utritional management of growth faltering in infants aged under six months in Asia and Africa (BRANCH, Breastfeeding counselling and management of growth)

Not Applicable

Conditions: Faltering growth
Diet and Nutrition - Other diet and nutrition disorders
Public Health - Health promotion/education

Registration Number: ACTRN12624000704594

Lead Sponsor: World Health Organization

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 9900

Inclusion Criteria

Age of baby > = 7 and < 14 days
-Ultrasound-based gestational age before 20 weeks of gestation is available
-Baby is 28 weeks gestation or more
-Birth weight taken within 72 hours after birth
-Baby has been fed breastmilk at any time since birth

Exclusion Criteria

-The biological mother is dead at the time of screening
-Baby has a major abnormality or condition which is impairing feeding or nutrition (such as severe cleft palate, severe asphyxia, severe respiratory distress syndrome, need for mechanical ventilation, severe necrotising enterocolitis, major surgery)
-Family does not intend to live in the study area for six months
-The mother has given birth to three or more babies (ie twins are included but triplets or quadruplets etc are excluded)
-A baby from the same household is currently part of the study (i.e. is being visited by the study team).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wasting free survival at 6 completed months of age = composite outcome = all cause mortality or wasting (wasting is defined as weight for length z score less than 2 standard deviation (sd) scores below the median of the WHO Growth Standards). [Mortality data will be collected during visits by trained field workers to the infant’s home. The legal guardian will be asked about the infant’s vital status (ie alive, deceased, temporarily absent, if died date of death). This information will be recorded on a trial specific questionnaire. <br><br>Weight and length will be measured by trained field workers during a home visit using calibrated anthropometric scales using standardised procedures. This information will be recorded on a trial specific questionnaire.<br> 6 completed months of age (chronological age).]

Secondary Outcome Measures