A Phase 4 interventional study of Surfactant in Respiratory Distress Syndrome in Premature Infant, RDS of Prematurity and Surfactant Deficiency Syndrome Neonatal, sponsored by Indiana University. Recruiting at 8 sites in 4 countries. Open to participants aged 1 Hour to 24 Hours. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Indiana University · Phase 4, Interventional, and Treatment
The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable. It will also learn about the safety of the less invasive surfactant administration (LISA) technique. The main questions it aims to answer are:
Does surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries? What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique?
Researchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant.
Participants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will:
Receive surfactant replacement therapy by the less invasive surfactant administration technique.
Be monitored for complications Be followed throughout their hospitalization to determine their survival rate.
The low- and middle-income countries of Sub-Saharan Africa (SSA) carry the highest burden of preterm births and deaths. A primary driver of preterm mortality in SSA is respiratory distress syndrome. Surfactant replacement therapy by the less invasive surfactant administration (LISA) is a technique where the surfactant is administered to a preterm neonate with respiratory distress syndrome managed on continuous positive airway pressure (CPAP), reducing the need for using an invasive mechanical ventilator. In high-income countries, LISA has been shown to be effective in reducing the need for invasive mechanical ventilators and mortality. However, the impact of LISA is unknown in low-resourced settings without ventilators.
The central hypothesis is that implementing LISA in newborn units that care for preterm neonates using standardized CPAP and caffeine citrate will improve survival in preterm neonates.
PICO Outline:
Population: Preterm neonates 750 and 2000 grams or gestational age between 24- and 35 weeks at birth with respiratory distress defined by a Silverman Anderson Score of ≥5, who are spontaneously breathing and on CPAP.
Intervention: Surfactant administered through the less invasive surfactant administration (LISA), technique.
Comparator: Standard of care - standardized CPAP and Caffeine.
Outcome measures: Primary Outcome: All-cause in-hospital survival.
33 studies on the registry are indexed under Respiratory Distress Syndrome In Premature Infants; 9 are open to participants now.
This study's planned enrollment of 1,512 is above the median of 43 across 28 interventional studies indexed under Respiratory Distress Syndrome In Premature Infants.
Browse Respiratory Distress Syndrome In Premature Infants studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
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Exclusion Criteria:
Preterm infants with respiratory distress syndrome who are on continuous positive airway pressure support and being treated with caffeine citrate.
Preterm infants with respiratory distress syndrome, who are on continuous positive airway pressure support are treated with caffeine citrate and surfactant through the less invasive surfactant administration technique.
Drug: Surfactant
Drug pages: Surfactant Excipient · Surface-Active Agent
Surfactant is instilled into the lungs through a thin catheter passed into the trachea during laryngoscopy while on continuous positive airway pressure (CPAP)
Also known as: Less Invasive Surfactant Administration Technique
Hospital Survival
Survival to hospital discharge
Time frame: Through hospitalization, an average of 6 months
Incidence of major preterm neonatal morbidity
Intraventricular hemorrhage, Retinopathy of Prematurity, Bronchopulmonary Dysplasia, Surgical Necrotizing Enterocolitis and Culture Positive Sepsis
Time frame: Through hospitalization, an average of 6 months
The incidence of pneumothorax
Air leaks into the space between your lung and chest wall
Time frame: Through hospitalization, an average of 6 months
Hospital survival at seven day
Survival rates assessed at day seven of life
Time frame: 7 days following birth
Plan to share: Yes — Data obtained through this study may be provided to qualified researchers with academic interest. The data shared will be coded, with no personal health information included. Approval of the request and execution of all applicable agreements (e.g., a material transfer agreement) are prerequisites to sharing data with the requesting party.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact ***
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Studies of the drugs tested here: Surfactant Excipient · Surface-Active Agent
Respiratory Distress Syndrome In Premature Infants →