Preterm BirthNCT01601886
Delivery Room Practice Change Following the Initiation of the NICHD SUPPORT Trial
An observational study of Preterm Birth, run by Luc Brion at 1 site in United States.
Trial summary
This study was designed to analyze whether initiation of the NICHD Neonatal Research Network SUPPORT trial was followed by a change in frequency of endotracheal intubation the delivery room in non-participants and whether these changes were associated with changes in management and outcomes. Read more about this study
- Who is it for?
- Ages 24 to 35 weeks
- Conditions the study is for
- Preterm Birth
- How many people
- 3,843 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Apr 2012
- Phase
- Observational
- 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 24 to 35 weeks
- All sexes
- No healthy volunteers
- Child
Study population: All babies born at Parkland Memorial Hospital with gestational age at least 24 weeks and less than 35 weeks between 01/2003 and 06/2010
Who may be able to join
- All babies born at Parkland Memorial Hospital with gestational age at least 24 weeks and less than 35 weeks between 01/2003 and 06/2010
Who cannot join
- Infants receiving comfort care
- Those with major congenital anomalies
- Those enrolled in the SUPPORT trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern
Dallas, Texas, 75390-9063
About this study
This study was designed to analyze whether initiation of the NICHD Neonatal Research Network SUPPORT trial was followed by a change in frequency of endotracheal intubation the delivery room in non-participants and whether these changes were associated with changes in management and outcomes.
The investigators hypothesized that the investigators would observe following the initiation of the SUPPORT trial a 33% reduction in the rate of intubation in the delivery room among non-participants preterm infants at Parkland Memorial Hospital.
- Conditions
- Preterm Birth
- Keywords
- Intubation, Intratracheal, Continuous Positive Airway Pressure, Historical Cohort Studies, Clinical Trial
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Before SUPPORT | 01/03-06/05 | |
| During SUPPORT recruitment | 07/05-02/09 | |
| After SUPPORT | 03/09-06/10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal intubation in the delivery room
Frequency of endotracheal intubation in the delivery room
Measured: In the delivery room (1 day)
Secondary outcomes (12)
Continuous positive airway pressure in the delivery room
Frequency of continuous positive airway pressure in the delivery room
Measured: In the delivery room (1 day)
Endotracheal intubation in the first four hours after admission
Frequency of endotracheal intubation in the first fours after admission to the neonatal intensive care unit
Measured: First four hours after admission
Endotracheal intubation until four hours after admission
Frequency of endotracheal intubation between birth and four hours after admission in the neonatal intensive care unit
Measured: Between birth and 4 hours after admission
Admninistration of surfactant
Frequency of admninistration of surfactant any time between birth and 2 days of age
Measured: Any time between birth and 2 days of age
Pneumothorax
Pneumothorax any time before discharge or transfer or 12 months of age (whichever comes first)
Measured: Any time before discharge or transfer or 12 months of age (whichever comes first)
Bronchopulmonary dysplasia
Chronic changes on chest radiograph and oxygen requirement (fractional inspiratory concentration of oxygen greater than 0.21) for at least 28 days
Measured: 28 days
Necrotizing enterocolitis
Necrotizing enterocolitis (at least stage II, modified Bell's classification) any time before discharge or transfer or 12 months of age (whichever comes first)
Measured: Any time before discharge or transfer or 12 months of age (whichever comes first)
Duration of mechanical ventilation
Duration of invasive mechanical ventilation until discharge or transfer or or 12 months of age (whichever comes first)
Measured: Until discharge or transfer or 12 months of age (whichever comes first)
Maximum oxygen concentration
Maximum inspiratory oxygen concentration until discharge or transfer or 12 months of age (whichever comes first)
Measured: Until discharge or transfer or 12 months of age (whichever comes first)
Severe retinopathy of prematurity
Severe retinopathy of prematurity (at least stage III, international classification) until discharge or transfer or 12 months of age (whichever comes first)
Measured: Until discharge or transfer or 12 months of age (whichever comes first)
Mortality
Mortality until discharge or transfer or 12 months of age (whichever comes first)
Measured: Until discharge or transfer or 12 months of age (whichever comes first)
Severe brain lesion on imaging
