Infant, PrematureNCT02748720
Respiratory Dynamics During Birth Stabilization in Preterm Infants Less Than 32+6/7 Weeks Gestation
A study testing RFM (device) Visible in people with Infant, Premature, run by Manuel Sanchez Luna at 1 site in Spain.
Trial summary
Approximately 50% of preterm infants less than 32 weeks require respiratory assistance at the time of transition at birth. For that stabilization during resuscitation is successful, it is essential for proper ventilation. Read more about this study
- Who is it for?
- Ages Up to 1 minute
- Conditions the study is for
- Infant, Premature
- What is being tested?
- RFM (device) Visible
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2014to Mar 2016
- 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 Up to 1 minute
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants less than 32+6/7 weeks gestational age, birth requiring stabilization with VPP or CPAP in the delivery room.
Who cannot join
- Congenital Malformations or Chromosomal Aberrations
- Less Than 22 Weeks
- Birth-weight less Than the Third Percentile for Gestational Age According to Spanish Curve
- Severe Perinatal Asphyxia (Apgar Score of 0-3 More Than 5 Min, Cord Blood ph<7.00)
- reanimation unrecorded with video
- no obtained informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Measurement of Respiratory Dynamics During Birth Stabilization in Preterm Infants Less Than 32+6/7 Weeks Gestation
Approximately 50% of preterm infants less than 32 weeks require respiratory assistance at the time of transition at birth. For that stabilization during resuscitation is successful, it is essential for proper ventilation. This transition is performed with non-invasive respiratory support and administration of positive pressure ventilation to establish adequate functional residual capacity. The problem is that a peak inspiratory fixed during ventilation, and adequate tidal volume is assumed, but usually not measured, unable to correct the peak pressure to optimize ventilation and reduce lung damage. In addition, frequent adverse events may hinder or impair the effectiveness of the ventilation, with the consequent deterioration in the prognosis of the newborn.
Read the detailed description
HYPOTHESIS The ability to visualize the parameters and curves respiratory flow, tidal volume and air pressure by respiratory monitoring with MFR during cardiopulmonary resuscitation in newborns in the delivery room, decreases at least 10% surfactant need in first 72 hours of life.
EVALUATION Data collection will be made prospectively. Investigators will measure the parameters of lung mechanics (tidal volume expiratory airflow (TVe), peak inspiratory pressure (PIP), pressure at the end of exhalation (PEEP), inspiratory time (iT)), in each of inflations administered to preterm with VPP or during the administration of continuous positive airway pressure (CPAP) in spontaneous breathing, in the first 10 minutes after birth, recording the air leakage through the mask and obstructions. Investigators also measure parameters of respiratory status and hemodynamic (FIO 2, oxygen saturation, end tidal CO2, respiratory rate, heart rate), patient monitoring during the implementation of the protocol, blood gases, manipulations of the airway during intervention and the onset of complications.
Patients will be randomize in a Group 1, where these parameters of lung mechanics would be visible and other Group 2, where the parameters of TVe and respiratory flow would not be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). Always, in both groups, current recommendations ventilation measures included in cardiopulmonary resuscitation of newborns of the Spanish Society of Neonatology, based on international recommendations (1-3.5) apply. In turn, the results analyzed in two subgroups between 24 and 27 + 6 weeks gestational age and 28 to 32 + 6 weeks.
- Conditions
- Infant, Premature
- Being tested
- RFM (device) Visible
- Keywords
- Premature, Respiratory Function Monitor
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFM (device) VisibleOther
Will measure the expire tidal volume, end tidal CO2 and peak pressure changes according to clinical improvement and tidal volume
| Study group | Role | What they receive |
|---|---|---|
| RFM Visible | Experimental | Patients will be randomize in other Group 1, where these parameters (from the device Respiratory Function Monitor) of lung mechanics would be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). We adapt or change PIP using visible TVe. Receives: Other: RFM (device) Visible |
| RFM No Visible | No intervention | Patients will be randomize in a Group 2, where the parameters of TVe and respiratory flow would not be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). Always, in both groups, current recommendations ventilation measures included in cardiopulmonary resuscitation of newborns of the Spanish Society of Neonatology, based on international recommendations (1-3.5) apply. In turn, the results analyzed in two subgroups between 24 and 27 + 6 weeks gestational age and 28 to 32 + 6 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce the need for surfactant.
The aim of this study is to investigate whether the use of MFR during resuscitation of preterm (24-32 + 6 weeks) reduce the need for surfactant.
Measured: through study completion, an average of 3 days
Secondary outcomes (6)
Need for intubation and intermittent mechanical ventilation (iMV)
Avoid intubation and Invasive Mechanical Ventilation in the next three days.
Measured: through study completion, an average of 3 days
Incidence of dysplasia bronchopulmonary
Reduce incidence of dysplasia bronchopulmonary
Measured: through study completion, an average of 1 year
CPAP on admission to NICU
Number of newborn with CPAP on admission to NICU
Measured: through study completion, an average of 1 day
Incidence of mortality
Measured: through study completion, an average of 1 year
Measure and get desired tidal volume to optimize resuscitation
Measured: through study completion, an average of 1 year
Number of leaks and obstruction during ventilation mask
The aim of this study is to investigate whether the use of MFR during resuscitation of preterm (24-32 + 6 weeks) reduce number of leaks and obstruction during mask ventilation and improves and set the desired tidal volume to optimize resuscitation.
