Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

NCT06554522 | Recruiting Phase 4 DMC

• 1 other identifier: 22326
• Study Type: interventional
• Target: 1,512
• Locations: 4 countries
• Sites: 8

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Hospital Survival

  Survival to hospital discharge

  Through hospitalization, an average of 6 months

Secondary Outcomes (3)

• Incidence of major preterm neonatal morbidity

  Through hospitalization, an average of 6 months

• The incidence of pneumothorax

  Through hospitalization, an average of 6 months

• Hospital survival at seven day

  7 days following birth

Study Arms (2)

Non-LISA Group

NO INTERVENTION

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

LISA Group

EXPERIMENTAL

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.

Drug: Surfactant

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)

Also known as: Less Invasive Surfactant Administration Technique

LISA Group

Eligibility Criteria

• Age: 1 Hour - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• Coefficient Giving (Formerly Open Philanthropy): collaborator

Study Sites (8)

Centre Hospitalier Universitaire Communautaire

Bangui, Central African Republic

NOT YET RECRUITING

Korle-Bu Teaching Hospital

Accra, Ghana

NOT YET RECRUITING

Komfo Anokye Teaching Hospital

Kumasi, Ghana

NOT YET RECRUITING

Tamale Teaching Hospital

Tamale, Ghana

NOT YET RECRUITING

Coast General Teaching & Referral Hospital

Mombasa, Kenya

NOT YET RECRUITING

Mama Lucy Kibaki Hospital

Nairobi, Kenya

NOT YET RECRUITING

Federal Teaching Hospital Ido-Ekiti

Ido-Ekiti, Ekiti State, Nigeria

RECRUITING

University of Ilorin Teaching Hospital

Ilorin, Kwara State, Nigeria

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome In Premature Infants; Pulmonary Atelectasis; Premature Birth

Interventions

Surface-Active Agents

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Osayame A Ekhaguere, MBBS, MPH

  Indiana University

  PRINCIPAL INVESTIGATOR

• Helen Nabwera, BMedSci

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Olufunke Bolaji, MBBS

  Afe Babalola University

  PRINCIPAL INVESTIGATOR

• Edgardo Szyld, MD, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Osayame A Ekhaguere

CONTACT

+13179443691; osaekhag@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: A stepped wedge cluster randomized controlled trial

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact \*\*\*

Locations

KE (2); GH (3); CE (1); NG (2)