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OpenTrials
Completed

NCT Number: NCT02911454

Assess the Effects of Infant Formula on Infant Stool Characteristics, Behaviour and Parental Experience in Everyday Situations

A prospective, multi-country, open label study to describe the stool characteristics and behaviour as well as the parents' experience in infants receiving a recently launched infant formula in a real life situation.

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Key information

Conditions

Healthy

Age range

1 hour–6 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private practice, Bischofshofen, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy term infants, gestational age up to and including 37 weeks and 42 weeks and below. Healthy is defined as "no supervision or medical treatment by a medical specialist. Further more to be determined by HCP.
  • Birth weight between 2.5 - 4.5 KG (within normal range for gestational age and sex)
  • Infants up to 6 weeks of postnatal age (Including day 42)
  • Receiving exclusively or at least 1 complete infant formula feeding per day at study inclusion (retrospectively exclusively or partly formula fed)
  • Willingness to change from their regular infant formula to study product
  • Parents' or legal guardians' aged up to and including 18 years, written, informed consent.

Exclusion criteria

  • Infants with a congenital condition and / or previous or current illness and (or) medication that could interfere with the study
  • Infants with established or suspected cows milk allergy, lactose intolerance, galactosaemia or infants on a prescribed fibre free (e.g. prebiotic oligosaccharides) diet
  • Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study
  • Investigator's uncertainty about the willingness of the parents / legal guardians to comply with the protocol requirements.

Treatment and study plan

Infant Formula

Other

Primary outcomes

  1. Stool consistency measured by Amsterdam Stool Scale.

    Time frame: 15 months

    Will be reported in diaries completed by the parents.

  2. Crying time

    Time frame: 15 months

    Will be reported in diaries completed by the parents.

  3. Stool frequency

    Time frame: 15 months

    Will be reported in diaries completed by the parents.

Secondary outcomes

  1. Eating behaviour

    Time frame: 15 months

    Baby Eating Behaviour Questionnaire

  2. Parental experience of child behaviour

    Time frame: 15 months

    PedsQL,

  3. Impact on family life

    Time frame: 15 months

    FamPedsQL

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 22, 2016
Registry last updated
Sep 14, 2017

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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