The effect of 4 or 6 months exclusive breastfeeding on infant breast-milk intake, growth and iron status

Completed

• Conditions: Healthy term infant feeding; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN41946519
• Lead Sponsor: Mead Johnson Nutritionals (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-04
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Healthy term infant (>37 weeks gestation)
2. No health issues affecting growth
3. No other siblings enrolled in the study
4. Exclusively breast-fed at age 4 months

Exclusion Criteria

Infant not exclusively breast-fed at age 4 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Feasibility<br>1.1 Proportion of mothers that will breastfeed exclusively for 6 months <br>1.2 Proportion of mothers randomized at 4 months (from those invited to participate)<br>2. Measurements at 6 months<br>2.1 Infant breast milk intake (by stable isotopes)<br>2.2 Infant growth<br>2.3 Infant iron status

Secondary Outcome Measures

Name	Time	Method
1. Infant food intake<br>2. Infant body composition<br>3. Occurrence of upper respiratory infections and diarrheal episodes (dichotomous variables)