Infant, PrematureNCT02611284
Less Invasive Beractant Administration in Preterm Infants
A study testing LISA and INSURE in people with Infant, Premature, run by Hospital General Universitario Gregorio Marañon.
Trial summary
The aim of this study is to assess the efficacy and feasibility of a new less invasive surfactant administration (LISA) technique with a specific designed cannula for surfactant administration using Beractant replacement in preterm infants <32 weeks of gestation and compare short and long term outcomes with the… Read more about this study
- Who is it for?
- Ages 1 minute to 3 days
- Conditions the study is for
- Infant, Premature
- What is being tested?
- LISA and INSURE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Mar 2015
- 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 1 minute to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants of less than 32 weeks of gestation (WG)breathing spontaneously on nCPAP during the first three days of life that met exogenous surfactant administration criteria (Table l) were eligible to enroll in the study
Who cannot join
- Infants who met intubation criteria (Table 1) at the moment of the surfactant administration were excluded in both groups.
About this study
Official title: Less Invasive Beractant Administration in Preterm Infants: a Pilot Study.
The aim of this study is to assess the efficacy and feasibility of a new less invasive surfactant administration (LISA) technique with a specific designed cannula for surfactant administration using Beractant replacement in preterm infants <32 weeks of gestation and compare short and long term outcomes with the intubation, administration of surfactant and extubation method (INSURE).
This was a single-center, prospective, open-label, non-randomized, controlled study with an experimental cohort of 30 patients treated with LISA and a retrospective control group comprising the 30 most recently treated patients with INSURE. Beractant (4 ml/Kg) was administered as exogenous surfactant in both groups if patients on nasal continuous positive airway pressure (nCPAP) during the first three days of life were needed of more than 30% of fraction of inspired oxygen inspired oxygen fraction (FiO2).
- Conditions
- Infant, Premature
- Being tested
- LISA, INSURE
- Keywords
- Beractant, Feasibility Studies, Infant, Premature, Noninvasive Ventilation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LISAProcedure or surgery
All infants were supported with nCPAP while breathing spontaneously during instillation. A 5Frenchgamma sterilized multi-access catheter specifically designed to deliver surfactants for Neonates was placed 1-2 cm below the vocal cords by direct laryngoscopy without the use of a Magill forceps. Beractant was used as exogenous natural surfactant, (100mg/kg; 4ml/kg) and administered in two aliquots during 1-3 minutes. Positive pressure inflations were given by a mask and bag only if the infant was apneic or bradycardia develops despite the interruption of the procedure. The surfactant administration catheter was removed after surfactant instillation and nCPAP support was maintained. A second dose of surfactant was administered during the first 3 days of life if more than 40% of FiO2 was needed while on nCPAP with at least 6 cm H2O pressure.
INSUREProcedure or surgery
The INSURE technique was performed using Beractant (4ml/kg) after endotracheal intubation. A multi-access catheter for Neonates/Pediatrics designed to deliver surfactants (KimVentTrach Care Technology ®, United Kingdom) was pre-connected to the endotracheal tube and used for surfactant administration without having to disconnect the ventilator. While surfactant was administered all infants were connected to pressure support ventilation modality (PSV) combined with volume guarantee (VG), Dräger ventilator). A tidal volume of 4ml/kg was initially adjusted.
After surfactant administration, all infants were to be extubated, in accordance with our institutional extubation guidelines, if FiO2< 0.35; for a target Oxygen Saturation (SpO2) of >90%, and if a consistent respiratory effort was present. Extubation was supported with nCPAP in all patients.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Cohort (LISA) | Experimental | All preterm infants born at < 32 WG between October 2013 and November 2014 who met inclusion criteria were managed by the new LISA technique. Receives: Procedure: LISA |
| Historical Cohort (INSURE) | Other | The control group was collected from the period immediately before the study's initiation (from Jun 2012 to September 2013). This cohort was comprised of preterm infants of less than 32 WG who met the inclusion criteria. Receives: Procedure: INSURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
% patients >1 h of mechanical ventilation
The percentage of patients that required more than 1 hour of mechanical ventilation during the first three days of age.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
need for intermittent mechanical ventilation (iMV)
need for iMV at any time and its duration
Measured: through study completion, an average of 1 year
second dose of surfactant
the requirement of a second dose of surfactant
Measured: through study completion, an average of 1 year
bradycardia episodes
the number of bradycardia episodes (<100 bpm) needing pressure inflations (PPI) during instillation
Measured: through study completion, an average of 1 year
attempts to catheterize
the number of attempts to catheterize the trachea was recorded
Measured: through study completion, an average of 1 year
surfactant reflux cases
the number of surfactant reflux cases
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startOct 2013
- Primary completionNov 2014
- Study completionMar 2015
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Sanchez Luna, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611284
- Sponsor's protocol ID
- 2015-01
- Status last verified
- Aug 2021
- First submitted
- 16 Nov 2015
- Last updated
- 27 Aug 2021
- Results posted
- No
Publications
Ramos-Navarro C, Sanchez-Luna M, Zeballos-Sarrato S, Gonzalez-Pacheco N. Less invasive beractant administration in preterm infants: a pilot study. Clinics (Sao Paulo). 2016 Mar;71(3):128-34. doi: 10.6061/clinics/2016(03)02.
