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Recruiting NCT06554522

Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

Phase IV Interventional Respiratory Distress Syndrome in Premature Infant RDS of Prematurity Surfactant Deficiency Syndrome Neonatal Premature Birth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surfactant.
Who it may be relevant to
Registry conditions: Respiratory Distress Syndrome in Premature Infant, RDS of Prematurity, Surfactant Deficiency Syndrome Neonatal, Premature Birth. Basic parameters: 1 Hour — 24 Hours · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Central African Republic, Ghana, Kenya, Nigeria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pragmatic Evaluation of Therapies to Enhance Respiratory Management in Preterm Infants in Africa

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Hospital Survival [Time frame: Through hospitalization, an average of 6 months]
Secondary outcome measures (3)
  • Incidence of major preterm neonatal morbidity [Time frame: Through hospitalization, an average of 6 months]
  • The incidence of pneumothorax [Time frame: Through hospitalization, an average of 6 months]
  • Hospital survival at seven day [Time frame: 7 days following birth]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Ghana · 3 centers
  • Korle-Bu Teaching Hospital — Accra
  • Komfo Anokye Teaching Hospital — Kumasi
  • Tamale Teaching Hospital — Tamale
Kenya · 2 centers
  • Coast General Teaching & Referral Hospital — Mombasa
  • Mama Lucy Kibaki Hospital — Nairobi
Nigeria · 2 centers
  • Federal Teaching Hospital Ido-Ekiti — Ido-Ekiti
  • University of Ilorin Teaching Hospital — Ilorin
Central African Republic · 1 center
  • Centre Hospitalier Universitaire Communautaire — Bangui

Identifiers

NCT: NCT06554522 · 22326

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