Cystic periventricular leukomalacia or grade III or IV intraventricular/ periventricular hemorrhage detected by ultrasonogram any time before discharge or transfer or 12 months of age (whichever comes first)
Measured: Any time before discharge or transfer or 12 months of age (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startApr 2008
- Primary completionNov 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,843 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luc Brion
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center
- Responsible party
- Sponsor-investigator, Luc Brion, University of Texas Southwestern Medical Center
- Investigators
- Luc P Brion, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601886
- Sponsor's protocol ID
- STU 092010-201
- Other IDs
- Velos 12121
- Status last verified
- May 2012
- First submitted
- 15 May 2012
- Last updated
- 18 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery Room Practice Change Following the Initiation of the NICHD SUPPORT Trial
- ClinicalTrials.gov ID
- NCT01601886
- Acronym / sponsor ID
- STU 092010-201
- Conditions
- Preterm Birth
- Keywords
- Intubation, Intratracheal, Continuous Positive Airway Pressure, Historical Cohort Studies, Clinical Trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,843 participants (actual)
- Lead sponsor
- Luc BrionUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center
- Study start
- Apr 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 May 2012 (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.
This study was designed to analyze whether initiation of the NICHD Neonatal Research Network SUPPORT trial was followed by a change in frequency of endotracheal intubation the delivery room in non-participants and whether these changes were associated with changes in management and outcomes.
The investigators hypothesized that the investigators would observe following the initiation of the SUPPORT trial a 33% reduction in the rate of intubation in the delivery room among non-participants preterm infants at Parkland Memorial Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Before SUPPORT | – | –01/03-06/05 |
| During SUPPORT recruitment | – | –07/05-02/09 |
| After SUPPORT | – | –03/09-06/10 |
Who may qualify
- Ages
- 24 to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All babies born at Parkland Memorial Hospital with gestational age at least 24 weeks and less than 35 weeks between 01/2003 and 06/2010
Key inclusion criteria (1 listed)
- All babies born at Parkland Memorial Hospital with gestational age at least 24 weeks and less than 35 weeks between 01/2003 and 06/2010
Key exclusion criteria (3 listed)
- Infants receiving comfort care
- Those with major congenital anomalies
- Those enrolled in the SUPPORT trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endotracheal intubation in the delivery room
Time frame: In the delivery room (1 day)
Frequency of endotracheal intubation in the delivery room
12 secondary outcomes
Continuous positive airway pressure in the delivery room
Time frame: In the delivery room (1 day)
Endotracheal intubation in the first four hours after admission
Time frame: First four hours after admission
Endotracheal intubation until four hours after admission
Time frame: Between birth and 4 hours after admission
Admninistration of surfactant
Time frame: Any time between birth and 2 days of age
Pneumothorax
Time frame: Any time before discharge or transfer or 12 months of age (whichever comes first)
Bronchopulmonary dysplasia
Time frame: 28 days
Necrotizing enterocolitis
Time frame: Any time before discharge or transfer or 12 months of age (whichever comes first)
Duration of mechanical ventilation
Time frame: Until discharge or transfer or 12 months of age (whichever comes first)
Maximum oxygen concentration
Time frame: Until discharge or transfer or 12 months of age (whichever comes first)
Severe retinopathy of prematurity
Time frame: Until discharge or transfer or 12 months of age (whichever comes first)
Mortality
Time frame: Until discharge or transfer or 12 months of age (whichever comes first)
Severe brain lesion on imaging
Time frame: Any time before discharge or transfer or 12 months of age (whichever comes first)
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 18 May 2012.
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Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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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.
Luc P Brion, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by Luc Brion at 1 site 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 1 inclusion and 3 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 18 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Endotracheal intubation in the delivery room (time frame: In the delivery room (1 day)). 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 18 May 2012.