Fussy Infant (Baby)NCT05245422
Acceptance of a Partially Hydrolyzed Formula
A study testing Infant Formula - Partially hydrolyzed protein and Infant Formula - Intact protein in people with Fussy Infant (Baby), run by Mead Johnson Nutrition at 11 sites in United States.
Trial summary
A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to evaluate the nutritive effects of a partially hydrolyzed cow's milk protein infant formula on infant fussiness. Read more about this study
- Who is it for?
- Ages 15 to 75 days
- Conditions the study is for
- Fussy Infant (Baby)
- What is being tested?
- Infant Formula - Partially hydrolyzed protein and Infant Formula - Intact protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 11 sitesUnited States
- Study dates
- 28 Feb 2022to 14 Jul 2023
- 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 15 to 75 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary caregiver has reliable access to the internet and a reliable device (such as a computer, tablet, or smartphone) to access mobile apps and be able to view and complete study questionnaires
- Singleton birth
- 15 to 75 days of age at Visit 1, inclusive (day of birth is considered Day 0)
- Gestational age of ≥37 to 42 weeks (36 weeks and six days is considered 36 weeks' gestational age)
- Birth weight of 2500 g (5 lbs 8 oz) or more
- Exclusively receiving an intact protein infant formula (cow's milk-based or plant-based) for 7 days prior to Visit 1
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- Answer to question: "On average, how fussy has your baby been over the past 3 days" is moderately fussy, very fussy, or extremely fussy at Visit 1
- Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period
- Parent(s) or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
- Signed informed consent obtained from parent or legal guardian for infant's participation in the study
- Signed authorization obtained from parent or legal guardian to use and/or disclose Protected Health Information for infant from birth through the length of the study period
Who cannot join
- Infant has been weighed by a health care professional (HCP) and is identified with inadequate weight gain or failure-to-thrive
- Diagnosis or suspicion of cow's milk protein allergy by a healthcare professional
- Any acute illness within the 3 days prior to Visit 1
- Infant has had immunizations or a surgical procedure within the 3 days prior to or on Visit 1
- Immunizations are planned for the infant during any of the 7 days after Visit 1
- Use of oral, intramuscular or intravenous antibiotics within the 7 days prior to Visit 1
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- Infant has had bloody stools (visible to the naked eye) within the 7 days prior to Visit 1
- Infant has been taking medication (prescribed and over-the-counter) for gastrointestinal conditions for any of the 7 days prior to Visit 1 (however, probiotics are allowed)
- Infant has a surgical procedure planned during the study period
- History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
- History of underlying neurological or organic disease likely to cause fussiness, such as (but not limited to) a doctor's diagnosis of neonatal abstinence syndrome and inflammatory or orthopedic disorders
- Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as combined immunodeficiencies, DiGeorge syndrome, Wiskott-Aldrich syndrome, severe congenital neutropenia and secondary immunodeficiencies linked to HIV infection, Down syndrome or others)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Birmingham Pediatric Associates
Birmingham, Alabama, 35205
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
Meridian Clinical Research
Charleston, South Carolina, 29414
South Texas Pediatric Research Group
Del Rio, Texas, 78840
Proactive Clinical Research
Edinburg, Texas, 78539
Tribe Clinical Research
Greenville, South Carolina, 29607
Frontier Pediatric Research
Lincoln, Nebraska, 68502
AVIATI Healthcare & Clinical Research
Memphis, Tennessee, 38115
DBC Research USA
Miramar, Florida, 33025
Mid Valley Research Inc.
Moline, Illinois, 61265
Proactive Clinical Research
Sarasota, Florida, 34243
About this study
Official title: Parent And Infant Relief (PAIR): Acceptance of a Partially Hydrolyzed Formula
A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to evaluate the nutritive effects of a partially hydrolyzed cow's milk protein infant formula on infant fussiness.
Read the detailed description
A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to evaluate the nutritive effects of a partially hydrolyzed cow's milk protein (PHP) infant formula on infant fussiness. Formula tolerance and intake, sleep characteristics, stool characteristics, parental quality of life, and medically confirmed adverse events will be compared between i two study groups.
