Infant, Premature, NutritionNCT03055052
Clinical Effects of a Formula With Modified Protein Levels and Fat Blend in Preterm Infants
A study testing Standard formula for preterm infants and Formula with higher protein and new fat blend for preterm infants in people with Infant, Premature, Nutrition, run by Société des Produits Nestlé (SPN) at 1 site in Vietnam.
Trial summary
This study evaluates the effects of infant formula with higher protein level and improved fat blend on growth and feeding tolerance in preterm infants. Half of the subjects will receive a standard infant formula, while the other half will receive a infant formula with a higher protein level and improved fat blend. Read more about this study
- Who is it for?
- Ages Up to 33 weeks
- Conditions the study is for
- Infant, Premature, Nutrition
- What is being tested?
- Standard formula for preterm infants and Formula with higher protein and new fat blend for preterm infants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteVietnam
- Study dates
- Jan 2017to 25 Jun 2018
- 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 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Less than or equal to 33 weeks 0 days
- Birth weight less than or equal to 2000g.
- Infant is anticipated to receive the study formula for ≥ 3 consecutive weeks
- At entry into Full Enteral Feeding, study formula will be provided at 50% or more of total enteral feedings.
- Written informed consent has been obtained from the parent/legally authorized representative (LAR).
Who cannot join
- Peri-/intra-ventricular hemorrhage
- Renal disease
- Hepatic dysfunction
- Major congenital malformations
- Suspected or documented systemic or congenital infections
- Cardiac, respiratory, endocrinologic, hematologic, GI, or other systemic diseases that may impact growth
- Suspected or documented maternal substance abuse
- Infants who have received any experimental treatment or intervention
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effects of infant formula with higher protein level and improved fat blend on growth and feeding tolerance in preterm infants. Half of the subjects will receive a standard infant formula, while the other half will receive a infant formula with a higher protein level and improved fat blend.
Read the detailed description
When an infant is born prematurely, the supply of nutrients supporting normal growth and development is interrupted. There is less time to accrue adequate nutrient stores and foetal tissue. The nutritional goal for the preterm infant is to have satisfactory functional development and catch up on growth to match the rate of a full term infant. To achieve this, it is recommended for the infant to have adequate protein intake and suitable fat blend.
- Conditions
- Infant, Premature, Nutrition
- Being tested
- Standard formula for preterm infants, Formula with higher protein and new fat blend for preterm infants
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard formula for preterm infantsOther
Reconstituted in water and given to infants at more than 50% of feedings.
Formula with higher protein and new fat blend for preterm infantsOther
Reconstituted in water and given to infants at more than 50% of feedings.
| Study group | Role | What they receive |
|---|---|---|
| Control Formula | Active comparator | Standard formula for preterm infants. Receives: Other: Standard formula for preterm infants |
| Experimental formula | Experimental | Formula with higher protein and new fat blend for preterm infants. Receives: Other: Formula with higher protein and new fat blend for preterm infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth in terms of weight gain per day
Measured: 21 days
Secondary outcomes (3)
Growth in terms of length and head circumference
Measured: Till infant reaches 3kg (study completion), expected within 3 months
Feeding tolerance (frequency of regurgitation, stool frequency and consistency)
Measured: Till infant reaches 3kg (study completion), expected within 3 months
Incidence of adverse events
Measured: 30 days post infant stopping study infant formula intake upon reaching 3kg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study startJan 2017
- Primary completion18 Mar 2018
- Study completion25 Jun 2018
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 Infant, Premature, NutritionStudies 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
- 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leslie Tan, Study chair, Société des Produits Nestlé (SPN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055052
- Sponsor's protocol ID
- 14.25.INF
- Status last verified
- Aug 2018
- First submitted
- 26 Jan 2017
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Thanh LQ, Chen Y, Hartweg M, Thi Nguyen TA. Effects of higher protein formula with improved fat blend on growth, feeding tolerance and nutritional biomarkers in preterm infants: A double-blind, randomized, controlled clinical trial. Pediatr Neonatol. 2022 May;63(3):227-238. doi: 10.1016/j.pedneo.2021.09.007. Epub 2021 Dec 4.
PubMed 35000893
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of a Formula With Modified Protein Levels and Fat Blend in Preterm Infants
- ClinicalTrials.gov ID
- NCT03055052
- Acronym / sponsor ID
- 14.25.INF
- Conditions
- Infant, Premature, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- 18 Mar 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 16 Feb 2017 (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.
This study evaluates the effects of infant formula with higher protein level and improved fat blend on growth and feeding tolerance in preterm infants. Half of the subjects will receive a standard infant formula, while the other half will receive a infant formula with a higher protein level and improved fat blend.
Detailed description
When an infant is born prematurely, the supply of nutrients supporting normal growth and development is interrupted. There is less time to accrue adequate nutrient stores and foetal tissue. The nutritional goal for the preterm infant is to have satisfactory functional development and catch up on growth to match the rate of a full term infant. To achieve this, it is recommended for the infant to have adequate protein intake and suitable fat blend.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Formula | Active comparator | Other: Standard formula for preterm infantsStandard formula for preterm infants. |
| Experimental formula | Experimental | Other: Formula with higher protein and new fat blend for preterm infantsFormula with higher protein and new fat blend for preterm infants. |
Who may qualify
- Ages
- Up to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Less than or equal to 33 weeks 0 days
- Birth weight less than or equal to 2000g.
- Infant is anticipated to receive the study formula for ≥ 3 consecutive weeks
- At entry into Full Enteral Feeding, study formula will be provided at 50% or more of total enteral feedings.
- Written informed consent has been obtained from the parent/legally authorized representative (LAR).
Key exclusion criteria (8 listed)
- Peri-/intra-ventricular hemorrhage
- Renal disease
- Hepatic dysfunction
- Major congenital malformations
- Suspected or documented systemic or congenital infections
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 formula for preterm infantsReconstituted in water and given to infants at more than 50% of feedings. | Other | Control Formula |
| Formula with higher protein and new fat blend for preterm infantsReconstituted in water and given to infants at more than 50% of feedings. | Other | Experimental formula |
Primary outcome
Growth in terms of weight gain per day
Time frame: 21 days
3 secondary outcomes
Growth in terms of length and head circumference
Time frame: Till infant reaches 3kg (study completion), expected within 3 months
Feeding tolerance (frequency of regurgitation, stool frequency and consistency)
Time frame: Till infant reaches 3kg (study completion), expected within 3 months
Incidence of adverse events
Time frame: 30 days post infant stopping study infant formula intake upon reaching 3kg
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 3 Aug 2018.
- Derived from this study: PubMed 35000893Thanh LQ, Chen Y, Hartweg M, Thi Nguyen TA. Effects of higher protein formula with improved fat blend on growth, feeding tolerance and nutritional biomarkers in preterm infants: A double-blind, randomized, controlled clinical trial. Pediatr Neonatol. 2022 May;63(3):227-238. doi: 10.1016/j.pedneo.2021.09.007. Epub 2021 Dec 4.
- 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.
Leslie Tan study chair
Société des Produits Nestlé (SPN)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard formula for preterm infants and Formula with higher protein and new fat blend for preterm infants in people with Infant, Premature, Nutrition, run by Société des Produits Nestlé (SPN) at 1 site in Vietnam.
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 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 3 Aug 2018. 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 Vietnam. 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?
Growth in terms of weight gain per day (time frame: 21 days). 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 NCT03055052, 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 3 Aug 2018.