Bronchopulmonary DysplasiaNCT03411018
Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia
An observational study of Bronchopulmonary Dysplasia, run by Manuel Sanchez Luna at 1 site in Spain.
Trial summary
This observational study evaluates the impact of respiratory management modifications implemented in our institution on the intubation rates and the death or Bronchopulmonary Dysplasia (BPD) outcome. Read more about this study
- Who is it for?
- Ages Up to 36 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Mechanical ventilation exposure
- How many people
- 600 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2012to 31 Dec 2017
- 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 Up to 36 weeks
- All sexes
- No healthy volunteers
- Child
Study population: All preterm infant born with less than 32wGA since January 2012 to December 2017 admitted in our NICU.
Who may be able to join
- All preterm Infants born with less than 32wGA admitted in our NICU.
Who cannot join
- Congenital malformations and Known Chromosomal disorders,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Modifications on Respiratory Management of Preterm Infants on the Death or Bronchopulmonary Dysplasia Outcome
This observational study evaluates the impact of respiratory management modifications implemented in our institution on the intubation rates and the death or Bronchopulmonary Dysplasia (BPD) outcome.
Read the detailed description
Less invasive respiratory management has been implemented in most neonatal units as well as lung protective ventilatory strategies when intubation is required in order to minimize ventilator induced lung injury.
In our institution a new ventilatory protocol including less invasive surfactant administration, Synchronized nasal positive pressure ventilation and early rescue High frequency ventilation has been implemented during 2013-14.
Hypothesis: New less invasive and lung protective strategies to prevent lung injury had been effective in reducing intubation rates.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Mechanical ventilation exposure
- Keywords
- lung protective strategies, Less invasive respiratory support, preterm infant
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilation exposureOther
| Study group | Role | What they receive |
|---|---|---|
| Conventional respiratory managed group. | Preterm infants born with less than 32 weeks gestational age (wGA) that entered in the neonatal Intensive care unit (NICU) from January 1 2012 to December 31 2013. These preterm infants were managed according to prior ventilatory protocol: Prophylactic Continuous positive airway pressure (CPAP) in delivery room, early surfactant administration by INSURE technique and volume target mechanical ventilation with rescue high frequency ventilation when needed. Mechanical ventilation exposure will be analyzed Receives: Other: Mechanical ventilation exposure | |
| Less invasive managed group | Preterm Infants born with less than 32wGA that entered the NICU from January 1 2014 to December 31 2017. This infants are managed according to the actual ventilatory protocol. Prophylactic CPAP in delivery room, early surfactant administration by less invasive technique, nasal Synchronized positive pressure ventilation for CPAP failure and early rescue high frequency ventilation with minimally target volume.Mechanical ventilation exposure will be analyzed Receives: Other: Mechanical ventilation exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
BRONCHOPULMONARY DySPLASIA
Diagnosis of moderate-severe bronchopulmonary dysplasia (physiological definition)
Measured: 36 weeks of postmenstrual age.
mortality
death
Measured: before discharge
Secondary outcomes (1)
Mechanical ventilation
requirement of mechanical ventilation
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start1 Jan 2012
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies 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
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manuel Sanchez Luna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manuel Sanchez Luna, Hospital General Universitario Gregorio Marañon
- Investigators
- Cristina Ramos-Navarro, Principal investigator, Gregorio Marañon, Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411018
- Sponsor's protocol ID
- CEIC 84/17
- Status last verified
- Aug 2021
- First submitted
- 19 Jan 2018
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Modifications on Respiratory Management of Preterm Infants on the Death or Bronchopulmonary Dysplasia Outcome
- ClinicalTrials.gov ID
- NCT03411018
- Acronym / sponsor ID
- CEIC 84/17
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- lung protective strategies, Less invasive respiratory support, preterm infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Manuel Sanchez LunaUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 25 Jan 2018 (actual)
- 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 observational study evaluates the impact of respiratory management modifications implemented in our institution on the intubation rates and the death or Bronchopulmonary Dysplasia (BPD) outcome.
Detailed description
Less invasive respiratory management has been implemented in most neonatal units as well as lung protective ventilatory strategies when intubation is required in order to minimize ventilator induced lung injury.
In our institution a new ventilatory protocol including less invasive surfactant administration, Synchronized nasal positive pressure ventilation and early rescue High frequency ventilation has been implemented during 2013-14.
Hypothesis: New less invasive and lung protective strategies to prevent lung injury had been effective in reducing intubation rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional respiratory managed group. | – | Other: Mechanical ventilation exposurePreterm infants born with less than 32 weeks gestational age (wGA) that entered in the neonatal Intensive care unit (NICU) from January 1 2012 to December 31 2013. These preterm infants were managed according to prior ventilatory protocol: Prophylactic Continuous positive airway pressure (CPAP) in delivery room, early surfactant administration by INSURE technique and volume target mechanical ventilation with rescue high frequency ventilation when needed. Mechanical ventilation exposure will be analyzed |
| Less invasive managed group | – | Other: Mechanical ventilation exposurePreterm Infants born with less than 32wGA that entered the NICU from January 1 2014 to December 31 2017. This infants are managed according to the actual ventilatory protocol. Prophylactic CPAP in delivery room, early surfactant administration by less invasive technique, nasal Synchronized positive pressure ventilation for CPAP failure and early rescue high frequency ventilation with minimally target volume.Mechanical ventilation exposure will be analyzed |
Who may qualify
- Ages
- Up to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All preterm infant born with less than 32wGA since January 2012 to December 2017 admitted in our NICU.
Key inclusion criteria (1 listed)
- All preterm Infants born with less than 32wGA admitted in our NICU.
Key exclusion criteria (1 listed)
- Congenital malformations and Known Chromosomal disorders,
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 |
|---|---|---|
| Mechanical ventilation exposure | Other | Conventional respiratory managed group., Less invasive managed group |
Primary outcome
BRONCHOPULMONARY DySPLASIA
Time frame: 36 weeks of postmenstrual age.
Diagnosis of moderate-severe bronchopulmonary dysplasia (physiological definition)
mortality
Time frame: before discharge
death
1 secondary outcome
Mechanical ventilation
Time frame: during hospitalization
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 27 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Bronchopulmonary Dysplasia
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
Cristina Ramos-Navarro principal investigator
Gregorio Marañon, Hospital
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 Bronchopulmonary Dysplasia, run by Manuel Sanchez Luna at 1 site in Spain.
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 1 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 27 Aug 2021. 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 Spain. 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?
BRONCHOPULMONARY DySPLASIA (time frame: 36 weeks of postmenstrual age.). The study lists 2 primary outcomes in all. 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 27 Aug 2021.