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OpenTrials
Completed

NCT Number: NCT01721512

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

Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta, Indonesia

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Key information

Conditions

Growth Behavior Breast Feeding Feeding Behavior

Age range

2 week–6 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitas Indonesia

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

breastfeeding

Other

Infant Formula

Other

Primary outcomes

  1. 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 outcomes

  1. Gastrointestinal tolerance

    Time frame: 6 months

    Gastrointestinal tolerance: stool frequency and consistency using Bristol Stool Chart monthly up to 6 months

  2. Indicators or formula tolerance

    Time frame: 12 months

    Indicators or formula tolerance: crying, irritability, sleep patterns

  3. General health

    Time frame: 12 months

    General health: any hospitalisation, doctor visits, symptoms of respiratory or gastrointestinal infection, fever, antibiotic and medication usage

  4. Gut integrity

    Time frame: 3 months

    Gut integrity: faecal Alpha1-antitrypsin and faecal calprotectin

  5. Gut microflora

    Time frame: 3 months

    Gut microflora: real time PCR

  6. Developmental progress

    Time frame: 12 months

    Developmental progress: assessed by Ages and Stages

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Fonterra Brands (Singapore) PTE LTD

Registry information

Official study title

The Growth and Development of Breast and Formula Fed (Containing Synbiotics and LCPUFA) Term Asian Infants.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 5, 2012
Registry last updated
Nov 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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