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Completed

NCT Number: NCT04055363

Human Milk Oligosaccharides (HMOs) Post-market Study on Infants

Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT). Two published RCTs have demonstrated that infant formulas supplemented with 2'FL or 2'FL+LNnT are safe, well-tolerated, support normal grow, and may support healthy GI function and confer immune benefits. The performance of HMOs-supplemented formulas assessed in a real-world setting is complementary to previously conducted RCTs conducted in highly controlled clinical settings. Main objectives will be to monitor the safety & tolerance of HMOs-supplemented formulas in larger and diverse infant populations; to assess the performance of HMOs-supplemented formulas in mixed-fed infants, a population that was not studied in previous RCTs but likely represents a relatively common feeding regimen. Finally, considering the potential health/immune benefits of HMOs, it is also important explore the incidences of illnesses (i.e., respiratory illnesses, GI illnesses, and fever) associated with consuming HMOs-supplemented formulas and compare with breastfed infants data.

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Key information

Conditions

Growth Adverse Event Digestive System Diseases Disorder Lung Disorder of Intestine Gastrointestinal Diseases Infections Intestinal Diseases Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Tolerance

Age range

7 day–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vitha Santa Catalina Hospital, Las Palmas de Gran Canaria, Canary Islands, Spain

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About this study

Objectives:

The main objective of this study is to document the growth and feeding tolerance of healthy term infants consuming an infant formula supplemented with HMOs for 8 weeks (56 days), in a real-world setting.

Main endpoints:

  • Growth documented via monitoring the anthropometric parameters including weight, length, head circumference, BMI and their corresponding z-scores (i.e., z-scores for weight-for-age, length-for-age, weight-for-length, head circumference-for-age, and BMI-for-age) calculated using the 2006 WHO Growth Standards
  • Feeding tolerance assessed via monitoring parent-reported overall GI symptom burden measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score (13-item summary score)

Additional objectives:

To describe the following outcomes in infants fed an infant formula supplemented with HMOs:

  • Formula acceptability
  • Despite there are no expected safety concerns, standard Adverse Events (AEs) monitoring will be implemented during the study

Additional endpoints:

  • Formula acceptability assessed by the Study Formula Satisfaction Questionnaire
  • Reported AEs and Serious Adverse Events (SAEs) including type, incidence, severity, seriousness and relation to study formula consumption as well as concomitant medications and non-pharmacological treatments.
  • Select morbidities of interest (i.e., respiratory illnesses, GI illnesses, and fever) will be collected as part of AE reporting and specific corresponding AE guidance forms will be used to standardize reporting of such AEs

Trial design:

Uncontrolled, single arm, open-label, prospective study in infants (enrolled at postnatal age 7 days to 2 months) fed the study formula for 8 weeks (56 days)

A group of exclusively breastfed infants (BF) will serve as a reference group in parallel to the study arm. For the BF group, Infants must have been exclusively consuming breast milk since birth, and their parent(s) must have made the decision to continue exclusively breastfeeding until at least 4 month of age

Trial population:

Healthy, male and female, term infants, 7 days postnatal age to 2 months of age at the enrollment

Treatment duration:

Total study participation/intervention up to approximately 8 weeks

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) have been informed of all pertinent aspects of the study
  • Parent(s) are willing and able to fulfill the requirements of the study protocol
  • Healthy full term (37-42 weeks gestation) infant
  • Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
  • Parent(s) must have independently elected, before enrollment, to formula feed

Exclusion criteria

  • Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) have been informed of all pertinent aspects of the study
  • Parent(s) are willing and able to fulfill the requirements of the study protocol
  • Healthy full term (37-42 weeks gestation) infant
  • Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
  • Infants must have been exclusively consuming breast milk since birth, and their parent(s) must have made the decision to continue exclusively breastfeeding until at least 4 month of age

Treatment and study plan

HMO-supplemented infant formula

Other

Starter Infant Formula supplemented with 1.5g/L of Human Milk Oligosaccharides

Primary outcomes

  1. World Health Organization (WHO) based weight-for-age z-scores

    Time frame: 8 weeks (study end)

    Weight-for-age z-scores using WHO growth standards

  2. World Health Organization (WHO) based length-for-age z-scores

    Time frame: 8 weeks (study end)

    Length-for-age z-scores using WHO growth standards

  3. World Health Organization (WHO) weight-for-length z-scores

    Time frame: 8 weeks (study end)

    Weight-for-length z-scores using WHO growth standards

  4. World Health Organization (WHO) head-circumference-for-age z-scores

    Time frame: 8 weeks (study end)

    head-circumference-for-age z-scores using WHO growth standards

  5. World Health Organization (WHO) based body-mass-index (BMI)-for-age z-scores

    Time frame: 8 weeks (study end)

    Weight and height will be combined to calculate BMI in kg/m^2, then BMI-for-age z-scores will be derived using WHO growth standards

  6. Feeding tolerance

    Time frame: 4 weeks (study midpoint)

    The Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score will be used to assess GI distress. This is a validated 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress. A composite IGSQ score is derived from summing the individual scores with a possible range of 13 to 65 where higher values indicate greater GI distress and values ≤23 indicate no digestive distress.

  7. Feeding tolerance

    Time frame: 8 weeks (study end)

    The Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score will be used to assess GI distress. This is a validated 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress. A composite IGSQ score is derived from summing the individual scores with a possible range of 13 to 65 where higher values indicate greater GI distress and values ≤23 indicate no digestive distress.

Secondary outcomes

  1. Formula acceptability

    Time frame: 4 weeks (study midpoint), 8 weeks (study end)

    Study Formula Satisfaction Questionnaire

  2. Standard adverse events (AEs) reporting for safety assessment

    Time frame: From the time the informed consent form has been signed at enrollment infant age less than 7 days to 2 months through the 8 weeks of intervention

    Reported adverse events (AEs) and Serious Adverse Events (SAEs) include type, incidence, severity, seriousness and relation to feeding

  3. Weight

    Time frame: 8 weeks (study end)

    Weight measurements in grams

  4. Length

    Time frame: 8 weeks (study end)

    Length measurements in centimeters

  5. Head circumference

    Time frame: 8 weeks (study end)

    Head circumference measurements in centimeters

  6. Body-mass-index (BMI)

    Time frame: 8 weeks (study end)

    Weight and height will be combined to report BMI in kg/m^2

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • Casa de la Salud Hospital
  • Grupo Hispalense de Pediatría Hospital
  • Grupo Pulso
  • Hospital Ruber Internacional
  • MH Belén Maternal Hospital
  • Puerta de Hierro University Hospital
  • Quirón-Dexeus Universitary Hospital
  • University of Navarrra Hospital (Clinica Universitaria)
  • Vitha Santa Catalina Hospital

Registry information

Official study title

Growth and Feeding Tolerance of Infants Consuming a Formula Supplemented With Human Milk Oligosaccharides (HMOs): An Uncontrolled, Open-label, Prospective Study

Acronym: NEHMO

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 13, 2019
Registry last updated
Aug 13, 2019

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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