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Implementing LISA Surfactant in Nigeria

Primary Purpose

Respiratory Distress Syndrome, Neonatal Death

Status
Recruiting
Phase
Phase 4
Locations
Nigeria
Study Type
Interventional
Intervention
Surfactant
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome

Eligibility Criteria

1 Hour - 2 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Newborns with birth weight between 500-2000 grams (determined by birth weight or admission weight if birth weight is unavailable). ≤48 Hours old at recruitment. Spontaneously breathing but have clinical signs of respiratory distress (defined by Anderson Silverman Score (ASS) ≥4 (range 0-10)) and on CPAP. Admitted to the neonatal/newborn units (or special care nurseries). Exclusion Criteria: Any newborn intubated before admission to the neonatal/newborn units. Any newborn infants with a significant congenital abnormality Any preterm infant considered nonviable by the managing clinician.

Sites / Locations

  • Federal Medical Center AsabaRecruiting
  • University of Benin Teaching HospitalRecruiting
  • National Hospital Abuja
  • Aminu Kano Teaching Hospital
  • Lagos University Teaching Hospital.
  • University of Nigeria Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LISA Arm

Arm Description

Eligible subjects who have respiratory distress syndrome (Anderson Silverman Score >4) managed on continuous positive airway pressure (CPAP) will receive surfactant via a thin catheter while on CPAP.

Outcomes

Primary Outcome Measures

72-hour mortality
All cause mortality with 72-hours of life

Secondary Outcome Measures

In-hospital mortality
All cause mortality during hospitalization
Difference in RDS score before and after the procedure.
Change in Anderson Silverman RDS Score before and after intervention (range: 0 to 10)

Full Information

First Posted
December 28, 2022
Last Updated
August 15, 2023
Sponsor
Indiana University
Collaborators
BLES Biochemicals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05714865
Brief Title
Implementing LISA Surfactant in Nigeria
Official Title
Less Invasive Surfactant Administration in Nigeria
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
BLES Biochemicals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Implement surfactant (BLES®) replacement therapy using the Less Invasive Surfactant Administration technique in six tertiary institutions in Nigeria and evaluate its impact on 72-hour neonatal mortality in premature infants born less than 2000 grams at birth.
Detailed Description
Background: In low- and middle-income countries (LMICs), respiratory distress syndrome (RDS) accounts for ~45% of all in-hospital neonatal mortality. Surfactant use is limited in LMICs, in part, due to the high cost, the lack of skill to perform laryngoscopy and tracheal intubation, and perhaps a perception that surfactant administration and mechanical ventilation must occur together. In LMICs, continuous positive airway pressure (CPAP) is often the highest mode of respiratory support available, and CPAP failure invariably means death. If Less Invasive Surfactant Administration (LISA) can reduce CPAP failure, as shown in high-income settings, it potentially can reduce prematurity-related neonatal mortality in LMICs. There are, however, no studies on how to safely implement LISA in LMICs. The LISA procedure is novel in LMICs; the procedure is not without risk (severe and minor), laryngoscopy is a difficult skill to acquire, master, and maintain, and the resource limitations in LMICs need consideration while implementing LISA. Hypothesis: Compared to a historical control, introducing non-invasive surfactant administration through the less invasive surfactant administration (LISA) techniques will result in a relative risk reduction of all-cause 72-hour in-hospital mortality by at least 20%. PICO Outline: Population: Preterm infants </= 2 kg with respiratory distress defined by a Downes Respiratory Distress Score of >4, who are spontaneously breathing, and on CPAP. Intervention: Surfactant administered through the less invasive surfactant administration (LISA), technique. Comparator: A historical control of preterm babies </= 2 kg with respiratory distress defined by a Downes Respiratory Distress Score of >4, who are spontaneously breathing, and on CPAP. Outcome measures: Primary Outcome: 72-hour all-cause in-hospital mortality. Secondary outcomes All-cause in-hospital mortality Change in respiratory distress score, pre- to -post interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Neonatal Death

