- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04893616
Cameroon HepB Birth Dose Feasibility Pilot
Improving Timeliness of Birth Dose Vaccines in 15 Health Facilities in Cameroon Through Integrating Immunizations Into Maternity and Newborn Care Services: A Feasibility Assessment
연구 개요
상세 설명
In the Cameroon Expanded Program on Immunization (EPI), the birth dose vaccine for oral polio vaccine (OPV-0) and tuberculosis vaccine (BCG), are recommended with a third birth dose vaccine for hepatitis B (HepB-BD) being considered for introduction.
Although Cameroon introduced the HepB antigen as part of the Pentavalent vaccine into the immunization program in 2005, infants are currently unprotected until the first Penta shot at six weeks. Introduction of HepB-BD is a key priority for the Cameroon government through the National Cancer Strategy document as well as the Hepatitis Prevention and Treatment Guidelines. However, the timeliness of administration of Hepatitis B vaccine within 24 hours of birth is critical to ensure the highest efficacy and prevent transmission of the virus.
While coverage rates for BCG and OPV 0 are relatively high (91% and 78% respectively), these vaccines are often administered weeks or months after birth , not within the 24-hour timeframe recommended for Hepatitis B birth dose. Therefore, there are concerns from the Cameroon National Immunization Technical Advisory Group (NITAG) and other stakeholders on the feasibility of achieving high timely coverage of HepB-BD. The timeliness of administration of the birth dose vaccines within facilities relies on many system components including integrated processes between maternity and immunization units and healthcare worker awareness of birth dose administration guidelines.
The main aim of this pilot study is to assess the feasibility of immunizing newborns with BCG and OPV0 (and eventually HepB-BD) within 24 hours of birth by integrating routine immunization into maternity and immediate newborn care in 15 facilities in Cameroon.
Further, the specific objectives of this pilot study are to:
- Integrate birth dose immunizations into maternity and immediate newborn care services
- Measure the change in proportion of newborn receiving birth doses BCG and OPV0 within 24 hours compared to baseline data
- Measure the change in average age of babies receiving birth doses of BCG and OPV0
- Assess the operational feasibility and acceptability of interventions and describe any factors (barriers and enablers) that may influence further implementation of birth dose strategies
This feasibility assessment is to provide quantitative findings of an intervention integrating immunizations into maternity and newborn care across 15 health facilities in Cameroon. Overall, in 20 weeks an intervention phase will be followed by a final assessment. The approach will utilize quantitative data from healthcare worker surveys, the birth registry and immunization registry, and maternity unit reporting forms. The study findings will be used to inform strategy on HepB-BD introduction in Cameroon as well as interventions to strengthen service delivery structures for newborns.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Adamawa
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Dibi, Adamawa, 카메룬
- CMA Dibi
-
-
Adamawe
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Mbe, Adamawe, 카메룬
- CMA Mbe
-
-
Center
-
Biyem Assi, Center, 카메룬
- HD Biyem-Assi
-
Cite Verte, Center, 카메룬
- HD Cite Verte
-
Djoungolo, Center, 카메룬
- CMMR Etoudi
-
Efoulan, Center, 카메룬
- CMA Ahala
-
Mbalmayo, Center, 카메룬
- CSIU Mbalmayo II
-
Mfou, Center, 카메룬
- CSC Nkoabang
-
Nkolndongo, Center, 카메룬
- Hospital Nicolas Barre
-
Obala, Center, 카메룬
- HD Obala
-
-
West
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Baham, West, 카메룬
- CSC Baham
-
Foumbot, West, 카메룬
- HD Foumbot
-
Mifi, West, 카메룬
- HD Mifi
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Facilities will be those that have both an immunization unit as well as a maternity ward
Exclusion Criteria:
- Facilities without both units
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Intervention Arm
These facilities will be those selected to have the intervention carried out.
|
The purpose of the work is to integrate readily available birth dose vaccinations (Oral Polio and the Tuberculosis vaccine) currently given in a separate clinic into the maternity delivery services through improved training, checklist, and job aides.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Timeliness of birth dose vaccine administration
기간: 20 weeks
|
Median hours between birth and administration of oral polio and/or the BCG vaccine
|
20 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Coverage of birth dose vaccines
기간: 20 weeks
|
The proportion of children born in the facility that obtain an oral polio and/or BCV vaccine
|
20 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ankouane Andoulo Firmin, Faculty of Medicine and Bio-Medical Sciences, University of Yaoundé
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2020/09/1695/L/CNERSH/SP
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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