Using LISA Surfactant to Reduce Neonatal Deaths in Nigeria
Less Invasive Surfactant Administration in Nigeria
This study is testing a new way to give surfactant treatment to help premature babies with breathing problems in Nigeria, to see if it can lower the number of newborns who die within 72 hours.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 1 Hour to 2 Days |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 6 sites (Asaba, Delta State and 5 other locations) |
| Trial ID | NCT05714865 on ClinicalTrials.gov |
What this trial studies
This study aims to implement surfactant replacement therapy using the Less Invasive Surfactant Administration (LISA) technique in six tertiary institutions across Nigeria. It focuses on evaluating the impact of this intervention on 72-hour neonatal mortality rates in premature infants weighing less than 2000 grams who are experiencing respiratory distress. The study addresses the challenges of surfactant use in low- and middle-income countries, where traditional methods may not be feasible due to resource limitations and skill deficits. By introducing LISA, the researchers hope to reduce the high rates of neonatal mortality associated with respiratory distress syndrome in these settings.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns weighing between 500-2000 grams, less than 48 hours old, who are spontaneously breathing and showing signs of respiratory distress.
Not a fit: Patients who have been intubated prior to admission or have significant congenital abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower neonatal mortality rates in premature infants suffering from respiratory distress in low-resource settings.
How similar studies have performed: While LISA has shown success in high-income settings, this study represents a novel approach to implementing it in low- and middle-income countries, where such techniques have not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Where this trial is running
Asaba, Delta State and 5 other locations
- Federal Medical Center Asaba — Asaba, Delta State, Nigeria (Recruiting)
- University of Benin Teaching Hospital — Benin City, Edo State, Nigeria (Recruiting)
- National Hospital Abuja — Garki, FCT Abuja, Nigeria (Not_yet_recruiting)
- Aminu Kano Teaching Hospital — Zaria, Kano, Nigeria (Not_yet_recruiting)
- Lagos University Teaching Hospital. — Idi-Araba, Lagos, Nigeria (Not_yet_recruiting)
- University of Nigeria Teaching Hospital — Enugu, Nigeria (Recruiting)
Study contacts
- Principal investigator: Osayame A Ekhaguere, MBBS, MPH — Indiana University School of Medicine
- Study coordinator: Osayame A Ekhaguere, MBBS
- Email: osaekhag@iu.edu
- Phone: +1 (317) 944 3691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.