Respiratory Distress SyndromePhase 4NCT05714865
Implementing LISA Surfactant in Nigeria
A Phase 4 study testing Surfactant in people with Respiratory Distress Syndrome and Neonatal Death, run by Indiana University at 6 sites in Nigeria.
Trial summary
Implement surfactant (BLES®) replacement therapy using the Less Invasive Surfactant Administration technique in six tertiary institutions in Nigeria and evaluate its impact on 72-hour neonatal mortality in premature infants born less than 2000 grams at birth. Read more about this study
- Who is it for?
- Ages 1 hour to 2 days
- Conditions the study is for
- Respiratory Distress Syndrome, Neonatal Death
- What is being tested?
- Surfactant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 6 sitesNigeria
- Study dates
- 25 Jun 2023to 30 Mar 2025
- Phase
- Phase 4
- 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 hour to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns with birth weight between 500-2000 grams (determined by birth weight or admission weight if birth weight is unavailable).
- ≤48 Hours old at recruitment.
- Spontaneously breathing but have clinical signs of respiratory distress (defined by Anderson Silverman Score (ASS) ≥4 (range 0-10)) and on CPAP.
- Admitted to the neonatal/newborn units (or special care nurseries).
Who cannot join
- Any newborn intubated before admission to the neonatal/newborn units.
- Any newborn infants with a significant congenital abnormality
- Any preterm infant considered nonviable by the managing clinician.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Nigeria6 sites
Federal Medical Center Asaba
Asaba, Delta, 11111
University of Benin Teaching Hospital
Benin City, Edo, 11111
University of Nigeria Teaching Hospital
Enugu, 11111
National Hospital Abuja
Garki, FCT Abuja, 11111
Lagos University Teaching Hospital.
Idi-Araba, Lagos, 11111
Aminu Kano Teaching Hospital
Zaria, Kano State, 11111
About this study
Official title: Less Invasive Surfactant Administration in Nigeria
Implement surfactant (BLES®) replacement therapy using the Less Invasive Surfactant Administration technique in six tertiary institutions in Nigeria and evaluate its impact on 72-hour neonatal mortality in premature infants born less than 2000 grams at birth.
Read the detailed description
Background: In low- and middle-income countries (LMICs), respiratory distress syndrome (RDS) accounts for ~45% of all in-hospital neonatal mortality. Surfactant use is limited in LMICs, in part, due to the high cost, the lack of skill to perform laryngoscopy and tracheal intubation, and perhaps a perception that surfactant administration and mechanical ventilation must occur together. In LMICs, continuous positive airway pressure (CPAP) is often the highest mode of respiratory support available, and CPAP failure invariably means death. If Less Invasive Surfactant Administration (LISA) can reduce CPAP failure, as shown in high-income settings, it potentially can reduce prematurity-related neonatal mortality in LMICs. There are, however, no studies on how to safely implement LISA in LMICs. The LISA procedure is novel in LMICs; the procedure is not without risk (severe and minor), laryngoscopy is a difficult skill to acquire, master, and maintain, and the resource limitations in LMICs need consideration while implementing LISA.
Hypothesis: Compared to a historical control, introducing non-invasive surfactant administration through the less invasive surfactant administration (LISA) techniques will result in a relative risk reduction of all-cause 72-hour in-hospital mortality by at least 20%.
PICO Outline:
Population: Preterm infants </= 2 kg with respiratory distress defined by a Downes Respiratory Distress Score of >4, who are spontaneously breathing, and on CPAP.
Intervention: Surfactant administered through the less invasive surfactant administration (LISA), technique.
Comparator: A historical control of preterm babies </= 2 kg with respiratory distress defined by a Downes Respiratory Distress Score of >4, who are spontaneously breathing, and on CPAP.
Outcome measures:
Primary Outcome: 72-hour all-cause in-hospital mortality.
Secondary outcomes
- All-cause in-hospital mortality
- Change in respiratory distress score, pre- to -post interventions.
- Conditions
- Respiratory Distress Syndrome, Neonatal Death
- Being tested
- Surfactant
- Medical subject headings
- Respiratory Distress Syndrome, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurfactantDrug
Also called BLES® Surfactant, BLEScath™, Less Invasive Surfactant Administration
Laryngoscopy is performed, and BLES® surfactant is administered through BLEScath™ (a thin catheter) into the trachea to a spontaneously breathing preterm infant with respiratory distress syndrome who is being managed on CPAP
| Study group | Role | What they receive |
|---|---|---|
| LISA Arm | Experimental | Eligible subjects who have respiratory distress syndrome (Anderson Silverman Score >4) managed on continuous positive airway pressure (CPAP) will receive surfactant via a thin catheter while on CPAP. Receives: Drug: Surfactant |
What is being measured
The primary outcome is the main question the study is designed to answer.
72-hour mortality
All cause mortality with 72-hours of life
Measured: 72 hours of life
Secondary outcomes (2)
In-hospital mortality
All cause mortality during hospitalization
Measured: Through hospitalization, an average of 1 day to 10 weeks.
Difference in RDS score before and after the procedure.
