|- candidate number||11052|
|- NTR Number||NTR3273|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-jan-2012|
|- Secondary IDs||2010/264 METC VU University Medical Center|
|- Public Title||Feeding practices in Guatemalan infants: Adherence to the WHO recommendations and barriers to their implementation.|
|- Scientific Title||Feeding practices in Guatemalan infants: Adherence to the WHO recommendations and barriers to their implementation.|
|- hypothesis||1. That adherence to the WHO recommendations (2003) for early child feeding among low-income Quetzaltenango mothers, specifically exclusive breastfeeding up to 6 months, is associated with higher growth attainment and greater disease resistance;|
2. That a combination of quantitative and qualitative data on early infant feeding practices of mothers in Quetzaltenango can provide evidence on which to base public action to eliminate barriers to appropriate feeding and to base counselling guidance and public action to generalize the determinant variables of “successful mothers” across the sector, with a high probably to increase adherence in the low-income community of Quetzaltenango.
|- Healt Condition(s) or Problem(s) studied||Breastfeeding , Early feeding practices, Morbidity|
|- Inclusion criteria||1. Aged 0 to 5 months;|
2. Full-term infant;
3. No congenital anomalies or chronic illness;
4. Mother willing to sign the study consent form;
5. Currently breastfeeding.
|- Exclusion criteria||1. Pre-mature infant (defined as born more than four weeks pre-term);|
2. Had siblings who were already participants;
3. Had congenital anomalies or chronic illness;
4. Failed to sign the study consent form.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||Single arm|
|- planned startdate ||1-jan-2011|
|- planned closingdate||1-mrt-2012|
|- Target number of participants||380|
|- Primary outcome||Self reported feeding practices and morbidity incidence (collected by face-to-face interviews) and growth (based on measurements of mother and child).|
|- Secondary outcome||Rates of exclusive and predominant breastfeeding rates.|
|- Timepoints||A cross-sectional sample of 300 mother-infant dyads will be interviewed once and anthropometric measurements of mother and infant will be collected on a single occasion.|
In addition, 80 infants will be interviewed and measured on 3 separate occasions with a 2 month time interval.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. Marieke Vossenaar|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Marieke Vossenaar|
|- Sponsor/Initiator ||Vrije Universiteit Amsterdam, Center for Studies of Sensory Impairment, Aging and Metabolism (CeSSIAM)|
(Source(s) of Monetary or Material Support)
|Nestle Foundation, Switzerland|
|- Brief summary||The promotion of adequate feeding practices is essential to achieving optimal infant and child health, growth, and development. The WHO recommends initiation of breastfeeding in the first hours after birth and exclusive breastfeeding for the first 6 months of age.|
Guatemala’s high prevalence of childhood chronic malnutrition may be related to suboptimal early infant feeding practices. Between 2000 and 2007 only 51% of Guatemalan infants were exclusively breastfed for 6 months and only 67% of infants 6-9 months were partially breastfed. In low-income peri-urban Guatemala, were 42% of the children under 3 years of age are chronically malnourished, most mothers (79%) did not initiate breastfeeding in the first hour and only 14-23% of infants were exclusively breastfed for the first 6 months of life. Additionally, by 2 months of age, 39% were exposed to bottle feeding, which may lead to microbial contamination.
The proposed study aims to monitor the adherence to the WHO recommendations in infants until 6 months in the urban areas of Quetzaltenango, the second largest city of Guatemala located in the highland region. Half the population is of Mayan origin and the other half is Ladina, and both groups are undergoing rapid urban and economic development.
We shall determine if mothers are adhering to the WHO early feeding practices, and examine the barriers to this recommended behaviour. Length of exclusive breastfeeding, predominant breastfeeding and any breastfeeding and the determinants for the changes in intensity will be examined. Quantitative methods will be used to identify the feeding practices most related to poor child health outcomes, whereas qualitative methods will be used to explore reasons for these behaviours. Lessons from “successful mothers” will be derived to improve adherence to the WHO early feeding recommendations according to the Positive Deviance approach.
|- Main changes (audit trail)|
|- RECORD||30-jan-2012 - 14-feb-2012|