhage as cause of respiratory decompensation
- Active air leak syndrome at time of decompensation
- Postnatal steroid therapy for lung disease
About this study
Official title: Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With
The purpose of the study is to determine whether additional surfactant(Infasurf) doses at 7 to 10 days of life time will improve lung function in premature infants, allowing a decrease in required oxygen concentration and ventilator settings.
Read the detailed description
Pulmonary surfactant is required for normal lung function. Preliminary data from previous trials suggest that more than half of chronically ventilated premature infants, greater than 1 week of age, have at least one episode of surfactant dysfunction, as measured in vitro, associated with a low surfactant protein B content. We propose to enroll premature infants less than 1250 gm birthweight, between days 5 and 21 of life who are intubated, mechanically ventilated, with a respiratory decompensation, defined as a severity score (mean airway pressure x FIO2) rising from a baseline of < 1.8 to > 3.5, sustained for > 24 hours. Infants will receive two doses of Infasurf surfactant, 12-24 hours apart, at the standard dose of 3 ml/kg. Primary outcome is the change in respiratory severity score at 72 hours post surfactant treatment compared to pre-treatment. Sample size is 31 infants, study duration is 3 years, and recruitment of study patients will occur at the Hospital of the University of Pennsylvania, and Women and Children's Hospital of Buffalo.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Infasurf (drug)
- Keywords
- Prematurity, Lung Disease, Hyaline Membrane, Surfactant
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infasurf (drug)Drug
Also called Infasurf (calfactant, manufactured for Forest Pharmaceuticals, Inc. St. Louis, MO, by ONY Inc., Amherst, NY
Infasurf 3 cc/kg instilled via endotracheal tube q 12-24 hours x 2 doses
What is being measured
The primary outcome is the main question the study is designed to answer.
We hypothesize that at least 25% of treated infants will have a 50% or greater reduction in respiratory severity score at 72 hours compared to pre-treat
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJun 2003
- Study completionJun 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
- 11 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
- 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
- NCT00165074
- Sponsor's protocol ID
- 2002-9-2968
- Status last verified
- Nov 2007
- First submitted
- 9 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 Therapy For Preterm Neonates 5-21 Days Old With
- ClinicalTrials.gov ID
- NCT00165074
- Acronym / sponsor ID
- 2002-9-2968
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Prematurity, Lung Disease, Hyaline Membrane, Surfactant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Women & Children's Hospital of Buffalo
- Study start
- Jun 2003
- Study completion
- Jun 2007 (actual)
- First posted
- 14 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.
The purpose of the study is to determine whether additional surfactant(Infasurf) doses at 7 to 10 days of life time will improve lung function in premature infants, allowing a decrease in required oxygen concentration and ventilator settings.
Detailed description
Pulmonary surfactant is required for normal lung function. Preliminary data from previous trials suggest that more than half of chronically ventilated premature infants, greater than 1 week of age, have at least one episode of surfactant dysfunction, as measured in vitro, associated with a low surfactant protein B content. We propose to enroll premature infants less than 1250 gm birthweight, between days 5 and 21 of life who are intubated, mechanically ventilated, with a respiratory decompensation, defined as a severity score (mean airway pressure x FIO2) rising from a baseline of < 1.8 to > 3.5, sustained for > 24 hours. Infants will receive two doses of Infasurf surfactant, 12-24 hours apart, at the standard dose of 3 ml/kg. Primary outcome is the change in respiratory severity score at 72 hours post surfactant treatment compared to pre-treatment. Sample size is 31 infants, study duration is 3 years, and recruitment of study patients will occur at the Hospital of the University of Pennsylvania, and Women and Children's Hospital of Buffalo.
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 1250 gm birthweight
- Day 5-21 of life
- Intubated and mechanically ventilated, with respiratory decompensation, defined as the majority of daily severity scores (calculated every 6 hr from average of respiratory settings over 3-4 hour period) rising from baseline < 1.8, to > 3.5, sustained for >24hr. Note: Prior surfactant therapy at birth is neither an inclusion nor exclusion criterion.
Key exclusion criteria (6 listed)
- Serious congenital malformations
- Life expectancy < 7 days from enrollment
- Patent ductus arteriosus at time of decompensation
- Pulmonary hemorrhage as cause of respiratory decompensation
- Active air leak syndrome at time of decompensation
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 |
|---|---|---|
| Infasurf (drug)Also: Infasurf (calfactant, manufactured for Forest Pharmaceuticals, Inc. St. Louis, MO, by ONY Inc., Amherst, NYInfasurf 3 cc/kg instilled via endotracheal tube q 12-24 hours x 2 doses | Drug | – |
Primary outcome
We hypothesize that at least 25% of treated infants will have a 50% or greater reduction in respiratory severity score at 72 hours compared to pre-treat
Time frame: 72 hours
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 (drug) in people with Respiratory Distress Syndrome, 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 6 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?
We hypothesize that at least 25% of treated infants will have a 50% or greater reduction in respiratory severity score at 72 hours compared to pre-treat (time frame: 72 hours). 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 NCT00165074, 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.