Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
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|ClinicalTrials.gov Identifier: NCT01748929|
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : August 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Intestinal Diseases, Parasitic||Drug: Albendazole Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1010 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth|
|Actual Study Start Date :||February 24, 2014|
|Actual Primary Completion Date :||February 13, 2015|
|Actual Study Completion Date :||September 16, 2016|
single dose 400 mg tablet of albendazole
Placebo Comparator: Placebo
Placebo Manufactured by Hersil Laboratories in Lima, Peru
- Mean (± standard deviation) weight gain (kg) [ Time Frame: Change between birth and six months of age ]
- Infant morbidity [ Time Frame: 1, 6, 12, 24 months following birth ]
- Maternal hemoglobin levels and anemia [ Time Frame: 1, 6, 12, 24 months following birth ]
- Breastfeeding practices [ Time Frame: 1, 6, 12, 24 months following birth ]The prevalence of current, exclusive, predominant and partial breastfeeding will be used to assess breastfeeding practices. In accordance with WHO criteria, infants will be considered as exclusively breastfed if they ingest only breast milk (excluding vitamins and medications); considered as predominantly breastfed if, in addition to breast milk, they also ingest water, juice, teas, vitamins or medications, and considered as partially breastfed if their primary nutrition source is other than breast milk.
- Maternal energy levels [ Time Frame: 1, 6, 12, 24 months following birth ]Maternal energy levels will be measured using an adapted 5-item version of the Fatigue Assessment Scale (FAS) (Michielsen et al. 2004). This scale assesses symptoms of physical and cognitive fatigue.
- Maternal STH infection [ Time Frame: 1 and 6 months following birth ]
- Breast milk quality [ Time Frame: 1 and 6 months following birth ]Mean concentrations of key breast milk quality indicators (i.e. macronutrients, immunological factors, vitamins, and minerals) will be used to assess breast milk quality.
- Breast milk quantity transferred from mother to infant [ Time Frame: 1 and 6 months following birth ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748929
|Asociación Civil Selva Amazónica|
|Principal Investigator:||Theresa W Gyorkos, PhD||McGill University Health Center|
|Principal Investigator:||Martin Casapia, MD, MPH||Asociación Civil Selva Amazónica|