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LISA Arm
Arm Type
Experimental
Arm Description
Eligible subjects who have respiratory distress syndrome (Anderson Silverman Score >4) managed on continuous positive airway pressure (CPAP) will receive surfactant via a thin catheter while on CPAP.
Intervention Type
Drug
Intervention Name(s)
Surfactant
Other Intervention Name(s)
BLES® Surfactant, BLEScath™, Less Invasive Surfactant Administration
Intervention Description
Laryngoscopy is performed, and BLES® surfactant is administered through BLEScath™ (a thin catheter) into the trachea to a spontaneously breathing preterm infant with respiratory distress syndrome who is being managed on CPAP
Primary Outcome Measure Information:
Title
72-hour mortality
Description
All cause mortality with 72-hours of life
Time Frame
72 hours of life
Secondary Outcome Measure Information:
Title
In-hospital mortality
Description
All cause mortality during hospitalization
Time Frame
Through hospitalization, an average of 1 day to 10 weeks.
Title
Difference in RDS score before and after the procedure.
Description
Change in Anderson Silverman RDS Score before and after intervention (range: 0 to 10)
Time Frame
6 hours post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newborns with birth weight between 500-2000 grams (determined by birth weight or admission weight if birth weight is unavailable). ≤48 Hours old at recruitment. Spontaneously breathing but have clinical signs of respiratory distress (defined by Anderson Silverman Score (ASS) ≥4 (range 0-10)) and on CPAP. Admitted to the neonatal/newborn units (or special care nurseries). Exclusion Criteria: Any newborn intubated before admission to the neonatal/newborn units. Any newborn infants with a significant congenital abnormality Any preterm infant considered nonviable by the managing clinician.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Osayame A Ekhaguere, MBBS
Phone
+1 (317) 944 3691
Email
osaekhag@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mariya Mukhtar-Yola, MBBS
Phone
+234 802 309 2757
Email
mariyamukhtar@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osayame A Ekhaguere, MBBS, MPH
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal Medical Center Asaba
City
Asaba
State/Province
Delta State
ZIP/Postal Code
11111
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Okolo, MBBS
Phone
+2348023346693
Email
aneneolisa@gmail.com
First Name & Middle Initial & Last Name & Degree
Joseph Ajanwenyi, MBBS
Phone
+2348032874181
Email
josephnwaenyi@gmail.com
Facility Name
University of Benin Teaching Hospital
City
Benin City
State/Province
Edo State
ZIP/Postal Code
11111
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ikechukwu R Okonkwo, MBBS
Phone
+2348036179546
Email
ikeokonkwo2001@yahoo.com
First Name & Middle Initial & Last Name & Degree
Olufemi Olaniyi, MBBS
Phone
+2348057124435
Email
phemmyolaniyi@yahoo.com
Facility Name
National Hospital Abuja
City
Garki
State/Province
FCT Abuja
ZIP/Postal Code
11111
Country
Nigeria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariya Mukhtar -Yola, MBBS, MPH
Phone
+2348023092757
Email
mariyamukhtar@yahoo.com
First Name & Middle Initial & Last Name & Degree
Amsa Mairami, MBBS
Phone
+2348081752303
Email
amsamairami@yahoo.com
Facility Name
Aminu Kano Teaching Hospital
City
Zaria
State/Province
Kano
ZIP/Postal Code
11111
Country
Nigeria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farouk Zubaida, MBBS
Phone
+2348035876567
Email
faroukzubaida@yahoo.com
First Name & Middle Initial & Last Name & Degree
Hadiza Ashiru, MBBS
Phone
+2348035906900
Email
drhaddy@yahoo.com
Facility Name
Lagos University Teaching Hospital.
City
Idi-Araba
State/Province
Lagos
ZIP/Postal Code
11111
Country
Nigeria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chinyere V Ezeaka, MBBS, MPH
Phone
+2348033071230
Email
ezeakac@yahoo.com
First Name & Middle Initial & Last Name & Degree
Iretiola Fajolu, MBBS, MSc
Phone
+2348023076154
Email
iretifaj@yahoo.co.uk
Facility Name
University of Nigeria Teaching Hospital
City
Enugu
ZIP/Postal Code
11111
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenechukwu Iloh, MBBS
Phone
+2348061132883
Email
keneiloh@gmail.com
First Name & Middle Initial & Last Name & Degree
Chinelo Obiora-Izuka, MBBS
Phone
+2348035417424
Email
chineloilz@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
On request and approval from local principal investigators and ethical approval committee

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Implementing LISA Surfactant in Nigeria

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