Status:

COMPLETED

Effect of Formula on Growth of Infants From Overweight or Obese Mothers

Lead Sponsor:

Société des Produits Nestlé (SPN)

Conditions:

Infant Nutrition

Eligibility:

All Genders

3-12 years

Phase:

NA

Brief Summary

The purpose of this study is to determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth

Eligibility Criteria

Inclusion

  • healthy newborn infant
  • birth weight between 2500g and 4800g
  • singleton birth
  • mother's BMI before pregnancy was between 26 and 25
  • for the breastfeeding group: mother has elected to exclusively breastfeed her baby from birth to at least 6 months of age
  • for the formula groups: mother has elected to exclusively formula feed her baby from 3 to 6 months of age
  • having obtained signed informed consent of legal representative

Exclusion

  • body weight smaller than 5th percentile for that gestational age
  • newborn whose mother has diabetes
  • newborn whose mother has a drug dependence during pregnancy
  • newborn currently participating in another trial

Key Trial Info

Start Date :

October 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2014

Estimated Enrollment :

230 Patients enrolled

Trial Details

Trial ID

NCT00820833

Start Date

October 1 2007

End Date

December 1 2014

Last Update

March 26 2015

Active Locations (1)

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Departamento de Medicina Interna, University de la Frontera

Temuco, Chile