We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Growth and Development of Breast and Formula Fed Term Asian Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01721512
First Posted: November 5, 2012
Last Update Posted: November 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fonterra Brands (Singapore) PTE LTD
Information provided by (Responsible Party):
Prof. Agus Firmansyah, MD, Ph.D, Indonesia University
  Purpose
Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta, Indonesia

Condition Intervention
Growth Other: Breastfeeding Other: Infant formula

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Growth and Development of Breast and Formula Fed (Containing Synbiotics and LCPUFA) Term Asian Infants.

Resource links provided by NLM:


Further study details as provided by Prof. Agus Firmansyah, MD, Ph.D, Indonesia University:

Primary Outcome Measures:
  • Infant weight, body length head circumference [ Time Frame: 12 months ]
    Infant weight, body length head circumference at enrolment, 2 weeks, 4 weeks and monthly thereafter until 6 months, and then at 8, 10 and 12 months.


Secondary Outcome Measures:
  • Gastrointestinal tolerance [ Time Frame: 6 months ]
    Gastrointestinal tolerance: stool frequency and consistency using Bristol Stool Chart monthly up to 6 months

  • Indicators or formula tolerance [ Time Frame: 12 months ]
    Indicators or formula tolerance: crying, irritability, sleep patterns

  • General health [ Time Frame: 12 months ]
    General health: any hospitalisation, doctor visits, symptoms of respiratory or gastrointestinal infection, fever, antibiotic and medication usage

  • Gut integrity [ Time Frame: 3 months ]
    Gut integrity: faecal Alpha1-antitrypsin and faecal calprotectin

  • Gut microflora [ Time Frame: 3 months ]
    Gut microflora: real time PCR

  • Developmental progress [ Time Frame: 12 months ]
    Developmental progress: assessed by Ages and Stages


Biospecimen Retention:   Samples With DNA
Faecal samples

Enrollment: 160
Study Start Date: September 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Breast-fed infants
80 infants of mothers who plan to exclusively breastfeed for at least 6 months.
Other: Breastfeeding
Formula-fed infants
  1. Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding.
  2. Mother consents to her infant receiving trial infant formula for 12 months
Other: Infant formula

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 6 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy infants recruited from Jati Padang, Pasar Minggu District, South Jakarta, Indonesia
Criteria

Inclusion Criteria:

  • Breast-fed: 1. Mother intends to exclusively breast-feed from birth to at least 4 months; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg.
  • Formula-fed: 1. Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg; 3. Mother consents to her infant receiving trial infant formula for 12 months.

Exclusion Criteria:

  • 1. Severe congenital or metabolic disease likely to affect infant feeding or infant growth.
  • 2. Multiple birth
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721512


Locations
Indonesia
Universitas Indonesia
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Fonterra Brands (Singapore) PTE LTD
Investigators
Principal Investigator: Agus Firmansyah, Professor, MD, PhD, SpA(K) Indonesia University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Agus Firmansyah, MD, Ph.D, Professor and Chief, Division of Gastrohepatology, Department of Child Health, Medical Faculty, University of Indonesia, Indonesia University
ClinicalTrials.gov Identifier: NCT01721512     History of Changes
Other Study ID Numbers: Project Grow
First Submitted: November 1, 2012
First Posted: November 5, 2012
Last Update Posted: November 5, 2012
Last Verified: November 2012

Keywords provided by Prof. Agus Firmansyah, MD, Ph.D, Indonesia University:
Prospective observational study
Breast feeding
Infant formula
Infant
Indonesia