Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131625
Status:
COMPLETED
Last Update Posted:
2005-10-10
First Post:
2005-08-18
Brief Title:
Impact of Exclusive Breast-Feeding in Guinea Bissau
Sponsor:
Bandim Health Project
Organization:
Bandim Health Project
Study Overview
Official Title:
Aspects of Exclusive Breast-Feeding in Guinea Bissau Intervention Study to Clarify Recommendations for Breast-Feeding Policy in Developing Countries
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Exclusive breastfeeding is promoted by the World Health Organization WHO with the aim of improving infant health The specific objective of the study was to examine the effect of exclusive breast-feeding on morbidity and mortality in a randomised prospective study Children born by mothers recorded as living in the study area during pregnancy was randomised at birth WHO recommendations to postpone introduction of water and weaning food were told to the mother by 2-weekly home visits All study children were followed from birth till 1 year of age according to morbidity hospitalisation and mortality
Detailed Description:
Examine in a randomised trial whether postponing of introduction of water and weaning food as recommended by WHO reduces infant morbidity and mortality Results obtained from observational studies are likely to be due to reverse causality as the mother her self chooses when to introduce water and weaning food Only a few randomised studies have examined the effect on infant morbidity and no study has investigated the impact on infant mortality in a low-income country The study was conducted at Bandim Health Project BHP which has conducted a demographic health surveillance system since 1978 Mothers and children were identified by the BHP routine registration All children born between March 1 2000 until February 28th 2001 in the study area and whose mothers were recorded as living in the area during pregnancy were eligible for inclusion Children who died within 7 days of birth were excluded in order to avoid birth related morbidity and mortality leaving a total of 1300 children for the study At birth all children were allocated to an intervention group or a control group All mother and child pairs were visited bi-weekly by a local special trained health worker By individual health education the mothers were motivated to delay introduction of water and weaning food to 6 months of age according to recommendations given by WHO All mother and child pairs in the control group were visited by the same health assistant By these visits only information on feeding status was obtained and no intervention given Further more all study children were followed by assistants blinded to the randomisation with bi-weekly diarrhoea morbidity interview monthly anthropometry including weight height and arm circumference All children were followed up to 12 months of age Demographic as well as socio-economic data data on hospitalisation deaths and migrations were obtained from the BHP routine registration system These data will be collected until the age of 3 years of the child
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 104dan8-839 | None | None | None |