Infant Nutritional Physiological PhenomenaNCT05097924
Gastrointestinal Tolerability of a Partially Hydrolyzed Ready-to-feed Infant Formula in Healthy Newborns
An observational study of Infant Nutritional Physiological Phenomena and Infant Formula, run by Société des Produits Nestlé (SPN) at 1 site in Saudi Arabia.
Trial summary
Gastrointestinal tolerability of a partially hydrolyzed, whey-based, ready-to-feed infant formula in healthy newborns during the birth hospitalization period: a post-market study Read more about this study
- Who is it for?
- Ages 0 to 24 months
- Conditions the study is for
- Infant Nutritional Physiological Phenomena, Infant Formula
- What is being tested?
- NAN Supreme HypoAllergenic Starter Infant Formula in ready-to-feed format
- How many people
- 150 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2022to 9 Mar 2022
- Phase
- Observational
- 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 0 to 24 months
- All sexes
- Child
Study population: Newborn infants
Who may be able to join
- Written informed consent has been obtained from both parents or a legally acceptable representative (LAR).
- Full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2500 g and ≤ 4500 g.
- Parent(s) must have independently elected, before enrollment, to formula feed.
- Infant age ≤ 24 hours after birth.
- Child's parents / LAR are of legal age of consent, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol.
Who cannot join
- Infant is exclusively breastfed.
- Evidence of significant cardiac, respiratory, endocrine, hematologic, gastrointestinal, or other systemic diseases, infections, or disorders.
- Infant has other condition that, in the judgement of the investigator, would make the infant inappropriate for entry into the study.
- Conditions that require infant feedings other than those specified in the protocol.
- Infant is currently participating in another interventional clinical trial that impacts study outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastrointestinal Tolerability of a Partially Hydrolyzed, Whey-based, Ready-to-feed Infant Formula in Healthy Newborns During the Birth Hospitalization Period: a Post-market Study
Gastrointestinal tolerability of a partially hydrolyzed, whey-based, ready-to-feed infant formula in healthy newborns during the birth hospitalization period: a post-market study
- Being tested
- NAN Supreme HypoAllergenic Starter Infant Formula in ready-to-feed format
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAN Supreme HypoAllergenic Starter Infant Formula in ready-to-feed formatOther
Post-market observational study with formula feeding administered via standard of care
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent-reported individual gastrointestinal (GI) symptoms and GI-related behaviors
The Newborn Infant GI Tolerance eDiary will be completed daily (preferably in the evening) by parents, who will document the frequency and severity of diarrhea, gassiness, spitting-up, vomiting, reflux, abdominal pain, fussiness, crying, and sleep patterns using a 6-point scale (from Never to Always). Higher scores indicate more symptoms of GI discomfort.
Measured: Daily through study completion (age 2 to 5 days)
Parent-reported individual GI- and feeding-related behaviors
At discharge, parents will complete the Gastrointestinal Tract Function sub-scale of the NeoEAT questionnaire (either the Bottle-Feeding or the Mixed-Feeding version, depending on the mother's chosen feeding mode) to document GI- and feeding-related behaviors using a 6-point scale (from Never to Always). Higher scores indicate more symptoms of GI discomfort and problematic feeding behavior.
Measured: At study completion (age 2 to 5 days)
Number of infants with specific GI characteristics
GI symptoms and GI-related behaviors, as documented by health care providers in the infants' hospital medical charts (e.g., diarrhea, constipation, and vomiting)
Measured: Daily through study completion (age 2 to 5 days)
Number of feeds per day
Number of formula feeds per day, number of breastfeeds per day (if mixed fed), as documented by health care providers in the infants' hospital medical charts
Measured: Daily through study completion (age 2 to 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Feb 2022
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Nutritional Physiological PhenomenaStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097924
- Sponsor's protocol ID
- 21.07.INF
- Status last verified
- Jul 2022
- First submitted
- 4 Oct 2021
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Tolerability of a Partially Hydrolyzed, Whey-based, Ready-to-feed Infant Formula in Healthy Newborns During the Birth Hospitalization Period: a Post-market Study
- ClinicalTrials.gov ID
- NCT05097924
- Acronym / sponsor ID
- 21.07.INF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 28 Oct 2021 (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.
Gastrointestinal tolerability of a partially hydrolyzed, whey-based, ready-to-feed infant formula in healthy newborns during the birth hospitalization period: a post-market study
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 24 months
- Sex
- All
- Age groups
- Child
- Study population
- Newborn infants
Key inclusion criteria (5 listed)
- Written informed consent has been obtained from both parents or a legally acceptable representative (LAR).
- Full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2500 g and ≤ 4500 g.
- Parent(s) must have independently elected, before enrollment, to formula feed.
- Infant age ≤ 24 hours after birth.
- Child's parents / LAR are of legal age of consent, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol.
Key exclusion criteria (5 listed)
- Infant is exclusively breastfed.
- Evidence of significant cardiac, respiratory, endocrine, hematologic, gastrointestinal, or other systemic diseases, infections, or disorders.
- Infant has other condition that, in the judgement of the investigator, would make the infant inappropriate for entry into the study.
- Conditions that require infant feedings other than those specified in the protocol.
- Infant is currently participating in another interventional clinical trial that impacts study outcomes.
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 |
|---|---|---|
| NAN Supreme HypoAllergenic Starter Infant Formula in ready-to-feed formatPost-market observational study with formula feeding administered via standard of care | Other | – |
Primary outcome
Parent-reported individual gastrointestinal (GI) symptoms and GI-related behaviors
Time frame: Daily through study completion (age 2 to 5 days)
The Newborn Infant GI Tolerance eDiary will be completed daily (preferably in the evening) by parents, who will document the frequency and severity of diarrhea, gassiness, spitting-up, vomiting, reflux, abdominal pain, fussiness, crying, and sleep patterns using a 6-point scale (from Never to Always). Higher scores indicate more symptoms of GI discomfort.
Parent-reported individual GI- and feeding-related behaviors
Time frame: At study completion (age 2 to 5 days)
At discharge, parents will complete the Gastrointestinal Tract Function sub-scale of the NeoEAT questionnaire (either the Bottle-Feeding or the Mixed-Feeding version, depending on the mother's chosen feeding mode) to document GI- and feeding-related behaviors using a 6-point scale (from Never to Always). Higher scores indicate more symptoms of GI discomfort and problematic feeding behavior.
Number of infants with specific GI characteristics
Time frame: Daily through study completion (age 2 to 5 days)
GI symptoms and GI-related behaviors, as documented by health care providers in the infants' hospital medical charts (e.g., diarrhea, constipation, and vomiting)
Number of feeds per day
Time frame: Daily through study completion (age 2 to 5 days)
Number of formula feeds per day, number of breastfeeds per day (if mixed fed), as documented by health care providers in the infants' hospital medical charts
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 6 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Nutritional Physiological Phenomena and Infant Formula, run by Société des Produits Nestlé (SPN) at 1 site in Saudi Arabia.
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 5 inclusion and 5 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 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. 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?
Parent-reported individual gastrointestinal (GI) symptoms and GI-related behaviors (time frame: Daily through study completion (age 2 to 5 days)). The study lists 4 primary outcomes in all. 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 6 Jul 2022.