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OpenTrials
Completed

NCT Number: NCT03520764

To Investigate Effects of a New Infant Formula in Healthy Term Chinese Infants

This study investigates the effects of a new infant formula on growth, safety, and tolerance in healthy term Chinese infants.

Screening starts after the informed consent is obtained. Infants who are less than or equal to 44 days of age and meeting all eligibility criteria will be enrolled into the study. The total duration of the study is around 12 months which includes 8 study visits.

Infants, whose mother has the intention to fully breastfeed her infant at least until 17 weeks of age will be enrolled into the breastfeeding reference group. Infants, whose mother has the intention to fully formula feed her infant as of 44 days of age at the latest, will be randomized to receive either the investigational product or control product until infants reach the age of 17 weeks. After the age of 17 weeks, infants can switch to any feeding and continue be followed up until 12 months of age.

Safety, growth and tolerance parameters will be followed and collected throughout the study.

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Key information

Conditions

Healthy Infants

Age range

Up to 44 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University 3rd Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Chinese term infants ≤ 44 days
  • Birth weight within normal range
  • Head circumference within normal range
  • Fully formula fed by the time of randomization OR fully breastfed and with intention to fully breastfeed until 17 weeks of age

Exclusion criteria

  • The mothers of infants:
  • who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation;
  • known to have a significant medical condition that might interfere with the study or known to affect intra-uterine growth, as per investigator's clinical judgement;
  • Parents/Legally acceptable representatives/Caregivers of infants:
  • who are incapable to comply with study protocol
  • Infants:
  • who have to be fed with a special diet other than standard cow's milk based infant formula;
  • known to have current or previous illnesses/conditions which could interfere with the study products or its outcome parameters
  • known or suspected to have an allergic condition towards cow's milk, soy or fish;
  • with any history of, or current participation in any other study involving investigational or marketed products.

Treatment and study plan

New infant formula with synbiotics

Dietary Supplement

Infants are fed with synbiotics formula for 17 weeks from the date of enrollment.

Standard infant formula with prebiotics

Dietary Supplement

Infants are fed with prebiotics formula for 17 weeks from the date of enrollment.

Primary outcomes

  1. Weight gain per day from baseline (g/day)

    Time frame: at the age of 17 weeks

Secondary outcomes

  1. Weight gain per day from baseline (g/day) in infant receiving test product compared to breastfed infant.

    Time frame: at the age of 17 weeks

  2. Increment per day from baseline on length (mm/day)

    Time frame: at the age of 17 weeks

  3. Increment per day from baseline on head circumference (mm/day)

    Time frame: at the age of 17 weeks

  4. Increment per day from baseline on mid-upper arm circumference (mm/day)

    Time frame: at the age of 17 weeks

  5. Z-scores of anthropometric parameters from baseline on weight

    Time frame: from baseline until the age of 17 weeks

  6. Z-scores of anthropometric parameters from baseline on length

    Time frame: from baseline until the age of 17 weeks

  7. Z-scores of anthropometric parameters from baseline on head circumference

    Time frame: from baseline until the age of 17 weeks

  8. Z-scores of anthropometric parameters from baseline on mid-upper arm circumference

    Time frame: from baseline until the age of 17 weeks

  9. Effect on incidence, frequency and severity of (serious) adverse events

    Time frame: from baseline until the age of 17 weeks

  10. Parent-reported occurrence of diarrhea

    Time frame: from baseline until the age of 17 weeks

  11. Parent-reported severity of diarrhea

    Time frame: from baseline until the age of 17 weeks

  12. Parent-reported occurrence of constipation

    Time frame: from baseline until the age of 17 weeks

  13. Parent-reported severity of constipation

    Time frame: from baseline until the age of 17 weeks

Sponsors and collaborators

Lead sponsor

Danone Nutricia

Industry

Collaborators

  • Nutricia Early Life Nutrition (Shanghai) Co., Ltd

Registry information

Official study title

A Randomised, Controlled, Double-blind Study to Investigate the Effects of a New Infant Formula on Growth, Safety, and Tolerance in Healthy Term Chinese Infants

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 11, 2018
Registry last updated
Feb 26, 2021

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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