Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
Study Details
Study Description
Brief Summary
Women of reproductive age are considered a high-risk group for worm infections by the World Health Organization. Maternal infection and anemia contribute to infant malnutrition by affecting milk quality and quantity, and duration of exclusive breastfeeding. To date, no study has investigated the health benefits of postpartum deworming to infants or mothers. A randomized controlled trial will be conducted in Peru to investigate the effectiveness of integrating deworming into routine postpartum care. The primary measure of effect will be infant weight gain between birth and six months of age. Other infant and maternal health indicators will also be ascertained.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Albendazole single dose 400 mg tablet of albendazole |
Drug: Albendazole
|
| Placebo Comparator: Placebo Placebo Manufactured by Hersil Laboratories in Lima, Peru |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Mean (± standard deviation) weight gain (kg) [Change between birth and six months of age]
Secondary Outcome Measures
- Infant morbidity [1, 6, 12, 24 months following birth]
- Maternal hemoglobin levels and anemia [1, 6, 12, 24 months following birth]
- Breastfeeding practices [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 [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 [1 and 6 months following birth]
- Breast milk quality [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 [1 and 6 months following birth]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Deliver at Hospital Iquitos
-
Plan to reside in Iquitos or neighbouring area for the next 24 months
-
Able to communicate in Spanish
Exclusion Criteria:
-
Deliver multiples
-
Delivery a stillborn or an infant with a serious congenital medical condition
-
Transfered to another hospital prior to discharge
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Asociación Civil Selva Amazónica | Iquitos | Peru |
Sponsors and Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
- Principal Investigator: Theresa W Gyorkos, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Principal Investigator: Martin Casapia, MD, MPH, Asociación Civil Selva Amazónica
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12-198-GEN