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OpenTrials
Completed

NCT Number: NCT01808105

Growth and Tolerance of Infants Fed Infant Formulas

To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.

Completed

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Key information

Age range

Up to 5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Puerto Rico, Guayama, Puerto Rico

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Singleton from full term birth with a gestational age 37-42 weeks
  • Birth weight > 2490 g (~5 lbs 8 oz)
  • Between 0 and 5 days of age
  • Smoke-free home (no smoking in the house dwelling), and mothers in the breast-fed group are prohibited from smoking during the study period
  • Parent(s) of formula-fed infants have elected not to breastfeed and confirm that their infant has been exclusively formula-fed since birth and confirm their intention is to exclusively feed their infant study infant formula for the duration of the study,
  • Parent(s) of human milk-fed infants have elected to breastfeed and confirm that their infant has been exclusively human milk-fed (not donor milk) since birth and confirm their intention is to continue to exclusively feed human milk with vitamin/mineral supplementation for the duration of the study
  • No administration vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D, if recommended by a healthcare professional), solid foods or juices to infants from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional

Exclusion criteria

  • Adverse maternal, fetal or infant medical history that has potential effects on tolerance, growth, and/or development
  • Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance may not be enrolled
  • Treatment with antibiotics
  • Mother intends to use a combination of breast and formula feeding

Treatment and study plan

Control Formula

Other

Feeding ad libitum

Other names: Commercially available Infant Formula

Experimental Formula 1

Other

Feeding ad libitum

Experimental Formula 2

Other

Feeding ad libitum

human milk

Other

Feeding ad libitum

Other names: Breast feeding group

Primary outcomes

  1. Weight

    Time frame: Study Day (SD) 14 - 119

    Weight gain per day

Secondary outcomes

  1. Stool Characteristics

    Time frame: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits

    Stool consistency and number per day

  2. Feeding Tolerance

    Time frame: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits

    % of feedings with spit up associated with feeding

  3. Length

    Time frame: Study Day (SD) 1, 14, 28, 42, 84 and 119 visits

    Length and interval length gain per day

  4. Head Circumference

    Time frame: Study Day (SD) 1, 14, 28, 42, 84 and 119 visits

    Head circumference (HC) and interval HC gain per day

Other outcomes

  1. Study Formula Intake

    Time frame: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits

    Average volume of study formula intake and average number of study formula feedings per day

  2. Oligosaccharides

    Time frame: Study Day (SD) 42 and 119 visits

    Infant urine sample

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Growth and Tolerance of Young Infants Fed Infant Formulas

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 11, 2013
Registry last updated
Jun 2, 2014

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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