Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

Sponsor
Indiana University
Study ID
NCT06554522
Phase
PHASE4
Status
Recruiting
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Conditions

  • Premature Birth
  • RDS of Prematurity
  • Respiratory Distress Syndrome in Premature Infant
  • Surfactant Deficiency Syndrome Neonatal

Eligibility Criteria

Sex
ALL
Age
1 Hour - 24 Hours
Healthy Volunteers
Not accepted

Interventions

  • Surfactant — DRUG
    Surfactant is instilled into the lungs through a thin catheter passed into the trachea during laryngoscopy while on continuous positive airway pressure (CPAP)

Study Details

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.

Key Dates

First listed
Aug 15, 2024
Start date
Jan 1, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
1,512 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • No Intervention: Non-LISA Group
    Preterm infants with respiratory distress syndrome who are on continuous positive airway pressure support and being treated with caffeine citrate.
  • Experimental: LISA Group
    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.

Primary Outcome Measure

Hospital Survival [ Time Frame: Through hospitalization, an average of 6 months ]

Central Contacts

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