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OpenTrials
Completed

NCT Number: NCT00984230

A New Adaptive Feeding Plan for Newborns

The purpose of this clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies.

Completed

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Key information

Conditions

Infant Nutrition

Age range

1 day–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatrics, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy newborn infant
  • Full term infant (≥ 37 weeks gestation; < 42 weeks gestation)
  • Birth weight from 2500g to 4500g
  • For the formula-fed groups: babies whose mothers elected not to breastfeed at all
  • For the breastfed group: babies whose mothers elected to exclusively breastfeed for at least 2 months
  • Newborn whose parents / caregivers can be expected to comply with the protocol
  • Study explained and written information given
  • Informed consent signed

Exclusion criteria

  • Mother who had antibiotics in the 7 days preceding delivery
  • Caesarian section
  • Multiple birth
  • Congenital illness or malformation that may affect normal growth
  • Significant pre-natal and/or post-natal disease
  • Newborn participating in another clinical trial

Treatment and study plan

BSF

Other

feeding amount according to individual baby need

BSF + Lactoferrin + Probiotics

Other

feeding amount according to individual baby need

BSF + Lactoferrin + Probiotics + OS

Other

feeding amount according to individual baby need

Primary outcomes

  1. gut maturation : Specific proteins in stools

    Time frame: 3rd day, at 1 week, 2 weeks and 1 month of age

Secondary outcomes

  1. Growth and gut microbiota

    Time frame: At 1 month and 2 months

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

A New Adaptive Feeding Plan for Newborns: Effects on Gut Maturity and Gut Microbiota

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 25, 2009
Registry last updated
Jun 5, 2013

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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