Effects of Early Nutrition on Growth

Infant Newborn Clinical Trial

Official title:

Effects of Early Nutrient Intake on Growth and Body Composition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300000
• Other study ID #: AK65
• Status: Completed
• Phase: N/A
• First received: February 17, 2011
• Last updated: March 27, 2017
• Start date: March 2010
• Est. completion date: August 2016

Study information

• Verified date: March 2017
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to compare the growth of infants fed standard infant formula with infants fed a reduced calorie and protein formula.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 649
• Est. completion date: August 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

Inclusion Criteria:

• good health

• singleton birth with gestational age 37-42 weeks

• infant's birth weight >or = to 2500 grams

• exclusive breastfeeding or exclusively formula feeding

• within a defined geographical boundary

• mother has no problems communicating in English

Exclusion Criteria:

• adverse maternal, fetal or infant medical history

• congenital disease or malformation affecting growth or development

• illness or social problems in mother or infant

• temporary residents

Related Conditions & MeSH terms

• Infant Newborn

Intervention

Other:
• Human Milk
ad lib
• Investigational infant formula
ad lib
• Milk based standard infant formula
ad lib

Locations

Country	Name	City	State
United Kingdom	MRC Childhood Nutrition Research Center, Institute of Child Health	London

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Nutrition	Institute of Child Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vascular		at 24 months
Other	Maternal Anthropometrics		at 24 months
Primary	Weight gain		1- 365 days
Secondary	Gastrointestinal tolerance		1-365 days
Secondary	Infant Anthropometrics		1 - 365 days; 24 months