Respiratory Infections in ChildrenNCT04495738
Infant Formula and Toddler Drink Feeding Intervention
A study testing Experimental Infant Formula, Experimental Toddler Drink and Supplemental Formula for HM Group in people with Respiratory Infections in Children, run by Abbott Nutrition at 27 sites in United States.
Trial summary
The purpose of this randomized, multi-center, controlled, double-blind, parallel study is to evaluate the health and developmental outcomes of children fed a new infant formula and toddler drink through 24 months of age. Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Respiratory Infections in Children
- What is being tested?
- Experimental Infant Formula, Experimental Toddler Drink and Supplemental Formula for HM Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 27 sitesUnited States
- Study dates
- 10 Aug 2020to 12 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant is judged to be in good health as determined from participant's medical history
- Participant is a singleton from a full-term birth with a gestational age of 37 - 42 weeks
- Participant's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)
- If parent(s) elect to formula feed the participant they confirm their intention to feed their participant the study product as the sole source of feeding until 4 months of age, and as the sole milk beverage during the first 12 months of life
- If parent(s) elect to formula feed the participant, they confirm their intention to feed the participant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage
- If parent(s) elect to feed the participant mother's human milk, they confirm that their infant was exclusively fed mother's human milk since birth and confirm their intention to continue exclusively feeding human milk as the sole source of feeding through 4 months of age
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- If parent(s) of human milk fed participant elect to supplement or wean after 4 months to 24 months of age, they confirm their intention to use the supplemental/weaning formula or toddler drink as the primary milk beverage
- Parent(s) of formula-fed participant confirm their intention not to administer vitamin or mineral supplements, from enrollment through the duration of the study
- Parent(s) confirm their intention not to administer solid foods or juices to the participant from enrollment through 6 months of age
- Participant's parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
Who cannot join
- 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 medications (including over the counter (OTC), home remedies, herbal preparations, prebiotics or probiotics, or rehydration fluids that might affect GI tolerance
- Participant is in another study that has not been approved as a concomitant study
- Participant has been treated with antibiotics prior to enrollment
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
TOPAZ Clinical Research, Inc.
Apopka, Florida, 32703
Meridian Clinical Research 3080
Baton Rouge, Louisiana, 70806
Ohio Pediatric Research Association
Dayton, Ohio, 45414
MultiCare Institute for Research & Innovation
Dickinson, Texas, 77539
Southeastern Pediatric Associates
Dothan, Alabama, 36305
Qualmedica Research 3272
Evansville, Indiana, 47715
Deaconess Clinic, Inc.
Evansville, Indiana, 47725
Meridian Clinical Research 3264
Grand Island, Nebraska, 68803
Boeson Research 3266
Grand Junction, Colorado, 81505
Cyn3rgy Research
Gresham, Oregon, 97030
Meridian Clinical Research 3263
Hastings, Nebraska, 68901
Clinical Research Prime
Idaho Falls, Idaho, 83404
Leavitt Clinical Research
Idaho Falls, Idaho, 83404
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401
Boeson Research 3265
Kalispell, Montana, 59901
Holston Medical Group
Kingsport, Tennessee, 37660
Maximos Ob/Gyn
League City, Texas, 77573
Applied Research Center of Arkansas
Little Rock, Arkansas, 72019
DCOL Center for Clinical Research
Longview, Texas, 75605
Meridian Clinical Research 3259
Macon, Georgia, 31210
PAS Research 3273
McAllen, Texas, 78501
Boeson Research 3267
Missoula, Montana, 59804
Qualmedica Research, LLC 3270
Owensboro, Kentucky, 42301
Multicare Rockwood Pediatrics
Spokane, Washington, 99202
ASCLEPES Research Centers
Spring Hill, Florida, 34609
Mercury Clinical Research 3261
Tacoma, Washington, 98405
Eclipse Clinical Research
Tucson, Arizona, 85745
About this study
Official title: Infant Formula and Toddler Drink Feeding Intervention Through 24 Months of Age
The purpose of this randomized, multi-center, controlled, double-blind, parallel study is to evaluate the health and developmental outcomes of children fed a new infant formula and toddler drink through 24 months of age.
