Infant Term BirthNCT02598817
Acceptability and Gastrointestinal Tolerance of a High-Sn-2 Infant Formula
An observational study of Infant Term Birth, run by Société des Produits Nestlé (SPN) at 5 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal (GI) Tolerance. Read more about this study
- Who is it for?
- Ages 2 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant Term Birth
- What is being tested?
- Standard Infant Formula
- How many people
- 276 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Jul 2018to 5 Jan 2021
- 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 2 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: 500 healthy, full-term, formula fed infants
Who may be able to join
- Formula fed healthy full term infants with normal birth weight (2500g 4000g)
- Partially breast and formula fed infants who drink at least 2 formula feedings per day; each to be at least 30ml
- Infants of both genders at age of 2 weeks to 12 weeks
- Infants of parents providing written informed consent before any study related activities are carried out
Who cannot join
- Preterm or IUGR babies
- Contraindication of standard infant formula
- Infants who have allergy of cow's milk protein
- Infants with Serious medical or surgical GI disease
- Infants with multiple congenital anomalies
- Infants with suspected chromosomal or metabolic disorder
- Infants of mothers with a health condition or socioeconomic problems that may interfere with their ability to take care of their infants
- Infants of parents who refuse to participate in the study
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Saudi Arabia3 sites
Tadawi General Hospital
Dammam
Almana Hospital
Jubail
Al Mouasat Hospital
Riyadh
United Arab Emirates2 sites
Sheikh Khalifa Medical City
Abu Dhabi
Al Garhoud Private Hospital
Dubai
About this study
Official title: Acceptability of "High Sn-2" Infant Formula in Non-Breast Fed Healthy Term Infants Regarding Gastrointestinal Tolerability by Both Parents and Pediatrician. An Open Label Pilot Study Evaluation in the Gulf Cooperation Council (GCC) Countries.
The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal (GI) Tolerance.
Read the detailed description
This is a multicenter, open label, observation study; 500 formula fed infants are planned to be enrolled from a network of general pediatricians in the Gulf countries (UAE, Kuwait, Qatar, and KSA). Eligible infants will consume a high sn-2 palmitate infant formula for 12 weeks. All enrolled infants will be evaluated at enrollment and at 4 weeks and 12 weeks.
- Conditions
- Infant Term Birth
- Being tested
- Standard Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Infant FormulaOther
Standard Infant Formula containing High Sn-2
| Study group | Role | What they receive |
|---|---|---|
| Standard Infant Formula | Standard Infant Formula containing High Sn-2 Receives: Other: Standard Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Stool Form Scale
frequency and consistency
Measured: 12 weeks
Secondary outcomes (3)
Changes from baseline to 12 weeks in Height centile
height (cm)
Measured: 12 weeks
Changes from baseline to 12 weeks in Weight centile
weight(kg) and respective Wt z-scores
Measured: 12 weeks
Changes from baseline to 12 weeks in Head Circumference centile
Head circumference (cm)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study start1 Jul 2018
- Primary completion8 Jan 2020
- Study completion5 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Term BirthStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Islam Tawfiq Al Baroudi, MD, Principal investigator, Pediatric Gastroenterologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598817
- Sponsor's protocol ID
- 15.17.INF.ME
- Status last verified
- Feb 2023
- First submitted
- 28 Oct 2015
- Last updated
- 24 Feb 2023
- 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 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of "High Sn-2" Infant Formula in Non-Breast Fed Healthy Term Infants Regarding Gastrointestinal Tolerability by Both Parents and Pediatrician. An Open Label Pilot Study Evaluation in the Gulf Cooperation Council (GCC) Countries.
- ClinicalTrials.gov ID
- NCT02598817
- Acronym / sponsor ID
- 15.17.INF.ME
- Conditions
- Infant Term Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 6 Nov 2015 (estimated)
- 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 study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal (GI) Tolerance.
Detailed description
This is a multicenter, open label, observation study; 500 formula fed infants are planned to be enrolled from a network of general pediatricians in the Gulf countries (UAE, Kuwait, Qatar, and KSA). Eligible infants will consume a high sn-2 palmitate infant formula for 12 weeks. All enrolled infants will be evaluated at enrollment and at 4 weeks and 12 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard Infant Formula | – | Other: Standard Infant FormulaStandard Infant Formula containing High Sn-2 |
Who may qualify
- Ages
- 2 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 500 healthy, full-term, formula fed infants
Key inclusion criteria (4 listed)
- Formula fed healthy full term infants with normal birth weight (2500g 4000g)
- Partially breast and formula fed infants who drink at least 2 formula feedings per day; each to be at least 30ml
- Infants of both genders at age of 2 weeks to 12 weeks
- Infants of parents providing written informed consent before any study related activities are carried out
Key exclusion criteria (8 listed)
- Preterm or IUGR babies
- Contraindication of standard infant formula
- Infants who have allergy of cow's milk protein
- Infants with Serious medical or surgical GI disease
- Infants with multiple congenital anomalies
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 |
|---|---|---|
| Standard Infant FormulaStandard Infant Formula containing High Sn-2 | Other | Standard Infant Formula |
Primary outcome
Infant Stool Form Scale
Time frame: 12 weeks
frequency and consistency
3 secondary outcomes
Changes from baseline to 12 weeks in Height centile
Time frame: 12 weeks
Changes from baseline to 12 weeks in Weight centile
Time frame: 12 weeks
Changes from baseline to 12 weeks in Head Circumference centile
Time frame: 12 weeks
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 24 Feb 2023.
Related trials for Infant Term Birth
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
Neurodevelopmental Disorders, Motor Skills Disorders
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
Not yet recruiting
Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
Very Premature Baby
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.
Islam Tawfiq Al Baroudi, MD principal investigator
Pediatric Gastroenterologist
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Term Birth, run by Société des Produits Nestlé (SPN) at 5 sites in 2 countries.
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 4 inclusion and 8 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 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Saudi Arabia, United Arab Emirates. 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?
Infant Stool Form Scale (time frame: 12 weeks). 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 24 Feb 2023.