- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01434238
Evaluation of an Infant Feeding Intervention for HIV-exposed Haitian Infants
Evaluation of an Infant Feeding Support Strategy for HIV-exposed Infants 6-12 Months Old in Urban Haiti
연구 개요
상태
상세 설명
The need for better nutrition during infancy to improve growth and child survival outcomes is well recognized and is especially acute in the context of maternal human immunodeficiency virus (HIV) infection. WHO Guidelines on Infant Feeding and HIV call for support of HIV-infected caregivers during infant feeding transitions across the first year of life. However, there are few published examples of programmatic approaches that effectively integrate PMTCT and infant feeding support at the service delivery level.
The objectives of this study are to develop and test an infant feeding support intervention among non-breastfed HIV-exposed infants age 6-12 months enrolled in the Prevention of Mother-to-Child Transmission of HIV program at the GHESKIO centres, an HIV and TB treatment clinic in urban Port-au-Prince, Haiti. The investigators hypothesize that growth and anemia outcomes will be better in the intervention cohort compared to historical controls. The investigators also hypothesize that the infant feeding support intervention will be feasible and acceptable to mothers and clinical staff.
To accomplish these objectives, the investigators will enroll 82 HIV-exposed infants age 5.5-6.5 months recruited from the GHESKIO pediatric clinic in a 24-week intervention that includes a) a daily ration of fortified lipid-based nutrient supplement and b) nutrition counseling delivered through biweekly group and individualized sessions. Data on growth, supplement use, infant feeding knowledge and practices will be collected every 4 weeks during the intervention period. Hemoglobin and dietary intake will be assessed at baseline, mid-point and end of intervention. Intervention children will be seen 6-months post intervention to assess growth and anemia outcomes. Growth and anemia outcomes in the intervention group will be compared to medical record data from same-age HIV-exposed children seen at GHESKIO in the previous year.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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Quest
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Port-au-Prince, Quest, 아이티
- GHESKIO Centres
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Confirmed maternal HIV-infection
- Age 5.5-6.5 months at intervention start
- Weight-for-length z-score > -3 SD (WHO 2006 reference)
Exclusion Criteria:
- Confirmed or suspected allergy to peanuts
- Participation in a concurrent clinical trial at GHESKIO
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Intervention participant
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24-week intervention that includes a) a daily ration of fortified lipid-based nutrient supplement and b) nutrition counseling delivered through biweekly group and individualized sessions.
Dietary supplement is a locally- produced lipid-based nutrient spread (Meds and Foods for Kid, Cap Haitian, Haiti) that in a 65g daily ration provides 345 kcal energy and single allowance of key micronutrients for the 6-12 month age group.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in prevalence of growth faltering during the intervention
기간: end of intervention (approximately 12 months of age)
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Change in weight-for-age, length-for-age and weight-for-length <-2 SD based on WHO 2006 Growth Standard
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end of intervention (approximately 12 months of age)
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Change in prevalence of growth faltering post-intervention
기간: Six-months post-intervention (approximately 18 months of age)
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Change in weight-for-age, length-for-age and weight-for-length <-2 SD based on WHO 2006 Growth Standard
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Six-months post-intervention (approximately 18 months of age)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in prevalence of anemia during intervention
기간: end of intervention (approximately 12 months of age)
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Prevalence of anemia (Hb < 10.5 g/dl)
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end of intervention (approximately 12 months of age)
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Dietary intake
기간: end of intervention (approximately 12 months of age)
|
dietary nutrient intakes assessed through 24-hour dietary recall
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end of intervention (approximately 12 months of age)
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Rebecca Heidkamp, PhD, Cornell University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Counseling and nutrition supplement에 대한 임상 시험
-
Jimma University알려지지 않은