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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 1 day
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Central African Republic
Centre Hospitalier Universitaire Communautaire
NOT_YET_RECRUITING
Bangui
Ghana
Korle-Bu Teaching Hospital
NOT_YET_RECRUITING
Accra
Komfo Anokye Teaching Hospital
NOT_YET_RECRUITING
Kumasi
Tamale Teaching Hospital
NOT_YET_RECRUITING
Tamale
Kenya
Coast General Teaching & Referral Hospital
NOT_YET_RECRUITING
Mombasa
Mama Lucy Kibaki Hospital
NOT_YET_RECRUITING
Nairobi
Nigeria
Federal Teaching Hospital Ido-Ekiti
RECRUITING
Ido-ekiti
University of Ilorin Teaching Hospital
RECRUITING
Ilorin
Contact Information
Primary
Osayame A Ekhaguere
osaekhag@iu.edu
+13179443691
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 1512
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Open Philanthropy
Leads: Indiana University

This content was sourced from clinicaltrials.gov