Measured: through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startOct 2014
- Primary completionNov 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 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
- Gonzalo Zeballos, MD, Principal investigator, Gregorio Marañón Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748720
- Sponsor's protocol ID
- 2014-05
- Status last verified
- Apr 2016
- First submitted
- 4 Apr 2016
- Last updated
- 22 Apr 2016
- 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 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Measurement of Respiratory Dynamics During Birth Stabilization in Preterm Infants Less Than 32+6/7 Weeks Gestation
- ClinicalTrials.gov ID
- NCT02748720
- Acronym / sponsor ID
- 2014-05
- Conditions
- Infant, Premature
- Keywords
- Premature, Respiratory Function Monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Manuel Sanchez LunaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Apr 2016 (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.
Approximately 50% of preterm infants less than 32 weeks require respiratory assistance at the time of transition at birth. For that stabilization during resuscitation is successful, it is essential for proper ventilation. This transition is performed with non-invasive respiratory support and administration of positive pressure ventilation to establish adequate functional residual capacity. The problem is that a peak inspiratory fixed during ventilation, and adequate tidal volume is assumed, but usually not measured, unable to correct the peak pressure to optimize ventilation and reduce lung damage. In addition, frequent adverse events may hinder or impair the effectiveness of the ventilation, with the consequent deterioration in the prognosis of the newborn.
Detailed description
HYPOTHESIS The ability to visualize the parameters and curves respiratory flow, tidal volume and air pressure by respiratory monitoring with MFR during cardiopulmonary resuscitation in newborns in the delivery room, decreases at least 10% surfactant need in first 72 hours of life.
EVALUATION Data collection will be made prospectively. Investigators will measure the parameters of lung mechanics (tidal volume expiratory airflow (TVe), peak inspiratory pressure (PIP), pressure at the end of exhalation (PEEP), inspiratory time (iT)), in each of inflations administered to preterm with VPP or during the administration of continuous positive airway pressure (CPAP) in spontaneous breathing, in the first 10 minutes after birth, recording the air leakage through the mask and obstructions. Investigators also measure parameters of respiratory status and hemodynamic (FIO 2, oxygen saturation, end tidal CO2, respiratory rate, heart rate), patient monitoring during the implementation of the protocol, blood gases, manipulations of the airway during intervention and the onset of complications.
Patients will be randomize in a Group 1, where these parameters of lung mechanics would be visible and other Group 2, where the parameters of TVe and respiratory flow would not be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). Always, in both groups, current recommendations ventilation measures included in cardiopulmonary resuscitation of newborns of the Spanish Society of Neonatology, based on international recommendations (1-3.5) apply. In turn, the results analyzed in two subgroups between 24 and 27 + 6 weeks gestational age and 28 to 32 + 6 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFM Visible | Experimental | Other: RFM (device) VisiblePatients will be randomize in other Group 1, where these parameters (from the device Respiratory Function Monitor) of lung mechanics would be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). We adapt or change PIP using visible TVe. |
| RFM No Visible | No intervention | –Patients will be randomize in a Group 2, where the parameters of TVe and respiratory flow would not be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). Always, in both groups, current recommendations ventilation measures included in cardiopulmonary resuscitation of newborns of the Spanish Society of Neonatology, based on international recommendations (1-3.5) apply. In turn, the results analyzed in two subgroups between 24 and 27 + 6 weeks gestational age and 28 to 32 + 6 weeks |
Who may qualify
- Ages
- Up to 1 minute
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants less than 32+6/7 weeks gestational age, birth requiring stabilization with VPP or CPAP in the delivery room.
Key exclusion criteria (6 listed)
- Congenital Malformations or Chromosomal Aberrations
- Less Than 22 Weeks
- Birth-weight less Than the Third Percentile for Gestational Age According to Spanish Curve
- Severe Perinatal Asphyxia (Apgar Score of 0-3 More Than 5 Min, Cord Blood ph<7.00)
- reanimation unrecorded with video
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 |
|---|---|---|
| RFM (device) VisibleWill measure the expire tidal volume, end tidal CO2 and peak pressure changes according to clinical improvement and tidal volume | Other | RFM Visible |
Primary outcome
Reduce the need for surfactant.
Time frame: through study completion, an average of 3 days
The aim of this study is to investigate whether the use of MFR during resuscitation of preterm (24-32 + 6 weeks) reduce the need for surfactant.
6 secondary outcomes
Need for intubation and intermittent mechanical ventilation (iMV)
Time frame: through study completion, an average of 3 days
Incidence of dysplasia bronchopulmonary
Time frame: through study completion, an average of 1 year
CPAP on admission to NICU
Time frame: through study completion, an average of 1 day
Incidence of mortality
Time frame: through study completion, an average of 1 year
Measure and get desired tidal volume to optimize resuscitation
Time frame: through study completion, an average of 1 year
Number of leaks and obstruction during ventilation mask
Time frame: through study completion, an average of 1 day
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 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Gonzalo Zeballos, MD principal investigator
Gregorio Marañón Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFM (device) Visible in people with Infant, Premature, 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 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 Apr 2016. 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?
Reduce the need for surfactant. (time frame: through study completion, an average of 3 days). 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 22 Apr 2016; AzTrials last refreshed its copy on 29 Oct 2026.