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Completed

NCT Number: NCT03991949

Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula

This single-group study will assess growth and tolerance of infants fed a post-discharge preterm infant formula containing a prebiotic.

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Key information

Conditions

Infant Development

Age range

34 week–41 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida, Tampa, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Gestational age at birth less than 37 weeks
  • Birth weight less than 3200 g (approximately 7 pounds)
  • Postmenstrual age is 34 0/7 through 41 0/7 weeks at enrollment
  • Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
  • The currently-fed formula is a milk-based infant formula at a caloric density of ≤ 24 Cal/fl oz.
  • Singleton, twin, or triplet births only.
  • Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
  • Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion criteria

  • An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
  • Participant is taking and plans to continue taking medications, home remedies, herbal preparations, prebiotics or probiotics, rehydration solutions, or parenteral nutrition
  • Participant is known to require elective surgery with hospitalization, other than uncomplicated outpatient surgery, during the course of the study.
  • Participant is in another study that has not been approved as a concomitant study
  • Participant has an allergy or intolerance to any ingredient in the study product
  • Participant is currently receiving oxygen therapy
  • Participant is currently receiving antibiotics
  • Participant is currently receiving tube feedings

Treatment and study plan

Experimental Infant Formula

Other

Formula fed Ad libitum

Primary outcomes

  1. Weight

    Time frame: SDAY 1 to SDAY 56

    Change in weight-for-age z-score

Secondary outcomes

  1. Stool Characteristics

    Time frame: Study Day (SDAY) 1 to SDAY 56

    Parent completed diary

  2. Formula Intake

    Time frame: SDAY 1 to SDAY 56

    Parent completed diary

  3. Length

    Time frame: SDAY 1 to SDAY 56

    Interval length gain per day

  4. Head Circumference

    Time frame: SDAY 1 to SDAY 56

    Interval HC gain per day

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula With Prebiotic

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 19, 2019
Registry last updated
Dec 13, 2022

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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