Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

March 23, 2026 updated by: Osayame Ekhaguere, Indiana University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1512

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Osayame A Ekhaguere
  • Phone Number: +13179443691
  • Email: osaekhag@iu.edu

Study Locations

  • Central African Republic
      • Bangui, Central African Republic
        • Not yet recruiting
        • Centre Hospitalier Universitaire Communautaire
        • Contact:
  • Ghana
      • Accra, Ghana
      • Kumasi, Ghana
        • Not yet recruiting
        • Komfo Anokye Teaching Hospital
        • Contact:
      • Tamale, Ghana
        • Not yet recruiting
        • Tamale Teaching Hospital
        • Contact:
  • Kenya
      • Mombasa, Kenya
        • Not yet recruiting
        • Coast General Teaching & Referral Hospital
        • Contact:
      • Nairobi, Kenya
        • Not yet recruiting
        • Mama Lucy Kibaki Hospital
        • Contact:
  • Nigeria
    • Ekiti State
      • Ido-Ekiti, Ekiti State, Nigeria
    • Kwara State
      • Ilorin, Kwara State, Nigeria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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)
Other Names:
  • Less Invasive Surfactant Administration Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Survival
Time Frame: Through hospitalization, an average of 6 months
Survival to hospital discharge
Through hospitalization, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of major preterm neonatal morbidity
Time Frame: Through hospitalization, an average of 6 months
Intraventricular hemorrhage, Retinopathy of Prematurity, Bronchopulmonary Dysplasia, Surgical Necrotizing Enterocolitis and Culture Positive Sepsis
Through hospitalization, an average of 6 months
The incidence of pneumothorax
Time Frame: Through hospitalization, an average of 6 months
Air leaks into the space between your lung and chest wall
Through hospitalization, an average of 6 months
Hospital survival at seven day
Time Frame: 7 days following birth
Survival rates assessed at day seven of life
7 days following birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Coefficient Giving (Formerly Open Philanthropy)

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data obtained through this study may be provided to qualified researchers with academic interest. The data shared will be coded, with no personal health information included. Approval of the request and execution of all applicable agreements (e.g., a material transfer agreement) are prerequisites to sharing data with the requesting party.

IPD Sharing 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

IPD Sharing 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 ***

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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