Change in Anderson Silverman RDS Score before and after intervention (range: 0 to 10)
Measured: 6 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start25 Jun 2023
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort
- Masking
- None (open label)
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- BLES Biochemicals Inc.
- Responsible party
- Principal investigator, Osayame Ekhaguere, Indiana University
- Investigators
- Osayame A Ekhaguere, MBBS, MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714865
- Sponsor's protocol ID
- NHREC/01/01/2007-12/10/2022
- Status last verified
- Aug 2025
- First submitted
- 28 Dec 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: On request and approval from local principal investigators and ethical approval committee
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Less Invasive Surfactant Administration in Nigeria
- ClinicalTrials.gov ID
- NCT05714865
- Acronym / sponsor ID
- NHREC/01/01/2007-12/10/2022
- Conditions
- Respiratory Distress Syndrome, Neonatal Death
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- BLES Biochemicals Inc.
- Study start
- 25 Jun 2023 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 6 Feb 2023 (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.
Implement surfactant (BLES®) replacement therapy using the Less Invasive Surfactant Administration technique in six tertiary institutions in Nigeria and evaluate its impact on 72-hour neonatal mortality in premature infants born less than 2000 grams at birth.
Detailed description
Background: In low- and middle-income countries (LMICs), respiratory distress syndrome (RDS) accounts for ~45% of all in-hospital neonatal mortality. Surfactant use is limited in LMICs, in part, due to the high cost, the lack of skill to perform laryngoscopy and tracheal intubation, and perhaps a perception that surfactant administration and mechanical ventilation must occur together. In LMICs, continuous positive airway pressure (CPAP) is often the highest mode of respiratory support available, and CPAP failure invariably means death. If Less Invasive Surfactant Administration (LISA) can reduce CPAP failure, as shown in high-income settings, it potentially can reduce prematurity-related neonatal mortality in LMICs. There are, however, no studies on how to safely implement LISA in LMICs. The LISA procedure is novel in LMICs; the procedure is not without risk (severe and minor), laryngoscopy is a difficult skill to acquire, master, and maintain, and the resource limitations in LMICs need consideration while implementing LISA.
Hypothesis: Compared to a historical control, introducing non-invasive surfactant administration through the less invasive surfactant administration (LISA) techniques will result in a relative risk reduction of all-cause 72-hour in-hospital mortality by at least 20%.
PICO Outline:
Population: Preterm infants </= 2 kg with respiratory distress defined by a Downes Respiratory Distress Score of >4, who are spontaneously breathing, and on CPAP.
Intervention: Surfactant administered through the less invasive surfactant administration (LISA), technique.
Comparator: A historical control of preterm babies </= 2 kg with respiratory distress defined by a Downes Respiratory Distress Score of >4, who are spontaneously breathing, and on CPAP.
Outcome measures:
Primary Outcome: 72-hour all-cause in-hospital mortality.
Secondary outcomes
- All-cause in-hospital mortality
- Change in respiratory distress score, pre- to -post interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort
| Arm | Type | Receives |
|---|---|---|
| LISA Arm | Experimental | Drug: SurfactantEligible subjects who have respiratory distress syndrome (Anderson Silverman Score >4) managed on continuous positive airway pressure (CPAP) will receive surfactant via a thin catheter while on CPAP. |
Who may qualify
- Ages
- 1 hour to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Newborns with birth weight between 500-2000 grams (determined by birth weight or admission weight if birth weight is unavailable).
- ≤48 Hours old at recruitment.
- Spontaneously breathing but have clinical signs of respiratory distress (defined by Anderson Silverman Score (ASS) ≥4 (range 0-10)) and on CPAP.
- Admitted to the neonatal/newborn units (or special care nurseries).
Key exclusion criteria (3 listed)
- Any newborn intubated before admission to the neonatal/newborn units.
- Any newborn infants with a significant congenital abnormality
- Any preterm infant considered nonviable by the managing clinician.
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 |
|---|---|---|
| SurfactantAlso: BLES® Surfactant, BLEScath™, Less Invasive Surfactant AdministrationLaryngoscopy is performed, and BLES® surfactant is administered through BLEScath™ (a thin catheter) into the trachea to a spontaneously breathing preterm infant with respiratory distress syndrome who is being managed on CPAP | Drug | LISA Arm |
Primary outcome
72-hour mortality
Time frame: 72 hours of life
All cause mortality with 72-hours of life
2 secondary outcomes
In-hospital mortality
Time frame: Through hospitalization, an average of 1 day to 10 weeks.
Difference in RDS score before and after the procedure.
Time frame: 6 hours post procedure
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 24 Aug 2025.
- Individual participant dataSharing planned: No. On request and approval from local principal investigators and ethical approval committee
Related trials for Respiratory Distress Syndrome
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Not yet recruitingPhase 2
Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults
Acute Respiratory Distress Syndrome, ARDS
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
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.
Osayame A Ekhaguere, MBBS, MPH principal investigator
Indiana University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Surfactant in people with Respiratory Distress Syndrome and Neonatal Death, run by Indiana University at 6 sites in Nigeria.
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 4 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 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Nigeria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
72-hour mortality (time frame: 72 hours of life). 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 24 Aug 2025.