- Conditions
- Respiratory Infections in Children
- Being tested
- Control Infant Formula, Control Toddler Drink, Experimental Infant Formula, Experimental Toddler Drink, Supplemental Formula for HM Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Infant FormulaOther
Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
Control Toddler DrinkOther
16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
Experimental Infant FormulaOther
Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
Experimental Toddler DrinkOther
16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
Supplemental Formula for HM GroupOther
Ad libitum formula given up to 12 months of age if HM is supplemented
Toddler Drink for HM groupOther
16 fl oz per day if weaned from HM feedings
| Study group | Role | What they receive |
|---|---|---|
| Control Feeding Group | Active comparator | Ready to feed milk-based product Receives: Other: Control Infant Formula; Other: Control Toddler Drink |
| Experimental Feeding Group | Experimental | Ready to feed milk-based product with oligosaccharides Receives: Other: Experimental Infant Formula; Other: Experimental Toddler Drink |
| Human Milk (HM) Reference Group | Other | HM from infant's own mother and as needed supplemental infant formula and toddler milk-based product Receives: Other: Supplemental Formula for HM Group; Other: Toddler Drink for HM group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of respiratory infection between study groups
Adverse event reports
Measured: Study Day 1 to 6 Months of Age
Secondary outcomes (1)
Infection morbidity between study groups
Adverse event reports
Measured: Study Day 1 to 24 Months of Age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start10 Aug 2020
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Why it stopped: Change in research focus
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Infections in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bridget Barrett Reis, PhD, RD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495738
- Sponsor's protocol ID
- AL38
- Status last verified
- May 2021
- First submitted
- 29 Jul 2020
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Formula and Toddler Drink Feeding Intervention Through 24 Months of Age
- ClinicalTrials.gov ID
- NCT04495738
- Acronym / sponsor ID
- AL38
- Conditions
- Respiratory Infections in Children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in research focus
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized, multi-center, controlled, double-blind, parallel study is to evaluate the health and developmental outcomes of children fed a new infant formula and toddler drink through 24 months of age.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Feeding Group | Active comparator | Other: Control Infant Formula, Other: Control Toddler DrinkReady to feed milk-based product |
| Experimental Feeding Group | Experimental | Other: Experimental Infant Formula, Other: Experimental Toddler DrinkReady to feed milk-based product with oligosaccharides |
| Human Milk (HM) Reference Group | Other | Other: Supplemental Formula for HM Group, Other: Toddler Drink for HM groupHM from infant's own mother and as needed supplemental infant formula and toddler milk-based product |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Participant is judged to be in good health as determined from participant's medical history
- Participant is a singleton from a full-term birth with a gestational age of 37 - 42 weeks
- Participant's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)
- If parent(s) elect to formula feed the participant they confirm their intention to feed their participant the study product as the sole source of feeding until 4 months of age, and as the sole milk beverage during the first 12 months of life
- If parent(s) elect to formula feed the participant, they confirm their intention to feed the participant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage
Key exclusion criteria (4 listed)
- 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 medications (including over the counter (OTC), home remedies, herbal preparations, prebiotics or probiotics, or rehydration fluids that might affect GI tolerance
- Participant is in another study that has not been approved as a concomitant study
- Participant has been treated with antibiotics prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Infant FormulaAd libitum or as instructed by HCP, feeding period from enrollment to 12 months of age | Other | Control Feeding Group |
| Control Toddler Drink16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age | Other | Control Feeding Group |
| Experimental Infant FormulaAd libitum or as instructed by HCP, feeding period from enrollment to 12 months of age | Other | Experimental Feeding Group |
| Experimental Toddler Drink16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age | Other | Experimental Feeding Group |
| Supplemental Formula for HM GroupAd libitum formula given up to 12 months of age if HM is supplemented | Other | Human Milk (HM) Reference Group |
| Toddler Drink for HM group16 fl oz per day if weaned from HM feedings | Other | Human Milk (HM) Reference Group |
Primary outcome
Incidence of respiratory infection between study groups
Time frame: Study Day 1 to 6 Months of Age
Adverse event reports
1 secondary outcome
Infection morbidity between study groups
Time frame: Study Day 1 to 24 Months of Age
Results and safety
The study was stopped early (reason given: Change in research focus). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bridget Barrett Reis, PhD, RD study chair
Abbott Nutrition
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Infant Formula, Experimental Toddler Drink and Supplemental Formula for HM Group in people with Respiratory Infections in Children, run by Abbott Nutrition at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Change in research focus). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of respiratory infection between study groups (time frame: Study Day 1 to 6 Months of Age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021; AzTrials last refreshed its copy on 5 Nov 2026.