- Conditions
- Fussy Infant (Baby)
- Being tested
- Infant Formula - Partially hydrolyzed protein, Infant Formula - Intact protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Formula - Partially hydrolyzed proteinOther
Partially hydrolyzed cow's milk protein
Infant Formula - Intact proteinOther
Intact cow's milk protein
| Study group | Role | What they receive |
|---|---|---|
| Cow's milk intact protein infant formula | Active comparator | Control Receives: Other: Infant Formula - Intact protein |
| Partially hydrolyzed cow's milk protein infant formula | Experimental | Investigational Receives: Other: Infant Formula - Partially hydrolyzed protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fussiness
Daily Diary
Measured: Study Feeding Days 1 through 7
Secondary outcomes (11)
Fussiness
Daily Diary
Measured: Study Feeding Days 8-28
Gassiness
Daily Diary
Measured: Study Feeding Days 1-28
Crying
Daily Diary
Measured: Study Feeding Days 1-28
Spit-up
Daily Diary
Measured: Study Feeding Days 1-28
Sleep
Daily Diary
Measured: Study Feeding Days 1-28
Stool frequency
Daily Diary
Measured: Study Feeding Days 1-28
Stool consistency
Daily Diary
Measured: Study Feeding Days 1-28
Study Formula Intake
24-hour Recall of Study Formula Intake
Measured: Study Feeding Day 7 and Study Feeding Day 25 (+3 days)
Brief Infant Sleep Questionnaire
Revised Short Form (BISQ-R SF)
Measured: Study Feeding Day 14 (+2 days) and Study Feeding Day 25 (+ 3 days)
Quality of Life Questionnaire
Pediatric Quality of Life Inventory™ Family Impact Module (PedsQL FIM)-Acute
Measured: Study Feeding Day 7 (+2 days) and Study Feeding Day 25 (+3 days)
Medically confirmed adverse events
Collected from medical records
Measured: Day 1 through end of feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start28 Feb 2022
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fussy Infant (Baby)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245422
- Sponsor's protocol ID
- 3392-1
- Status last verified
- Jun 2025
- First submitted
- 11 Jan 2022
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fabrizio V, Bohan Brown MM, Boucher P, Boyd S, Cao S, Davis C, Johnson S, Khan N, Moore N, Muse K, Ogwara F, Patterson AC, Wampler JL, Yeiser M, Zhuang W, Wu SS. A Randomized Controlled Trial of a Partially Hydrolyzed Formula on Comfort Measures in Fussy Infants. Curr Dev Nutr. 2025 Oct 13;9(11):107574. doi: 10.1016/j.cdnut.2025.107574. eCollection 2025 Nov.
PubMed 41323693
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent And Infant Relief (PAIR): Acceptance of a Partially Hydrolyzed Formula
- ClinicalTrials.gov ID
- NCT05245422
- Acronym / sponsor ID
- 3392-1
- Conditions
- Fussy Infant (Baby)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 18 Feb 2022 (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.
A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to evaluate the nutritive effects of a partially hydrolyzed cow's milk protein infant formula on infant fussiness.
Detailed description
A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to evaluate the nutritive effects of a partially hydrolyzed cow's milk protein (PHP) infant formula on infant fussiness. Formula tolerance and intake, sleep characteristics, stool characteristics, parental quality of life, and medically confirmed adverse events will be compared between i two study groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cow's milk intact protein infant formula | Active comparator | Other: Infant Formula - Intact proteinControl |
| Partially hydrolyzed cow's milk protein infant formula | Experimental | Other: Infant Formula - Partially hydrolyzed proteinInvestigational |
Who may qualify
- Ages
- 15 to 75 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Primary caregiver has reliable access to the internet and a reliable device (such as a computer, tablet, or smartphone) to access mobile apps and be able to view and complete study questionnaires
- Singleton birth
- 15 to 75 days of age at Visit 1, inclusive (day of birth is considered Day 0)
- Gestational age of ≥37 to 42 weeks (36 weeks and six days is considered 36 weeks' gestational age)
- Birth weight of 2500 g (5 lbs 8 oz) or more
Key exclusion criteria (12 listed)
- Infant has been weighed by a health care professional (HCP) and is identified with inadequate weight gain or failure-to-thrive
- Diagnosis or suspicion of cow's milk protein allergy by a healthcare professional
- Any acute illness within the 3 days prior to Visit 1
- Infant has had immunizations or a surgical procedure within the 3 days prior to or on Visit 1
- Immunizations are planned for the infant during any of the 7 days after Visit 1
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 |
|---|---|---|
| Infant Formula - Partially hydrolyzed proteinPartially hydrolyzed cow's milk protein | Other | Partially hydrolyzed cow's milk protein infant formula |
| Infant Formula - Intact proteinIntact cow's milk protein | Other | Cow's milk intact protein infant formula |
Primary outcome
Fussiness
Time frame: Study Feeding Days 1 through 7
Daily Diary
11 secondary outcomes
Fussiness
Time frame: Study Feeding Days 8-28
Gassiness
Time frame: Study Feeding Days 1-28
Crying
Time frame: Study Feeding Days 1-28
Spit-up
Time frame: Study Feeding Days 1-28
Sleep
Time frame: Study Feeding Days 1-28
Stool frequency
Time frame: Study Feeding Days 1-28
Stool consistency
Time frame: Study Feeding Days 1-28
Study Formula Intake
Time frame: Study Feeding Day 7 and Study Feeding Day 25 (+3 days)
Brief Infant Sleep Questionnaire
Time frame: Study Feeding Day 14 (+2 days) and Study Feeding Day 25 (+ 3 days)
Quality of Life Questionnaire
Time frame: Study Feeding Day 7 (+2 days) and Study Feeding Day 25 (+3 days)
Medically confirmed adverse events
Time frame: Day 1 through end of feeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Derived from this study: PubMed 41323693Fabrizio V, Bohan Brown MM, Boucher P, Boyd S, Cao S, Davis C, Johnson S, Khan N, Moore N, Muse K, Ogwara F, Patterson AC, Wampler JL, Yeiser M, Zhuang W, Wu SS. A Randomized Controlled Trial of a Partially Hydrolyzed Formula on Comfort Measures in Fussy Infants. Curr Dev Nutr. 2025 Oct 13;9(11):107574. doi: 10.1016/j.cdnut.2025.107574. eCollection 2025 Nov.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Formula - Partially hydrolyzed protein and Infant Formula - Intact protein in people with Fussy Infant (Baby), run by Mead Johnson Nutrition at 11 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 11 inclusion and 12 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: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fussiness (time frame: Study Feeding Days 1 through 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05245422, which also lists 1 linked publication.
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 18 Jun 2025.