PubMed 27074172
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
- Less Invasive Beractant Administration in Preterm Infants: a Pilot Study.
- ClinicalTrials.gov ID
- NCT02611284
- Acronym / sponsor ID
- 2015-01
- Conditions
- Infant, Premature
- Keywords
- Beractant, Feasibility Studies, Infant, Premature, Noninvasive Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Nov 2015 (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 aim of this study is to assess the efficacy and feasibility of a new less invasive surfactant administration (LISA) technique with a specific designed cannula for surfactant administration using Beractant replacement in preterm infants <32 weeks of gestation and compare short and long term outcomes with the intubation, administration of surfactant and extubation method (INSURE).
This was a single-center, prospective, open-label, non-randomized, controlled study with an experimental cohort of 30 patients treated with LISA and a retrospective control group comprising the 30 most recently treated patients with INSURE. Beractant (4 ml/Kg) was administered as exogenous surfactant in both groups if patients on nasal continuous positive airway pressure (nCPAP) during the first three days of life were needed of more than 30% of fraction of inspired oxygen inspired oxygen fraction (FiO2).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Cohort (LISA) | Experimental | Procedure: LISAAll preterm infants born at < 32 WG between October 2013 and November 2014 who met inclusion criteria were managed by the new LISA technique. |
| Historical Cohort (INSURE) | Other | Procedure: INSUREThe control group was collected from the period immediately before the study's initiation (from Jun 2012 to September 2013). This cohort was comprised of preterm infants of less than 32 WG who met the inclusion criteria. |
Who may qualify
- Ages
- 1 minute to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants of less than 32 weeks of gestation (WG)breathing spontaneously on nCPAP during the first three days of life that met exogenous surfactant administration criteria (Table l) were eligible to enroll in the study
Key exclusion criteria (1 listed)
- Infants who met intubation criteria (Table 1) at the moment of the surfactant administration were excluded in both groups.
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 |
|---|---|---|
| LISAAll infants were supported with nCPAP while breathing spontaneously during instillation. A 5Frenchgamma sterilized multi-access catheter specifically designed to deliver surfactants for Neonates was placed 1-2 cm below the vocal cords by direct laryngoscopy without the use of a Magill forceps. Beractant was used as exogenous natural surfactant, (100mg/kg; 4ml/kg) and administered in two aliquots during 1-3 minutes. Positive pressure inflations were given by a mask and bag only if the infant was apneic or bradycardia develops despite the interruption of the procedure. The surfactant administration catheter was removed after surfactant instillation and nCPAP support was maintained. A second dose of surfactant was administered during the first 3 days of life if more than 40% of FiO2 was needed while on nCPAP with at least 6 cm H2O pressure. | Procedure or surgery | Treatment Cohort (LISA) |
| INSUREThe INSURE technique was performed using Beractant (4ml/kg) after endotracheal intubation. A multi-access catheter for Neonates/Pediatrics designed to deliver surfactants (KimVentTrach Care Technology ®, United Kingdom) was pre-connected to the endotracheal tube and used for surfactant administration without having to disconnect the ventilator. While surfactant was administered all infants were connected to pressure support ventilation modality (PSV) combined with volume guarantee (VG), Dräger ventilator). A tidal volume of 4ml/kg was initially adjusted. After surfactant administration, all infants were to be extubated, in accordance with our institutional extubation guidelines, if FiO2< 0.35; for a target Oxygen Saturation (SpO2) of >90%, and if a consistent respiratory effort was present. Extubation was supported with nCPAP in all patients. | Procedure or surgery | Historical Cohort (INSURE) |
Primary outcome
% patients >1 h of mechanical ventilation
Time frame: through study completion, an average of 1 year
The percentage of patients that required more than 1 hour of mechanical ventilation during the first three days of age.
5 secondary outcomes
need for intermittent mechanical ventilation (iMV)
Time frame: through study completion, an average of 1 year
second dose of surfactant
Time frame: through study completion, an average of 1 year
bradycardia episodes
Time frame: through study completion, an average of 1 year
attempts to catheterize
Time frame: through study completion, an average of 1 year
surfactant reflux cases
Time frame: through study completion, an average of 1 year
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.
- Derived from this study: PubMed 27074172Ramos-Navarro C, Sanchez-Luna M, Zeballos-Sarrato S, Gonzalez-Pacheco N. Less invasive beractant administration in preterm infants: a pilot study. Clinics (Sao Paulo). 2016 Mar;71(3):128-34. doi: 10.6061/clinics/2016(03)02.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing LISA and INSURE in people with Infant, Premature, run by Hospital General Universitario Gregorio Marañon.
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.
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?
% patients >1 h of mechanical ventilation (time frame: through study completion, an average of 1 year). 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 NCT02611284, 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 27 Aug 2021.