Growth Clinical Trial
— NEHMOOfficial title:
Growth and Feeding Tolerance of Infants Consuming a Formula Supplemented With Human Milk Oligosaccharides (HMOs): An Uncontrolled, Open-label, Prospective Study
Verified date | August 2019 |
Source | Nestlé |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 207 |
Est. completion date | December 31, 2018 |
Est. primary completion date | November 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 2 Months |
Eligibility |
Inclusion Criteria: 1. 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 2. Parent(s) are willing and able to fulfill the requirements of the study protocol 3. Healthy full term (37-42 weeks gestation) infant 4. Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months 5. Parent(s) must have independently elected, before enrollment, to formula feed Exclusion Criteria: 1. 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 2. Parent(s) are willing and able to fulfill the requirements of the study protocol 3. Healthy full term (37-42 weeks gestation) infant 4. Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months 5. 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Universitary Hospital Quirón-Dexeus | Barcelona | |
Spain | Hospital Maternal MH Belén | Coruña | Galicia |
Spain | Vitha Santa Catalina Hospital | Las Palmas De Gran Canaria | Canarias |
Spain | Ruber Internacional Clinic | Madrid | |
Spain | Hispalense Group | Sevilla | |
Spain | Casa de la Salud, Hospital | Valencia |
Lead Sponsor | Collaborator |
---|---|
Nestlé | Casa de la Salud Hospital, Grupo Hispalense de Pediatría Hospital, MH Belén Maternal Hospital, Puerta de Hierro University Hospital, Pulso Group, Knowledge and Health, Quirón-Dexeus Universitary Hospital, Rúber Internacional Hospital, University of Navarrra Hospital (Clinica Universitaria), Vitha Santa Catalina Hospital |
Spain,
Storm HM, Shepard J, Czerkies LM, Kineman B, Cohen SS, Reichert H, Carvalho R. 2'-Fucosyllactose Is Well Tolerated in a 100% Whey, Partially Hydrolyzed Infant Formula With Bifidobacterium lactis: A Randomized Controlled Trial. Glob Pediatr Health. 2019 Mar 15;6:2333794X19833995. doi: 10.1177/2333794X19833995. eCollection 2019. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | World Health Organization (WHO) based weight-for-age z-scores | Weight-for-age z-scores using WHO growth standards | 8 weeks (study end) | |
Primary | World Health Organization (WHO) based length-for-age z-scores | Length-for-age z-scores using WHO growth standards | 8 weeks (study end) | |
Primary | World Health Organization (WHO) weight-for-length z-scores | Weight-for-length z-scores using WHO growth standards | 8 weeks (study end) | |
Primary | World Health Organization (WHO) head-circumference-for-age z-scores | head-circumference-for-age z-scores using WHO growth standards | 8 weeks (study end) | |
Primary | World Health Organization (WHO) based body-mass-index (BMI)-for-age z-scores | 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 | 8 weeks (study end) | |
Primary | Feeding tolerance | 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. | 4 weeks (study midpoint) | |
Primary | Feeding tolerance | 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. | 8 weeks (study end) | |
Secondary | Formula acceptability | Study Formula Satisfaction Questionnaire | 4 weeks (study midpoint), 8 weeks (study end) | |
Secondary | Standard adverse events (AEs) reporting for safety assessment | Reported adverse events (AEs) and Serious Adverse Events (SAEs) include type, incidence, severity, seriousness and relation to feeding | 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 | |
Secondary | Weight | Weight measurements in grams | 8 weeks (study end) | |
Secondary | Length | Length measurements in centimeters | 8 weeks (study end) | |
Secondary | Head circumference | Head circumference measurements in centimeters | 8 weeks (study end) | |
Secondary | Body-mass-index (BMI) | Weight and height will be combined to report BMI in kg/m^2 | 8 weeks (study end) |
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