Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

Indiana University

Status and phase: Enrolling; Phase 4

Conditions: RDS of Prematurity; Respiratory Distress Syndrome in Premature Infant; Surfactant Deficiency Syndrome Neonatal; Premature Birth

Treatments: Drug: Surfactant

Study type: Interventional

Funder types: Other

Identifiers

NCT06554522

22326

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,512 estimated patients

Sex: All

Ages: 1 to 24 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Birth weight between 750 and 2000 grams or gestational age between 24- and 35 weeks.
• Silverman Anderson Score ≥5 before or after CPAP treatment.
• Admitted to a study site within 24 hours of life.

Exclusion criteria

• Major congenital or genetic anomalies.
• Active pulmonary hemorrhage.
• Major craniofacial anomalies that preclude the successful use of CPAP

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,512 participants in 2 patient groups

Non-LISA Group

No Intervention group

Description:

Preterm infants with respiratory distress syndrome who are on continuous positive airway pressure support and being treated with caffeine citrate.

LISA Group

Experimental group

Description:

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.

Treatment:

Drug: Surfactant