Clinical trial NCT06554522: Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa
Official title: Pragmatic Evaluation of Therapies to Enhance Respiratory Management in Preterm Infants in Africa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Respiratory Distress Syndrome in Premature Infant
RDS of Prematurity
Surfactant Deficiency Syndrome Neonatal
Premature Birth
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Open Philanthropy
First posted: 2024-08-15
Enrollment: 1512
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A stepped wedge cluster randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Hospital Survival
timeFrame: Through hospitalization, an average of 6 months
Secondary outcomes:
measure: Incidence of major preterm neonatal morbidity
timeFrame: Through hospitalization, an average of 6 months
measure: The incidence of pneumothorax
timeFrame: Through hospitalization, an average of 6 months
measure: Hospital survival at seven day
timeFrame: 7 days following birth
Other outcomes:
Locations:
city: Bangui
country: Central African Republic
facility: Centre Hospitalier Universitaire Communautaire
city: Accra
country: Ghana
facility: Korle-Bu Teaching Hospital
city: Kumasi
country: Ghana
facility: Komfo Anokye Teaching Hospital
city: Tamale
country: Ghana
facility: Tamale Teaching Hospital
city: Mombasa
country: Kenya
facility: Coast General Teaching & Referral Hospital
city: Nairobi
country: Kenya
facility: Mama Lucy Kibaki Hospital
city: Ido-Ekiti
country: Nigeria
facility: Federal Teaching Hospital Ido-Ekiti
state: Ekiti
city: Ilorin
country: Nigeria
facility: University of Ilorin Teaching Hospital
state: Kwara
Study officials:
affiliation: Indiana University
name: Osayame A Ekhaguere, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Helen Nabwera, BMedSci
role: PRINCIPAL_INVESTIGATOR
affiliation: Afe Babalola University
name: Olufunke Bolaji, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Edgardo Szyld, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: