- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Quest
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Port-au-Prince, Quest, Haiti
- GHESKIO Centres
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Intervention participant
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in prevalence of growth faltering during the intervention
Lasso di tempo: 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
Lasso di tempo: Six-months post-intervention (approximately 18 months of age)
|
Change in weight-for-age, length-for-age and weight-for-length <-2 SD based on WHO 2006 Growth Standard
|
Six-months post-intervention (approximately 18 months of age)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in prevalence of anemia during intervention
Lasso di tempo: end of intervention (approximately 12 months of age)
|
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
Lasso di tempo: end of intervention (approximately 12 months of age)
|
dietary nutrient intakes assessed through 24-hour dietary recall
|
end of intervention (approximately 12 months of age)
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Rebecca Heidkamp, PhD, Cornell University
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB 0907000316
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Counseling and nutrition supplement
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Alcon ResearchCompletato
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Hacettepe UniversityCompletatoDiabete di tipo 2Tacchino